Horizon Scanning Technology Briefing. Prostate cancer gene 3 (Progensa PCA3) assay in the diagnosis of prostate cancer

Size: px
Start display at page:

Download "Horizon Scanning Technology Briefing. Prostate cancer gene 3 (Progensa PCA3) assay in the diagnosis of prostate cancer"

Transcription

1 Horizon Scanning Technology Briefing National Horizon Scanning Centre Prostate cancer gene 3 (Progensa PCA3) assay in the diagnosis of prostate cancer December 2006 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive statement on the safety, efficacy or effectiveness of the health technology covered and should not be used for commercial purposes.

2 Prostate cancer gene 3 (Progensa PCA3) assay in the diagnosis of prostate cancer Target group Men with raised prostate specific antigen (PSA) but a negative prostate biopsy. Other indications in early development include: o men with a slightly raised PSA, and o men with signs and symptoms suggestive of prostate cancer. Technology description Prostate cancer gene 3 (PCA3) is one of the most prostate cancer specific genes identified, with over-expression in approxiamately 95% of cancers tested 1. The PCA3 assay (Progensa PCA3, previously known as the upm3 assay from DiagnoCure) is an amplified nucleic acid assay, which uses transcription-mediated amplification (TMA) to quantify PCA3 and PSA mrna in prostate cells found in whole urine samples. The PCA3 score is calculated as the ratio between PCA3 and PSA mrna. Innovation and/or advantages The PCA3 test is a new non-invasive diagnostic test for prostate cancer with a high specificity and positive predictive value compared to current PSA testing, in men scheduled for prostate biopsy or prostatectomy. Developer Gen-Probe. Place of use Home care e.g. home dialysis Secondary care e.g. general, non-specialist hospital General public e.g. over the counter Community or residential care e.g. district nurses, physio Tertiary care e.g. highly specialist services or hospital Other: Primary care e.g. used by GPs or practice nurses Emergency care e.g. paramedic services, trauma care Availability, launch or marketing dates, and licensing plans: The Progensa PCA3 assay was CE marked in November It is available in the UK from Medi-Lab and The Doctors Laboratory. NHS or Government priority area: Cancer Cardiovascular disease Children Diabetes Chronic conditions Mental health Older people Public health Renal disease Women s health None identified Other: Relevant guidance NICE. Improving outcomes in urological cancers. NICE cancer service guidance, September NICE guideline in progress. Prostate cancer: diagnosis and treatment. Expected November Dec

3 Clinical need and burden of disease In 2002 there were 28,940 new cases of prostate cancer registered in England and Wales and in 2004 there were 9,166 deaths 2. An estimated 1,734,000 men with no prior diagnosis of prostate cancer have PSA tests in England and Wales per year 3. Existing comparators and treatments There are four main ways to investigate men with signs and symptoms suggestive of prostate cancer 4 : A Digital Rectal Examination (DRE) good for finding advanced cancers, but overall it can detect less than half of prostate cancers. The Prostate Specific Antigen (PSA) test this blood test measures the levels of PSA. Men with prostate cancer tend to have more PSA in their blood. The PSA test is not a foolproof test for prostate cancer. For every 100 men with a raised PSA level, only about 30 will have cancer cells in their prostate. Occasionally the PSA may read normal when cancer is present. Trans-Rectal Ultrasound Scan (TRUS) this type of scan is used to measure the size and density of the prostate. A Transrectal Needle Biopsy of the prostate this biopsy is usually done at the same time as an ultrasound. Efficacy and safety Trial name or code DD3PCA3 RNA Analysis in Urine 5 Prior to biopsy UPM3 6 Prior to biopsy Sponsor DiagnoCure DiagnoCure Status Published Published Participants in trial n=201 (158 analysed) undergoing transrectal ultrasound-guided biopsy. Urine sample collected after DRE but before biopsy. n=517 (443 analysed) undergoing transrectal ultrasound-guided biopsy. Urine sample collected after DRE but before biopsy. Primary outcome Analytic and clinical validity Analytic and clinical validity Key results 37% of men were positive for prostate cancer on biopsy. 79% of urine samples had sufficient PSA mrna (adequacy rate). 34% of men were positive for prostate cancer on biopsy. 86% of urine samples had sufficient PSA mrna (adequacy rate). PCA3 test sensitivity 82%, specificity 76%, positive predictive value(ppv) 67%, negative predictive value (NPV) 87%. Serum PSA test sensitivity 98%, specificity 5%, PPV 40%, and NPV 83%. The area under the ROC curve was 0.87 (95%CI 0.81 to 0.92). Likelihood ratio for positive test = 3.4. PCA3 test sensitivity 66% specificity 89%, PPV 75%, NPV 84%. Serum PSA test PPV 38%, NPV was 89% for a PSA cut-off of 2.5ng/mL and 80% for a PSA cut-off of 4.0ng/mL. The area under the ROC curve was 0.86 (95%CI 0.82 to 0.89). Likelihood ratio for positive test = 6. Trial name or code Ratio PCA3:PSA vs. PCA3 alone 7 APTIMA PCA3 Molecular Urine Test 1 PCA3 molecular urine assay 8 Sponsor Gen-Probe; DiagnoCure Gen-Probe Gen-Probe; DiagnoCure Status Poster Published Poster Dec

4 Participants in trial Primary outcome Key results n=150: scheduled for biopsy (n=93) or radical prostatectomy (n=26). Control group (n=31) radical prostatectomy 1 or more years earlier. Urine sample collected after DRE. n=143: scheduled for prostate biopsy (n=70), healthy men (n=52), or men who have undergone radical prostatectomy (n=21). Urine sample collected after DRE. National Horizon Scanning Centre n=564: scheduled for prostate biopsy (n=465), or scheduled for prostatectomy (n=26). Controls: men with no known prostate cancer risk (n=52) and men who had undergone radical prostatectomy (n=21). Urine sample collected after DRE. Analytic validity Analytic validity Analytic validity 45% of men were positive for prostate cancer on biopsy. Best correlation with biopsy from PCA3: PSA mrna ratio. PCA3 test sensitivity 66%, specificity 75%. Area under ROC curve Serum PSA sensitivity 89%, specificity 19%. 98% of urine samples had sufficient PSA mrna (adequacy rate). PCA3 test pre-biopsy - sensitivity 69%, specificity 79%. Area under ROC curve 0.75 (95% CI 0.57 to 0.92). Serum PSA specificity 28%. PCA3 test postprostatectomy men - negative except 1 with recurrence. 96% of urine samples had sufficient PSA mrna (adequacy rate). Mean PCA3:PSA ratios for normal (presumed disease free), biopsy negative, prostatic intraepithelial neoplasia (PIN), atypical small acinar proliferation (ASAP) and biopsy positive groups were significantly different (p<0.01). Higher PCA3/PSA ratios correlated with a higher probability of positive biopsy. Trial name or code PCA3 in 1 st or 1 or more prior negative biopsies 9 APTIMA PCA3 Molecular Urine Test 10 Sponsor Gen-probe; DiagnoCure GenProbe; Diagnocure Status Poster Poster Participants in trial n=448: scheduled for prostate biopsy, (n=430) or prostatectomy (n=18). 223 men were having their 1 st biopsy; 225 had had at least 1 prior negative biopsy. Urine sample collected after DRE. n=488: men scheduled for biopsy (n=426), scheduled for radical prostatectomy (n=62). Urine sample collected after DRE. Primary outcome Analytic and clinical validity Analytic validity Key results Pre 1 st biopsy group - PCA3 test sensitivity 53%; specificity 72%. The area under ROC curve Serum PSA assay AUC Prior negative biopsy group PCA3 sensitivity 58%; specificity 74%. Odds Ratio 3.9; area under ROC curve Serum PSA assay Odds Ratio 1.2; area under ROC curve Difference between PCA3 and serum PSA assay AUC significantly different p= % of men were positive for prostate cancer on biopsy. Centre 1 PCA3 test specificity 76%; sensitivity 50%; area under ROC curve (95% CI 0.63 to 0.73). Serum PSA test specificity 22%. Centre 2 PCA3 specificity 91%, sensitivity 60%. Area under ROC curve Serum PSA test specificity 50%. Dec

5 Estimated cost and cost impact The tests currently offered by MediLab and the Doctor s Laboratory cost between per test including administration costs. Serum PSA testing costs up to Potential or intended impact speculative Patients Reduced morbidity Quicker or more accurate diagnosis Reduced mortality or increased survival Earlier identification of disease Improved quality of life for patients and/or carers Other: Potential reduction of repeat biopsies. Services Increased use e.g. length of stay, Service reorganisation required out-patient visits Decreased use: reduction in biopsies or second Other: negative biopsies Staff or training required Costs Increased unit cost compared to alternative New costs: Increased costs: more patients coming for treatment Savings: Potential reduction in prostate biopsies and repeat PSA testing. Increased costs: capital investment needed Other: References 1 Groskopf et al. APTIMA PCA3 Molecular Urine Test: Development of a Method to Aid in the Diagnosis of Prostate Cancer. Clinical Chemistry 2006; 52 (6): Cancer Research UK. Cancer Stats Prostate Cancer UK. 3 Cancer Screening Programmes. Prostate specific antigen (PSA) tests. accessed 03/10/06. 4 CancerBACUP website accessed 23/2/05. 5 Tinzl M, Marberger M, Horvarth S, Chypre C. DD3 PCA3 RNA Analysis in Urine- A New Perspective for Detecting Prostate Cancer. European Urology 2004; 46: Fradet Y et al. upm3, a New Molecular Urine Test for the Detection of Prostate Cancer. Urology 2004; 64: Brentano S. et al. The Ratio of PCA3 to PSA mrnas in Urine is a Better Predictor of Prostate Biopsy Results than the Absolute Copy Level of PCA3 mrna Alone. American Association for Cancer Research Conference, 2005 Poster Groskopf et al. PCA3 Molecular Urine Assay: Characterization of a Method to Aid in the Diagnosis of Prostate Cancer, European Association of Urology, 2006 Poster. 9 Fradet Y et al. Performance of the PCA3 Urine Test on Subjects with Previous Negative Prostate Biopsies. European Association of Urology, 2006 Poster. 10 Groskopf et al. APTIMA PCA3 Molecular Urine Test: Development of a method to aid in the diagnosis of prostate cancer. 6 th International Congress on New Developments in Prostate Cancer and Prostate Disease, 2005 Poster. 11 Ryan A, Wilson S, Greenfield S et al. Range of self-tests available to buy in the United Kingdom: an Internet survey. Journal of Public Health 2006;28(4): Dec

6 The National Horizon Scanning Centre is funded by the Research and Development Division of the Department of Health, England The National Horizon Scanning Centre, Department of Public Health and Epidemiology University of Birmingham, Edgbaston, Birmingham, B15 2TT, England Tel: +44 (0) Fax +44 (0) Dec

Horizon Scanning Technology Briefing. Magnetic resonance spectroscopy for prostate cancer. National Horizon Scanning Centre.

Horizon Scanning Technology Briefing. Magnetic resonance spectroscopy for prostate cancer. National Horizon Scanning Centre. Horizon Scanning Technology Briefing National Horizon Scanning Centre Magnetic resonance spectroscopy for prostate cancer August 2006 This technology briefing is based on information available at the time

More information

Horizon Scanning Technology Briefing. Cetuximab (Erbitux) for metastatic colorectal cancer. National Horizon Scanning Centre.

Horizon Scanning Technology Briefing. Cetuximab (Erbitux) for metastatic colorectal cancer. National Horizon Scanning Centre. Horizon Scanning Technology Briefing National Horizon Scanning Centre Cetuximab (Erbitux) for metastatic colorectal cancer December 2006 This technology summary is based on information available at the

More information

Horizon Scanning Technology Briefing. Alvimopan (Entrareg ) for opioid-induced bowel disfunction. National Horizon Scanning Centre.

Horizon Scanning Technology Briefing. Alvimopan (Entrareg ) for opioid-induced bowel disfunction. National Horizon Scanning Centre. Horizon Scanning Technology Briefing National Horizon Scanning Centre Alvimopan (Entrareg ) for opioid-induced bowel disfunction August 2006 This technology briefing is based on information available at

More information

Horizon Scanning Technology Summary. Cyanocobalamin nasal spray (Nascobal) for vitamin B12 deficiency. National Horizon Scanning Centre.

Horizon Scanning Technology Summary. Cyanocobalamin nasal spray (Nascobal) for vitamin B12 deficiency. National Horizon Scanning Centre. Horizon Scanning Technology Summary National Horizon Scanning Centre Cyanocobalamin nasal spray (Nascobal) for vitamin B12 deficiency April 2007 This technology summary is based on information available

More information

Cabazitaxel (XRP-6258) for hormone refractory, metastatic prostate cancer second line after docetaxel

Cabazitaxel (XRP-6258) for hormone refractory, metastatic prostate cancer second line after docetaxel Cabazitaxel (XRP-6258) for hormone refractory, metastatic prostate cancer second line after docetaxel April 2009 This technology summary is based on information available at the time of research and a

More information

Horizon Scanning Technology Briefing. Sutent (Sunitinib) for first-line and adjuvant treatment of renal cell carcinoma

Horizon Scanning Technology Briefing. Sutent (Sunitinib) for first-line and adjuvant treatment of renal cell carcinoma Horizon Scanning Technology Briefing National Horizon Scanning Centre Sutent (Sunitinib) for first-line and adjuvant treatment of renal cell carcinoma August 2006: Updated October 2006 This technology

More information

National Horizon Scanning Centre. Aflibercept (VEGF Trap) for advanced chemo-refractory epithelial ovarian cancer. December 2007

National Horizon Scanning Centre. Aflibercept (VEGF Trap) for advanced chemo-refractory epithelial ovarian cancer. December 2007 Aflibercept (VEGF Trap) for advanced chemo-refractory epithelial ovarian cancer December 2007 This technology summary is based on information available at the time of research and a limited literature

More information

National Horizon Scanning Centre. Vandetanib (Zactima) for locally advanced or metastatic medullary thyroid cancer. December 2007

National Horizon Scanning Centre. Vandetanib (Zactima) for locally advanced or metastatic medullary thyroid cancer. December 2007 Vandetanib (Zactima) for locally advanced or metastatic medullary thyroid cancer December 2007 This technology summary is based on information available at the time of research and a limited literature

More information

Horizon Scanning Technology Summary. Temozolomide (Temodal) for advanced metastatic melanoma. National Horizon Scanning Centre.

Horizon Scanning Technology Summary. Temozolomide (Temodal) for advanced metastatic melanoma. National Horizon Scanning Centre. Horizon Scanning Technology Summary National Horizon Scanning Centre Temozolomide (Temodal) for advanced metastatic melanoma April 2007 This technology summary is based on information available at the

More information

National Horizon Scanning Centre. Bevacizumab (Avastin) in combination with non-taxanes for metastatic breast cancer - first line therapy

National Horizon Scanning Centre. Bevacizumab (Avastin) in combination with non-taxanes for metastatic breast cancer - first line therapy Bevacizumab (Avastin) in combination with non-taxanes for metastatic breast cancer - first line therapy December 2007 This technology summary is based on information available at the time of research and

More information

National Horizon Scanning Centre. Erlotinib (Tarceva) in combination with bevacizumab for advanced or metastatic non-small cell lung cancer

National Horizon Scanning Centre. Erlotinib (Tarceva) in combination with bevacizumab for advanced or metastatic non-small cell lung cancer Erlotinib (Tarceva) in combination with bevacizumab for advanced or metastatic non-small cell lung cancer This technology summary is based on information available at the time of research and a limited

More information

National Horizon Scanning Centre. Ampligen for chronic fatigue syndrome. December 2007

National Horizon Scanning Centre. Ampligen for chronic fatigue syndrome. December 2007 Ampligen for chronic fatigue syndrome December 2007 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive

More information

Horizon Scanning Technology Summary. Tenofovir disoproxil fumarate for hepatitis B. National Horizon Scanning Centre. April 2007

Horizon Scanning Technology Summary. Tenofovir disoproxil fumarate for hepatitis B. National Horizon Scanning Centre. April 2007 Horizon Scanning Technology Summary National Horizon Scanning Centre Tenofovir disoproxil fumarate for hepatitis B April 2007 This technology summary is based on information available at the time of research

More information

National Horizon Scanning Centre. Temsirolimus (Torisel) for mantle cell lymphoma - relapsed and/or refractory. January 2008

National Horizon Scanning Centre. Temsirolimus (Torisel) for mantle cell lymphoma - relapsed and/or refractory. January 2008 Temsirolimus (Torisel) for mantle cell lymphoma - relapsed and/or refractory January 2008 This technology summary is based on information available at the time of research and a limited literature search.

More information

National Horizon Scanning Centre. Rituximab (MabThera) for chronic lymphocytic leukaemia. September 2007

National Horizon Scanning Centre. Rituximab (MabThera) for chronic lymphocytic leukaemia. September 2007 Rituximab (MabThera) for chronic lymphocytic leukaemia This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive

More information

Horizon Scanning Technology Summary. Methylnaltrexone for opioid induced constipation in advanced illness and palliative care

Horizon Scanning Technology Summary. Methylnaltrexone for opioid induced constipation in advanced illness and palliative care Horizon Scanning Technology Summary National Horizon Scanning Centre Methylnaltrexone for opioid induced constipation in advanced illness and palliative care April 2007 This technology summary is based

More information

National Horizon Scanning Centre. Azacitidine (Vidaza) for myelodysplastic syndrome. September 2007

National Horizon Scanning Centre. Azacitidine (Vidaza) for myelodysplastic syndrome. September 2007 Azacitidine (Vidaza) for myelodysplastic syndrome September 2007 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to

More information

Horizon Scanning Technology Briefing National Helical Tomotherapy Horizon Hi-ART System for Scanning external cancer Centre radiotherapy August 2006

Horizon Scanning Technology Briefing National Helical Tomotherapy Horizon Hi-ART System for Scanning external cancer Centre radiotherapy August 2006 Horizon Scanning Technology Briefing National Horizon Scanning Centre Helical Tomotherapy Hi-ART System for external cancer radiotherapy August 2006 This technology briefing is based on information available

More information

National Horizon Scanning Centre. Sunitinib (Sutent) for advanced and/or metastatic breast cancer. December 2007

National Horizon Scanning Centre. Sunitinib (Sutent) for advanced and/or metastatic breast cancer. December 2007 Sunitinib (Sutent) for advanced and/or metastatic breast cancer December 2007 This technology summary is based on information available at the time of research and a limited literature search. It is not

More information

Horizon Scanning Technology Briefing. Zoledronic Acid (Aclasta) once yearly treatment for postmenopausal. National Horizon Scanning Centre

Horizon Scanning Technology Briefing. Zoledronic Acid (Aclasta) once yearly treatment for postmenopausal. National Horizon Scanning Centre Horizon Scanning Technology Briefing National Horizon Scanning Centre Zoledronic Acid (Aclasta) once yearly treatment for postmenopausal osteoporosis December 2006 This technology summary is based on information

More information

AVOID A POTENTIALLY UNNECESSARY REPEAT PROSTATE BIOPSY. The Progensa PCA3 test

AVOID A POTENTIALLY UNNECESSARY REPEAT PROSTATE BIOPSY. The Progensa PCA3 test AVOID A POTENTIALLY UNNECESSARY REPEAT PROSTATE BIOPSY The Progensa PCA3 test is the first FDA-approved prostate cancer-specific test of its kind that helps you and your doctor decide if a repeat biopsy

More information

Horizon Scanning Technology Summary. Liraglutide for type 2 diabetes. National Horizon Scanning Centre. April 2007

Horizon Scanning Technology Summary. Liraglutide for type 2 diabetes. National Horizon Scanning Centre. April 2007 Horizon Scanning Technology Summary National Horizon Scanning Centre Liraglutide for type 2 diabetes April 2007 This technology summary is based on information available at the time of research and a limited

More information

Horizon Scanning Technology Summary. Abatacept (Orencia) for juvenile idiopathic arthritis. National Horizon Scanning Centre.

Horizon Scanning Technology Summary. Abatacept (Orencia) for juvenile idiopathic arthritis. National Horizon Scanning Centre. Horizon Scanning Technology Summary National Horizon Scanning Centre Abatacept (Orencia) for juvenile idiopathic arthritis June 2007 This technology summary is based on information available at the time

More information

Horizon Scanning Technology Summary. Magnetic resonance angiography (MRA) imaging for the detection of coronary artery disease

Horizon Scanning Technology Summary. Magnetic resonance angiography (MRA) imaging for the detection of coronary artery disease Horizon Scanning Technology Summary National Horizon Scanning Centre Magnetic resonance angiography (MRA) imaging for the detection of coronary artery disease April 2007 This technology summary is based

More information

Horizon Scanning Technology Summary. Adalimumab (Humira) for juvenile idiopathic arthritis. National Horizon Scanning Centre.

Horizon Scanning Technology Summary. Adalimumab (Humira) for juvenile idiopathic arthritis. National Horizon Scanning Centre. Horizon Scanning Technology Summary National Horizon Scanning Centre Adalimumab (Humira) for juvenile idiopathic arthritis June 2007 This technology summary is based on information available at the time

More information

Predicting Prostate Biopsy Outcome Using a PCA3-based Nomogram in a Polish Cohort

Predicting Prostate Biopsy Outcome Using a PCA3-based Nomogram in a Polish Cohort Predicting Prostate Biopsy Outcome Using a PCA3-based Nomogram in a Polish Cohort MACIEJ SALAGIERSKI 1, PETER MULDERS 2 and JACK A. SCHALKEN 2 1 Urology Department, Medical University of Łódź, Poland;

More information

MAKE REPEAT PROSTATE BIOPSY DECISIONS WITH CONFIDENCE. The Progensa PCA3 test

MAKE REPEAT PROSTATE BIOPSY DECISIONS WITH CONFIDENCE. The Progensa PCA3 test MAKE REPEAT PROSTATE BIOPSY DECISIONS WITH CONFIDENCE The Progensa PCA3 test is the first FDA-approved prostate cancer-specific test of its kind that gives you the information you need to determine if

More information

National Horizon Scanning Centre. Dronedarone (Multaq) for atrial fibrillation and atrial flutter. December 2007

National Horizon Scanning Centre. Dronedarone (Multaq) for atrial fibrillation and atrial flutter. December 2007 Dronedarone (Multaq) for atrial fibrillation and atrial flutter December 2007 This technology summary is based on information available at the time of research and a limited literature search. It is not

More information

National Horizon Scanning Centre. GV1001 for advanced and/or metastatic pancreatic cancer. April 2008

National Horizon Scanning Centre. GV1001 for advanced and/or metastatic pancreatic cancer. April 2008 GV1001 for advanced and/or metastatic pancreatic cancer April 2008 This technology summary is based on information available at the time of research and a limited literature search. It is not intended

More information

Towards Early and More Specific Diagnosis of Prostate Cancer? Beyond PSA: New Biomarkers Ready for Prime Time

Towards Early and More Specific Diagnosis of Prostate Cancer? Beyond PSA: New Biomarkers Ready for Prime Time european urology supplements 8 (2009) 97 102 available at www.sciencedirect.com journal homepage: www.europeanurology.com Towards Early and More Specific Diagnosis of Prostate Cancer? Beyond PSA: New Biomarkers

More information

Eribulin for locally advanced or metastatic breast cancer third line; monotherapy

Eribulin for locally advanced or metastatic breast cancer third line; monotherapy Eribulin for locally advanced or metastatic breast cancer third line; monotherapy April 2009 This technology summary is based on information available at the time of research and a limited literature search.

More information

National Horizon Scanning Centre. Pregabalin (Lyrica) for fibromyalgia. September 2007

National Horizon Scanning Centre. Pregabalin (Lyrica) for fibromyalgia. September 2007 Pregabalin (Lyrica) for fibromyalgia September 2007 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive

More information

One Stop Prostate Biopsy Protocol Author Consultation Date Approved

One Stop Prostate Biopsy Protocol Author Consultation Date Approved One Stop Prostate Biopsy Protocol Author Consultation Date Approved Urology Nurse Practioner PROTOCOL FOR MEN ATTENDING A ONE STOP PROSTATE BIOPSY CLINIC RATIONALE Prostate cancer is the most common cancer

More information

Rational Approach to Implementation of Prostate Cancer Antigen 3 Into Clinical Care

Rational Approach to Implementation of Prostate Cancer Antigen 3 Into Clinical Care Rational Approach to Implementation of Prostate Cancer Antigen 3 Into Clinical Care Rou Wang, MD 1 ; Arul M. Chinnaiyan, MD 1,2,3 ; Rodney L. Dunn, MS 1 ; Kirk J. Wojno, MD 2 ; and John T. Wei, MD, MS

More information

National Horizon Scanning Centre. Tadalafil for pulmonary arterial hypertension. October 2007

National Horizon Scanning Centre. Tadalafil for pulmonary arterial hypertension. October 2007 Tadalafil for pulmonary arterial hypertension October 2007 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a

More information

Erlotinib (Tarceva) for non small cell lung cancer advanced or metastatic maintenance monotherapy

Erlotinib (Tarceva) for non small cell lung cancer advanced or metastatic maintenance monotherapy Erlotinib (Tarceva) for non small cell lung cancer advanced or metastatic maintenance monotherapy September 2008 This technology summary is based on information available at the time of research and a

More information

Cryotherapy for recurrent prostate cancer. Issue date: May 2005

Cryotherapy for recurrent prostate cancer. Issue date: May 2005 Issue date: May 2005 Cryotherapy for recurrent Understanding NICE guidance information for people considering the procedure, and for the public Information about NICE Interventional Procedure Guidance

More information

Insulin degludec/insulin aspart (DegludecPlus) for type 1 diabetes

Insulin degludec/insulin aspart (DegludecPlus) for type 1 diabetes Insulin degludec/insulin aspart (DegludecPlus) for type 1 diabetes This technology summary is based on information available at the time of research and a limited literature search. It is not intended

More information

National Horizon Scanning Centre. Irbesartan (Aprovel) for heart failure with preserved systolic function. August 2008

National Horizon Scanning Centre. Irbesartan (Aprovel) for heart failure with preserved systolic function. August 2008 Irbesartan (Aprovel) for heart failure with preserved systolic function August 2008 This technology summary is based on information available at the time of research and a limited literature search. It

More information

National Horizon Scanning Centre. Enhanced Liver Fibrosis Test (ELF) for evaluating liver fibrosis. June 2008

National Horizon Scanning Centre. Enhanced Liver Fibrosis Test (ELF) for evaluating liver fibrosis. June 2008 Enhanced Liver Fibrosis Test (ELF) for evaluating liver fibrosis June 2008 This technology summary is based on information available at the time of research and a limited literature search. It is not intended

More information

National Horizon Scanning Centre. Bevacizumab (Avastin) for glioblastoma multiforme - relapsed. August 2008

National Horizon Scanning Centre. Bevacizumab (Avastin) for glioblastoma multiforme - relapsed. August 2008 Bevacizumab (Avastin) for glioblastoma multiforme - relapsed August 2008 This technology summary is based on information available at the time of research and a limited literature search. It is not intended

More information

Rilonacept for cryopyrin associated periodic syndromes

Rilonacept for cryopyrin associated periodic syndromes Rilonacept for cryopyrin associated periodic syndromes August 2009 This technology summary is based on information available at the time of research and a limited literature search. It is not intended

More information

National Horizon Scanning Centre. Decitabine (Dacogen) for myelodysplastic syndrome. April 2008

National Horizon Scanning Centre. Decitabine (Dacogen) for myelodysplastic syndrome. April 2008 Decitabine (Dacogen) for myelodysplastic syndrome April 2008 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be

More information

Insulin glulisine (Apidra) for type 1 diabetes mellitus in adolescents and children

Insulin glulisine (Apidra) for type 1 diabetes mellitus in adolescents and children Insulin glulisine (Apidra) for type 1 diabetes mellitus in adolescents and children December 2008 This technology summary is based on information available at the time of research and a limited literature

More information

National Horizon Scanning Centre. Methylnaltrexone (MOA-728) for postoperative ileus. April 2008

National Horizon Scanning Centre. Methylnaltrexone (MOA-728) for postoperative ileus. April 2008 (MOA-728) for postoperative ileus April 2008 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive statement

More information

National Horizon Scanning Centre. Ipilimumab (MDX-010) for unresectable stage III or IV metastatic melanoma - first or second line treatment

National Horizon Scanning Centre. Ipilimumab (MDX-010) for unresectable stage III or IV metastatic melanoma - first or second line treatment Ipilimumab (MDX-010) for unresectable stage III or IV metastatic melanoma - first or second line treatment April 2008 This technology summary is based on information available at the time of research and

More information

MEDICAL POLICY Genetic and Protein Biomarkers for Diagnosis and Risk Assessment of

MEDICAL POLICY Genetic and Protein Biomarkers for Diagnosis and Risk Assessment of POLICY: PG0367 ORIGINAL EFFECTIVE: 08/26/16 LAST REVIEW: 09/27/18 MEDICAL POLICY Genetic and Protein Biomarkers for Diagnosis and Risk Assessment of Prostate Cancer GUIDELINES This policy does not certify

More information

National Horizon Scanning Centre. Saxagliptin (BMS ) for type 2 diabetes. April 2008

National Horizon Scanning Centre. Saxagliptin (BMS ) for type 2 diabetes. April 2008 Saxagliptin (BMS 477118) for type 2 diabetes This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive statement

More information

Denosumab (AMG 162) for bone metastases from solid tumours and multiple myeloma

Denosumab (AMG 162) for bone metastases from solid tumours and multiple myeloma Denosumab (AMG 162) for bone metastases from solid tumours and multiple myeloma September 2008 This technology summary is based on information available at the time of research and a limited literature

More information

Cilengitide (Impetreve) for glioblastoma multiforme. February 2012

Cilengitide (Impetreve) for glioblastoma multiforme. February 2012 Cilengitide (Impetreve) for glioblastoma multiforme February 2012 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to

More information

DIAGNOSTICS ASSESSMENT PROGRAMME

DIAGNOSTICS ASSESSMENT PROGRAMME DIAGNOSTICS ASSESSMENT PROGRAMME Evidence overview Diagnosis and monitoring of prostate cancer: PROGENSA PCA3 assay and the Prostate Health Index (PHI) This overview summarises the key issues for the Diagnostics

More information

BJUI. Follow-up of men with an elevated PCA3 score and a negative biopsy: does an elevated PCA3 score indeed predict the presence of prostate cancer?

BJUI. Follow-up of men with an elevated PCA3 score and a negative biopsy: does an elevated PCA3 score indeed predict the presence of prostate cancer? . JOURNAL COMPILATION 2010 BJU INTERNATIONAL Urological Oncology FOLLOW-UP OF MEN WITH AN ELEVATED PCA3 SCORE AND A NEGATIVE BIOPSY REMZI ET AL. BJUI BJU INTERNATIONAL Follow-up of men with an elevated

More information

National Horizon Scanning Centre. Mannitol dry powder for inhalation (Bronchitol) for cystic fibrosis. April 2008

National Horizon Scanning Centre. Mannitol dry powder for inhalation (Bronchitol) for cystic fibrosis. April 2008 Mannitol dry powder for inhalation (Bronchitol) for cystic fibrosis April 2008 This technology summary is based on information available at the time of research and a limited literature search. It is not

More information

Olesoxime for amyotrophic lateral sclerosis first line

Olesoxime for amyotrophic lateral sclerosis first line Olesoxime for amyotrophic lateral sclerosis first line May 2011 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to

More information

National Horizon Scanning Centre. Irbesartan (Aprovel) for prevention of cardiovascular complications in patients with persistent atrial fibrillation

National Horizon Scanning Centre. Irbesartan (Aprovel) for prevention of cardiovascular complications in patients with persistent atrial fibrillation Irbesartan (Aprovel) for prevention of cardiovascular complications in patients with persistent atrial fibrillation August 2008 This technology summary is based on information available at the time of

More information

Diagnostics guidance Published: 3 June 2015 nice.org.uk/guidance/dg17

Diagnostics guidance Published: 3 June 2015 nice.org.uk/guidance/dg17 Diagnosing prostate cancer: PROGENSA PCA3 assay and Prostate Health Index Diagnostics guidance Published: 3 June 2015 nice.org.uk/guidance/dg17 NICE 2018. All rights reserved. Subject to Notice of rights

More information

Liraglutide (Victoza) in combination with basal insulin for type 2 diabetes

Liraglutide (Victoza) in combination with basal insulin for type 2 diabetes Liraglutide (Victoza) in combination with basal insulin for type 2 diabetes May 2011 This technology summary is based on information available at the time of research and a limited literature search. It

More information

National Horizon Scanning Centre. Imatinib (Glivec) for adjuvant therapy in gastrointestinal stromal tumours. August 2008

National Horizon Scanning Centre. Imatinib (Glivec) for adjuvant therapy in gastrointestinal stromal tumours. August 2008 Imatinib (Glivec) for adjuvant therapy in gastrointestinal stromal tumours August 2008 This technology summary is based on information available at the time of research and a limited literature search.

More information

10/2/2018 OBJECTIVES PROSTATE HEALTH BACKGROUND THE PROSTATE HEALTH INDEX PHI*: BETTER PROSTATE CANCER DETECTION

10/2/2018 OBJECTIVES PROSTATE HEALTH BACKGROUND THE PROSTATE HEALTH INDEX PHI*: BETTER PROSTATE CANCER DETECTION THE PROSTATE HEALTH INDEX PHI*: BETTER PROSTATE CANCER DETECTION Lenette Walters, MS, MT(ASCP) Medical Affairs Manager Beckman Coulter, Inc. *phi is a calculation using the values from PSA, fpsa and p2psa

More information

B-cell lymphoma vaccine (BiovaxID) for follicular non-hodgkin s lymphoma

B-cell lymphoma vaccine (BiovaxID) for follicular non-hodgkin s lymphoma B-cell lymphoma vaccine (BiovaxID) for follicular non-hodgkin s lymphoma May 2010 This technology summary is based on information available at the time of research and a limited literature search. It is

More information

The use of PCA3 in the diagnosis of prostate cancer

The use of PCA3 in the diagnosis of prostate cancer The use of PCA3 in the diagnosis of prostate cancer Daphne Hessels and Jack A. Schalken Abstract Although the routine use of serum PsA testing has undoubtedly increased prostate cancer detection, one of

More information

Cabozantinib for medullary thyroid cancer. February 2012

Cabozantinib for medullary thyroid cancer. February 2012 Cabozantinib for medullary thyroid cancer February 2012 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive

More information

Clinical Utility of the PCA3 Urine Assay in European Men Scheduled for Repeat Biopsy

Clinical Utility of the PCA3 Urine Assay in European Men Scheduled for Repeat Biopsy european urology 54 (2008) 1081 1088 available at www.sciencedirect.com journal homepage: www.europeanurology.com Prostate Cancer Clinical Utility of the PCA3 Urine Assay in European Men Scheduled for

More information

MR-US Fusion Guided Biopsy: Is it fulfilling expectations?

MR-US Fusion Guided Biopsy: Is it fulfilling expectations? MR-US Fusion Guided Biopsy: Is it fulfilling expectations? Kenneth L. Gage MD, PhD Assistant Member Department of Diagnostic Imaging and Interventional Radiology 4 th Annual New Frontiers in Urologic Oncology

More information

Everolimus (Votubia) for angiomyolipoma associated with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis first line or post surgery

Everolimus (Votubia) for angiomyolipoma associated with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis first line or post surgery Everolimus (Votubia) for angiomyolipoma associated with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis first line or post surgery April 2011 This technology summary is based on information

More information

National Horizon Scanning Centre. Oral and inhaled treprostinil for pulmonary arterial hypertension: NYHA class III. April 2008

National Horizon Scanning Centre. Oral and inhaled treprostinil for pulmonary arterial hypertension: NYHA class III. April 2008 Oral and inhaled treprostinil for pulmonary arterial hypertension: NYHA class April 2008 This technology summary is based on information available at the time of research and a limited literature search.

More information

NIH Public Access Author Manuscript Cancer. Author manuscript; available in PMC 2010 March 1.

NIH Public Access Author Manuscript Cancer. Author manuscript; available in PMC 2010 March 1. NIH Public Access Author Manuscript Published in final edited form as: Cancer. 2009 September 1; 115(17): 3879 3886. doi:10.1002/cncr.24447. Rational Approach to Implementation of PCA3 into Clinical Care

More information

Roflumilast (Daxas) for chronic obstructive pulmonary disease

Roflumilast (Daxas) for chronic obstructive pulmonary disease Roflumilast (Daxas) for chronic obstructive pulmonary disease August 2009 This technology summary is based on information available at the time of research and a limited literature search. It is not intended

More information

Urine Biomarkers for Prostate Cancer Detection

Urine Biomarkers for Prostate Cancer Detection Urine Biomarkers for Prostate Cancer Detection Dr. Qun Lu Professor of Anatomy and Cell Biology Director, The Wooten Laboratory Brody School of Medicine Acknowledgement of Support Funding US National Institutes

More information

Ustekinumab (Stelara) for psoriatic arthritis second line after disease modifying anti rheumatic drugs (DMARDs)

Ustekinumab (Stelara) for psoriatic arthritis second line after disease modifying anti rheumatic drugs (DMARDs) Ustekinumab (Stelara) for psoriatic arthritis second line after disease modifying anti rheumatic drugs (DMARDs) January 2010 This technology summary is based on information available at the time of research

More information

Abatacept (Orencia) for active rheumatoid arthritis. August 2009

Abatacept (Orencia) for active rheumatoid arthritis. August 2009 Abatacept (Orencia) for active rheumatoid arthritis August 2009 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to

More information

ADVICE TO PATIENTS REQUESTING PSA MEASUREMENT

ADVICE TO PATIENTS REQUESTING PSA MEASUREMENT Frequently-Asked Questions What is the aim of this leaflet? Prostate cancer is a serious condition. The PSA test, which can give an early indication of prostate cancer, is available to you if you want

More information

National Horizon Scanning Centre. Transient elastography (FibroScan) for evaluating liver fibrosis. April 2008

National Horizon Scanning Centre. Transient elastography (FibroScan) for evaluating liver fibrosis. April 2008 Transient elastography (FibroScan) for evaluating liver fibrosis April 2008 This technology summary is based on information available at the time of research and a limited literature search. It is not

More information

..biomarkers, running the gauntlet..

..biomarkers, running the gauntlet.. The long and winding round for the clinical introduction of a biomarker Molecular diagnostic of prostate cancer based on non invasive liquid biopsies..biomarkers, running the gauntlet.. Prof dr Jack A

More information

Afamelanotide for erythropoietic protoporphyria and congenital erythropoietic porphyria

Afamelanotide for erythropoietic protoporphyria and congenital erythropoietic porphyria Afamelanotide for erythropoietic protoporphyria and congenital erythropoietic porphyria This technology summary is based on information available at the time of research and a limited literature search.

More information

Certolizumab pegol (Cimzia) for psoriatic arthritis second line

Certolizumab pegol (Cimzia) for psoriatic arthritis second line Certolizumab pegol (Cimzia) for psoriatic arthritis second line This technology summary is based on information available at the time of research and a limited literature search. It is not intended to

More information

Cancer. Description. Section: Surgery Effective Date: October 15, 2016 Subsection: Original Policy Date: September 9, 2011 Subject:

Cancer. Description. Section: Surgery Effective Date: October 15, 2016 Subsection: Original Policy Date: September 9, 2011 Subject: Subject: Saturation Biopsy for Diagnosis, Last Review Status/Date: September 2016 Page: 1 of 9 Saturation Biopsy for Diagnosis, Description Saturation biopsy of the prostate, in which more cores are obtained

More information

Lacosamide (Vimpat) for partial-onset epilepsy monotherapy. December 2011

Lacosamide (Vimpat) for partial-onset epilepsy monotherapy. December 2011 Lacosamide (Vimpat) for partial-onset epilepsy monotherapy This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a

More information

Date Modified: March 31, Clinical Quality Measures for PQRS

Date Modified: March 31, Clinical Quality Measures for PQRS Date Modified: March 31, 2015 2015 Clinical Quality s for PQRS # Domain Title Description Type Denominator Numerator Denominator Exclusions/Exceptions 1 Patient Safety Prostate Biopsy Antibiotic Process

More information

Prostate cancer smart screening, precision diagnosis, personalised treatment'

Prostate cancer smart screening, precision diagnosis, personalised treatment' Prostate cancer smart screening, precision diagnosis, personalised treatment' Prof. Hashim Ahmed PhD, FRCS(Urol), BM, BCh (Oxon), BA(Hons) Consultant Urological Surgeon Bupa Cromwell Hospital Clinics:

More information

Pasireotide Long-Acting Repeatable (Signifor) for acromegaly first and second line

Pasireotide Long-Acting Repeatable (Signifor) for acromegaly first and second line Pasireotide Long-Acting Repeatable (Signifor) for acromegaly first and second line December 2010 This technology summary is based on information available at the time of research and a limited literature

More information

ADVICE TO PATIENTS REQUESTING PSA MEASUREMENT FREQUENTLY-ASKED QUESTIONS

ADVICE TO PATIENTS REQUESTING PSA MEASUREMENT FREQUENTLY-ASKED QUESTIONS The British Association of Urological Surgeons 35-43 Lincoln s Inn Fields London WC2A 3PE Phone: Fax: Website: E-mail: +44 (0)20 7869 6950 +44 (0)20 7404 5048 www.baus.org.uk admin@baus.org.uk ADVICE TO

More information

Technology appraisal guidance Published: 21 November 2018 nice.org.uk/guidance/ta546

Technology appraisal guidance Published: 21 November 2018 nice.org.uk/guidance/ta546 Padeliporfin for untreated localised prostate cancer Technology appraisal guidance Published: 21 November 2018 nice.org.uk/guidance/ta546 NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-ofrights).

More information

David Gillatt Bristol Urological Institute. David Gillatt Bristol UK

David Gillatt Bristol Urological Institute. David Gillatt Bristol UK David Gillatt Bristol Urological Institute David Gillatt Bristol UK Prostate Problems The prostate grows with age - >80% men over 60 have benign enlargement As it grows it can obstruct the flow of urine

More information

External Validation of Urinary PCA3-Based Nomograms to Individually Predict Prostate Biopsy Outcome

External Validation of Urinary PCA3-Based Nomograms to Individually Predict Prostate Biopsy Outcome EUROPEAN UROLOGY 58 (2010) 727 732 available at www.sciencedirect.com journal homepage: www.europeanurology.com Prostate Cancer External Validation of Urinary PCA3-Based Nomograms to Individually Predict

More information

Genetic and Protein Biomarkers for the Diagnosis and Cancer Risk Assessment of Prostate Cancer

Genetic and Protein Biomarkers for the Diagnosis and Cancer Risk Assessment of Prostate Cancer Genetic and Protein Biomarkers for the Diagnosis and Cancer Risk Assessment of Prostate Cancer Policy Number: 2.04.33 Last Review: 7/2017 Origination: 7/2014 Next Review: 7/2018 Policy Blue Cross and Blue

More information

PSA and the Future. Axel Heidenreich, Department of Urology

PSA and the Future. Axel Heidenreich, Department of Urology PSA and the Future Axel Heidenreich, Department of Urology PSA and Prostate Cancer EAU Guideline 2011 PSA is a continuous variable PSA value (ng/ml) risk of PCa, % 0 0.5 6.6 0.6 1 10.1 1.1 2 17.0 2.1 3

More information

National Horizon Scanning Centre. Mepolizumab (Bosatria) for hypereosinophilic syndrome first line in combination with corticosteroids.

National Horizon Scanning Centre. Mepolizumab (Bosatria) for hypereosinophilic syndrome first line in combination with corticosteroids. Mepolizumab (Bosatria) for hypereosinophilic syndrome first line in combination with corticosteroids May 2008 This technology summary is based on information available at the time of research and a limited

More information

Having a transperineal prostate biopsy

Having a transperineal prostate biopsy Having a transperineal prostate biopsy This leaflet should help to answer some of your questions about having a transperineal prostate biopsy. If you have any further questions, please speak to a doctor

More information

Prostate MRI Hamidreza Abdi, MD,FEBU Post Doctoral Fellow Vancouver Prostate Centre UBC Department of Urologic Sciences May-20144

Prostate MRI Hamidreza Abdi, MD,FEBU Post Doctoral Fellow Vancouver Prostate Centre UBC Department of Urologic Sciences May-20144 Prostate MRI Hamidreza Abdi, MD,FEBU Post Doctoral Fellow Vancouver Prostate Centre UBC Department of Urologic Sciences May-20144 Objectives: Detection of prostate cancer the need for better imaging What

More information

Attending for your Prostate Scan

Attending for your Prostate Scan Attending for your Prostate Scan Patient Information The aim of this booklet is to give you enough information: To help you prepare for your hospital visit To give properly informed consent for the procedure

More information

Trans-rectal Ultrasound Scan and Biopsy (TRUSS)

Trans-rectal Ultrasound Scan and Biopsy (TRUSS) Trans-rectal Ultrasound Scan and Biopsy (TRUSS) What is the prostate gland? The prostate is a small gland the size of a walnut. It is found at the base of the bladder and surrounds the urethra (water pipe).

More information

NICE BULLETIN Diagnosis & treatment of prostate cancer

NICE BULLETIN Diagnosis & treatment of prostate cancer Diagnosis & treatment of prostate cancer NICE provided the content for this booklet which is independent of any company or product advertised Diagnosis and treatment of prostate cancer Introduction In

More information

How to detect and investigate Prostate Cancer before TRT

How to detect and investigate Prostate Cancer before TRT How to detect and investigate Prostate Cancer before TRT Frans M.J. Debruyne Professor of Urology Andros Men s Health Institutes, The Netherlands Bruges, 25-26 September 2014 PRISM Recommendations for

More information

Riociguat for chronic thromboembolic pulmonary hypertension

Riociguat for chronic thromboembolic pulmonary hypertension Riociguat for chronic thromboembolic pulmonary hypertension This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a

More information

Prostate Cancer. What Are the Risk Factors? Prostate cancer is the second leading cancer that causes death to men in the U.S.

Prostate Cancer. What Are the Risk Factors? Prostate cancer is the second leading cancer that causes death to men in the U.S. Prostate cancer is the second leading cancer that causes death to men in the U.S. What Are the Risk Factors? Prostate cancer is unusual because it does not behave the same way in all men. Sometimes the

More information

THE PROSTATE. SMALL GLAND BIG PROBLEM By John Crow. Chapter 4

THE PROSTATE. SMALL GLAND BIG PROBLEM By John Crow. Chapter 4 THE PROSTATE SMALL GLAND BIG PROBLEM By John Crow Chapter 4 In this chapter I want to address the big issue CANCER. What is CANCER? As you will already know, our body tissue is made up of literally Billions

More information

The European Board of Urology

The European Board of Urology Page 1 of 15 The European Board of Urology Sub-specialty certification application: Prostate cancer, A - General information A1 - APPLICATION IDENTIFICATION 1a. Application code blank 1b. EBU internal

More information

Contribution of prostate-specific antigen density in the prediction of prostate cancer: Does prostate volume matter?

Contribution of prostate-specific antigen density in the prediction of prostate cancer: Does prostate volume matter? ORIGINAL ARTICLE Gulhane Med J 2018;60: 14-18 Gülhane Faculty of Medicine 2018 doi: 10.26657/gulhane.00010 Contribution of prostate-specific antigen density in the prediction of prostate cancer: Does prostate

More information

Getting to Diagnosis. Debbie Victor Uro-Oncology CNS Royal Cornwall Hospitals Trust

Getting to Diagnosis. Debbie Victor Uro-Oncology CNS Royal Cornwall Hospitals Trust Getting to Diagnosis Debbie Victor Uro-Oncology CNS Royal Cornwall Hospitals Trust GP Visit Symptoms Reduced urinary flow Difficulty starting/stopping Urgency Frequency Nocturia Because a friend/relative

More information