Protocol. This trial protocol has been provided by the authors to give readers additional information about their work.
|
|
- Eleanore Charles
- 5 years ago
- Views:
Transcription
1 Protocol This trial protocol has been provided by the authors to give readers additional information about their work. Protocol for: Wilt TJ, Brawer MK, Jones KM, et al. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med 2012;367: DOI: /NEJMoa
2 May 9, 2012 Re: R3 Radical Prostatectomy Versus Observation for Localized Prostate Cancer "This supplement contains the following items: 1. Original protocol, final protocol, summary of changes. 2. Original statistical analysis plan, final statistical analysis plan, summary of changes" Sincerely and thank you, Timothy J. Wilt, M.D., MPH, Professor of Medicine Minneapolis VA Center for Chronic Disease Outcomes Research 1 Veterans Drive (111 0) Minneapolis, MN Phone: Fax: Tim.wilt@va.gov
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192
193
194
195
196
197
198
199
200
201
202
203
204
205
206
207
208
209
210
211
212
213
214
215
216
217
218
219
220
221
222
223
224
225
226
227
228
229
230
231
232
233
234
235
236
237
238
239
240
241
242
243
244
245
246
247
248
249
250
251
252
253
254
255
256
257
258
259
260
261
262
263
264
265
266
267
268
269
270
271
272
273
274
275
276
277
278
279
280
281
282
283
284
285
286
287
288
289
290
291
292
293
294
295
296
297
298
299
300
301
302
303
304
305
306
307
308
309
310
311
312
313 PIVOT Protocol Refinements and Updates for A priori Analyses Some Which will be incorportated into the Initial PIVOT Manuscripts 11/5/10 Intended for Writing Group Purposes Meeting Discussions: January 6 th and 8 th, 2010: Writing Group Members: Wilt, Brawer, Barry, Aronson, Wei, Jones, Culkin, Wheeler Manuscript #1: The Prostate cancer Intervention Versus Observation Trial (PIVOT): a VA/NCI/AHRQ Randomized Trial Comparing Radical Prostatectomy With Watchful Waiting In Men with Clinically Localized Prostate Cancer. Main Analyses: 1) Main Outcomes: Primary: Overall Mortality: Time to death from any cause; Secondary: Prostate Cancer Specific Mortality: Time to prostate cancer death Defined as Death Adjudicated by Endpoints Committee as: Definitely or Probably Due to Prostate Cancer or Definitely or Probably Due to Prostate Cancer Treatment a) Intention to treat (RP vs. WW as randomized) analysis a. Time of analysis: i. Time to event ii. Prespecified intervals (30d, mean/median FU [approx 13 years], 5, 10) iii. Time to intervention: 1. RP: time to patients receiving RP (n/n, %, mean time, hazard curves) WW: time to patients receiving RP (n/n, %, mean time, hazard curves) Type of approach Type of procedure Reasons for breach of protocol 2. RP Group: time to patients receiving any definitive therapy (RP, EBRT or Brachytherapy) (n/n, %, mean time) WW Group: pts receiving any definitive therapy (n/n,%, mean time) b. Subgroups: 4 major prespecified: Age, Race, PSA, Tumor characteristic) i. Age: (< vs. >=65) ii. Race: White, Black, Other iii. PSA: < vs >= 10 ng/ml as determined by local laboratory: 1. Central PSA Laboratory data will be utilized to assess disease progression outcomes iv. Gleason Histology: , 7, 8 10 or <7 vs. >=7 1. The Histologic Grade and Clinical Stage used for all analyses will be that ascribed by the local site pathologists and investigators v. Tumor stage: clinical stage as attributed at randomization visit 1. In particular: T1C and Tumors detected by elevated PSA or change in PSA (Q4: Form 2) vi. Tumor risk classification using clinical stage, PSA, Grade: low, medium high vii. Above data as continuous and/or categorical variables in Cox hazards model viii. Tests of interaction and effect modification between variables and outcomes ix. Patient comorbidity scores; Charlson 0 vs. >=1 (Modified 10/10 in Perry Point); Performance Status: Form 02 Q5: (Response of 0 1) Fully active or Symptoms but ambulatory and able to do light work vs. Response of 2 4. Self reported
314 health status of: good, VG or Excellent vs: worse health status. Comorbidity classification revised 10/10 at Perry Point. b) Sensitivity analyses: I ) Treatment received 1) RP Group: patients receiving RP 2) WW group: patients not receiving RP 3) RP Group: patients receiving any definitive therapy (RP, EBRT or Brachytherapy) 4) WW Group: patients not receiving any definitive therapy 5) Excluding randomized subjects without cancer at randomization by local pathology reading 6) Excluding randomized subjects without cancer at randomization as determined by central reading of submitted biopsy specimen 7) Analyses of mortality outcomes by histological grade and tumor risk classification according to central laboratory grading ii) Excluding men where local or central biopsy specimen reading did not confirm cancer 1) Local biopsy specimen negative for cancer (regardless of central reading) 2) Central reading of submitted biopsy specimen was negative for cancer (regardless of local reading) 2) Additional Secondary Outcomes (not QOL related): a. Disease Progression or recurrence: Form 4:Q7 Stable (NEM); Stable (DZ); Disease; asym; DZ symp i. Local ii. Regional iii. Metastatic: Note original protocol: 1. Additionally: + Bone scans coded 4 or 5 for KQ4 on Form 4. (Sensitivity secondary analyses will include adding those with coding of 3) iv. CaP related hospitalizations Q8 b. PSA free survival /progression: (criteria remain to be finalized 11/10) i. PSA free survival: Survival with PSA remaining < 0.04 ii. PSA recurrence following RP: iii. Post RP PSA value of >= 0.2 with a subsequent confirmatory value >= 0.2 from the central laboratory (categorized as Yes/No and then time to recurrence...with the time to recurrence being the 2nd confirmatory report). iv. PSA persistence following RP 1. PSA does not fall to < 0.04 at 6 months after RP v. PSA progression 1. Following RP: a. Definition to be clarified b. Institution of hormonal or other therapy for PSA rise or elevation 2. In WW group: a. PSA > 20 and at least 2x baseline: b. Institution of hormonal or other therapy for PSA rise or elevation c. Bony Metastases: + Bone scans: Baseline, Year 4, 8, 12 [Form 4: Code 4 or 5: Definitely malignant: axial skeleton; definitely malignant > 1 site)). Will also include Cod 3 if other supportive evidence of bony metastases.
315 d. Additional Treatment i. Mechanical ii. Surgical iii. Hormonal therapy (orchiectomy, LHRH, AA) ( n/n, %, time to use) iv. Palliative radiation (n/n, % time to use) v. Laminectomy (n/n, % time to use) e. Reasons for treatment i. Local Disease ii. Regional Disease iii. Metastatic Disease iv. Abnormal Biomarkers f. 30 day surgical complications in RP group by complication g. Surgical Histopathologic Parameters: i. Confined to prostate ii. Capsular invasion iii. Capsular penetration iv. Surgical margins involved v. Seminal vesical invasivion vi. Metastatic Disease vii. Unknown 3) Tables and Figures (main manuscript): a. Figure 1: CONSORT Study Flow Diagram b. Table 1: Base Line Characteristics (see Baseline Paper) c. Table 2: Cause of Death d. Figure 2a: All cause mortality; 2b: <65 vs. >=65 e. Figure 3: Disease specific mortality f. Table 3: Cumulative incidence of Main Endpoints: 5 and 10 years i. Overall mortality ii. Disease Specific Mortality iii. Distant Metastases;: Baseline, Year 1, 5, 10, end of study iv. Local Progression v. Use of Hormonal Therapy vi. Additional palliative treatment: radiation, laminectomy, chemotherapy (individually and cumulatively)
316
317
318
319
320
321
A Competing Risk Analysis of Men Age Years at Diagnosis Managed Conservatively for Clinically Localized Prostate Cancer
A Competing Risk Analysis of Men Age 55-74 Years at Diagnosis Managed Conservatively for Clinically Localized Prostate Cancer Peter C. Albertsen, MD 1 James A. Hanley, PhD 2 Donald F.Gleason, MD, PhD 3
More information2015 myresearch Science Internship Program: Applied Medicine. Civic Education Office of Government and Community Relations
2015 myresearch Science Internship Program: Applied Medicine Civic Education Office of Government and Community Relations Harguneet Singh Science Internship Program: Applied Medicine Comparisons of Outcomes
More informationWhen PSA fails. Urology Grand Rounds Alexandra Perks. Rising PSA after Radical Prostatectomy
When PSA fails Urology Grand Rounds Alexandra Perks Rising PSA after Radical Prostatectomy Issues Natural History Local vs Metastatic Treatment options 1 10 000 men / year in Canada 4000 RRP 15-year PSA
More informationDate Modified: May 29, Clinical Quality Measures for PQRS
Date Modified: May 29, 2014 Clinical Quality s for PQRS # Domain Type Denominator Numerator Denominator Exclusions/Exceptions Rationale QCDR-1 QCDR-2 Patient Safety 102 Efficiency and Cost Reduction QCDR-3
More informationEffective Health Care Program
Comparative Effectiveness Review Number 146 Effective Health Care Program Therapies for Clinically Localized Prostate Cancer: Update of a 2008 Systematic Review Executive Summary Background Prostate cancer
More informationFollow-up of Prostatectomy versus Observation for Early Prostate Cancer
The new england journal of medicine Original Article Follow-up of Prostatectomy versus Observation for Early Prostate Cancer Timothy J. Wilt, M.D., M.P.H., Karen M. Jones, M.S., Michael J. Barry, M.D.,
More informationBIOCHEMICAL RECURRENCE POST RADICAL PROSTATECTOMY
BIOCHEMICAL RECURRENCE POST RADICAL PROSTATECTOMY AZHAN BIN YUSOFF AZHAN BIN YUSOFF 2013 SCENARIO A 66 year old man underwent Robotic Radical Prostatectomy for a T1c Gleason 4+4, PSA 15 ng/ml prostate
More informationGUIDELINEs ON PROSTATE CANCER
GUIDELINEs ON PROSTATE CANCER (Text update March 2005: an update is foreseen for publication in 2010. Readers are kindly advised to consult the 2009 full text print of the PCa guidelines for the most recent
More informationGUIDELINES ON PROSTATE CANCER
10 G. Aus (chairman), C. Abbou, M. Bolla, A. Heidenreich, H-P. Schmid, H. van Poppel, J. Wolff, F. Zattoni Eur Urol 2001;40:97-101 Introduction Cancer of the prostate is now recognized as one of the principal
More informationDate 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 informationUnderstanding the risk of recurrence after primary treatment for prostate cancer. Aditya Bagrodia, MD
Understanding the risk of recurrence after primary treatment for prostate cancer Aditya Bagrodia, MD Aditya.bagrodia@utsouthwestern.edu 423-967-5848 Outline and objectives Prostate cancer demographics
More informationProstate Overview Quiz
Prostate Overview Quiz 1. The path report reads: Gleason 3 + 4 = 7. The Gleason s score is a. 3 b. 4 c. 7 d. None of the above 2. The path report reads: Moderately differentiated adenocarcinoma of the
More informationOverview of Radiotherapy for Clinically Localized Prostate Cancer
Session 16A Invited lectures: Prostate - H&N. Overview of Radiotherapy for Clinically Localized Prostate Cancer Mack Roach III, MD Department of Radiation Oncology UCSF Helen Diller Family Comprehensive
More informationMETASTATIC PROSTATE CANCER MANAGEMENT K I R U B E L T E F E R A M. D. T R I H E A LT H C A N C E R I N S T I T U T E 0 1 / 3 1 /
METASTATIC PROSTATE CANCER MANAGEMENT K I R U B E L T E F E R A M. D. T R I H E A LT H C A N C E R I N S T I T U T E 0 1 / 3 1 / 2 0 1 8 Prostate Cancer- Statistics Most common cancer in men after a skin
More informationACTIVE SURVEILLANCE OR WATCHFUL WAITING
Prostate Cancer ACTIVE SURVEILLANCE OR WATCHFUL WAITING María Teresa Bourlon, MD MS Head, Urologic Oncology Clinic Hemato-Oncology Department Instituto Nacional de Ciencias Médicas y Nutrición Salvador
More informationRadical prostate surgery?
Decipher enables personalized and actionable treatment after surgery Radical prostate surgery? The Decipher Prostate Cancer Classifier can help you and your doctor decide on important next steps in your
More informationLocalized Prostate Cancer Have we finally got it right? Shingai Mutambirwa Professor & Chair-Division Urology DGMAH & SMU Pretoria SOUTH AFRICA
Localized Prostate Cancer Have we finally got it right? Shingai Mutambirwa Professor & Chair-Division Urology DGMAH & SMU Pretoria SOUTH AFRICA ESMO Cape Town 14 Feb 2018 Disclosures Advisory boards/lecturer/consultant-
More informationProstate Cancer Incidence
Prostate Cancer: Prevention, Screening and Treatment Philip Kantoff MD Dana-Farber Cancer Institute Professor of fmedicine i Harvard Medical School Prostate Cancer Incidence # of patients 350,000 New Cases
More informationjournal of medicine The new england Preoperative PSA Velocity and the Risk of Death from Prostate Cancer after Radical Prostatectomy abstract
The new england journal of medicine established in 1812 july 8, 4 vol. 31 no. 2 Preoperative PSA Velocity and the Risk of Death from Prostate Cancer after Radical Prostatectomy Anthony V. D Amico, M.D.,
More informationAccepted for publication 3 January 2005
Original Article RACIAL DIFFERENCES IN PSA DOUBLING TIME AND RECURRENCE TEWARI et al. In a multi-institutional study authors from the USA and Austria attempt to determine if there are differences in several
More informationBest Papers. F. Fusco
Best Papers UROLOGY F. Fusco Best papers - 2015 RP/RT Oncological outcomes RP/RT IN ct3 Utilization trends RP/RT Complications Evolving role of elnd /Salvage LND This cohort reflects the current clinical
More informationSalvage prostatectomy for post-radiation adenocarcinoma with treatment effect: Pathological and oncological outcomes
ORIGINAL RESEARCH Salvage prostatectomy for post-radiation adenocarcinoma with treatment effect: Pathological and oncological outcomes Michael J. Metcalfe, MD ; Patricia Troncoso, MD 2 ; Charles C. Guo,
More informationVALUE AND ROLE OF PSA AS A TUMOUR MARKER OF RESPONSE/RELAPSE
Session 3 Advanced prostate cancer VALUE AND ROLE OF PSA AS A TUMOUR MARKER OF RESPONSE/RELAPSE 1 PSA is a serine protease and the physiological role is believed to be liquefying the seminal fluid PSA
More informationPROSTATE CANCER SURVEILLANCE
PROSTATE CANCER SURVEILLANCE ESMO Preceptorship on Prostate Cancer Singapore, 15-16 November 2017 Rosa Nadal National Cancer Institute, NIH Bethesda, USA DISCLOSURE No conflicts of interest to declare
More informationRadical Prostatectomy:
Overtreatment and undertreatment Radical Prostatectomy: An Emerging Standard of Care for High Risk Prostate Cancer Matthew R. Cooperberg, MD,MPH UCSF Radiation Oncology Update San Francisco, CA April 2,
More informationFactors Associated with Initial Treatment for Clinically Localized Prostate Cancer
Factors Associated with Initial Treatment for Clinically Localized Prostate Cancer Preliminary Results from the National Program of Cancer Registries Patterns of Care Study (PoC1) NAACCR Annual Meeting
More informationPaul F. Schellhammer, M.D. Eastern Virginia Medical School Urology of Virginia Norfolk, Virginia
Paul F. Schellhammer, M.D. Eastern Virginia Medical School Urology of Virginia Norfolk, Virginia Virginia - Chesapeake Bay Landfall: Virginia Beach, April 29 th, 1607 PSA Failure after Radical Prostatectomy
More informationOutcomes Following Negative Prostate Biopsy for Patients with Persistent Disease after Radiotherapy for Prostate Cancer
Clinical Urology Post-radiotherapy Prostate Biopsy for Recurrent Disease International Braz J Urol Vol. 36 (1): 44-48, January - February, 2010 doi: 10.1590/S1677-55382010000100007 Outcomes Following Negative
More informationWhat Is Prostate Cancer? Prostate cancer is the development of cancer cells in the prostate gland (a gland that produces fluid for semen).
What Is Prostate Cancer? Prostate cancer is the development of cancer cells in the prostate gland (a gland that produces fluid for semen). It is a very common cancer in men; some cancers grow very slowly,
More informationNavigating the Stream: Prostate Cancer and Early Detection. Ifeanyi Ani, M.D. TPMG Urology Newport News
Navigating the Stream: Prostate Cancer and Early Detection Ifeanyi Ani, M.D. TPMG Urology Newport News Understand epidemiology of prostate cancer Discuss PSA screening and PSA controversy Review tools
More information2018 OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY. MEASURE TYPE: Process
Quality ID #102 (NQF 0389): Prostate Cancer: Avoidance of Overuse of Bone Scan for Staging Low Risk Prostate Cancer Patients National Quality Strategy Domain: Efficiency and Cost Reduction 2018 OPTIONS
More informationDefinition Prostate cancer
Prostate cancer 61 Definition Prostate cancer is a malignant neoplasm that arises from the prostate gland and the most common form of cancer in men. localized prostate cancer is curable by surgery or radiation
More informationA schematic of the rectal probe in contact with the prostate is show in this diagram.
Hello. My name is William Osai. I am a nurse practitioner in the GU Medical Oncology Department at The University of Texas MD Anderson Cancer Center in Houston. Today s presentation is Part 2 of the Overview
More informationQUALIFIED CLINICAL DATA REGISTRY (QCDR) 2017 MEASURE SPECIFICATIONS
QOPI5 Chemotherapy administered to patients with metastatic solid tumor with performance status of 3, 4, or undocumented (Lower Score - Better) Percentage of adult patients with metastatic solid tumors
More informationPROVIDING TREATMENT INFORMATION FOR PROSTATE CANCER PATIENTS
PROVIDING TREATMENT INFORMATION FOR PROSTATE CANCER PATIENTS For patients with localized disease on biopsy* For patients with adverse pathology after prostatectomy Contact the GenomeDx Customer Support
More informationProstate Cancer Local or distant recurrence?
Prostate Cancer Local or distant recurrence? Diagnostic flowchart Vanessa Vilas Boas Urologist VFX Hospital FEBU PSA - only recurrence PSA recurrence: 27-53% of all patients undergoing treatment with curative
More informationPSA nadir post LDR Brachytherapy and early Salvage Therapy. Dr Duncan McLaren UK & Ireland Users Group Meeting 2016
PSA nadir post LDR Brachytherapy and early Salvage Therapy Dr Duncan McLaren UK & Ireland Users Group Meeting 2016 Differences in PSA relapse rates based on definition used PSA ng/ml Recurrence ASTRO Recurrence
More informationRadical Prostatectomy or Watchful Waiting in Early Prostate Cancer
The new england journal of medicine original article Radical Prostatectomy or Watchful Waiting in Early Prostate Cancer Anna Bill-Axelson, M.D., Ph.D., Lars Holmberg, M.D., Ph.D., Hans Garmo, Ph.D., Jennifer
More informationAdvances and Challenges in Radiation Protection of Patients Modern Radiotherapy. Risk Acceptability
Advances and Challenges in Radiation Protection of Patients Modern Radiotherapy Risk Acceptability Versailles, France December 2-4, 2009 Fred A. Mettler Jr. M.,D., M.P.H. New Mexico Federal Regional Medical
More informationObjectives. Prostate Cancer Screening and Surgical Management
Prostate Cancer Screening and Surgical Management Dr. Ken Jacobsohn Director, Minimally Invasive Urologic Surgery Assistant Professor, Department of Urology Medical College of Wisconsin Objectives Update
More informationProstatectomy as salvage therapy. Cases. Paul Cathcart - Guy s & St Thomas NHS Trust, London
Prostatectomy as salvage therapy Cases Paul Cathcart - Guy s & St Thomas NHS Trust, London Attributes of brachytherapy appeal to young men who place high utility on genitourinary function At risk of
More informationGenomics and Genetic Testing. Copyright 2017 Myriad Genetics, Inc., all rights reserved.
Genomics and Genetic Testing Copyright 2017 Myriad Genetics, Inc., all rights reserved. www.myriad.com Why is genetic testing important to you? Impact on immediate treatment decisions Identify risks for
More informationRadical Prostatectomy: Management of the Primary From Localized to Oligometasta:c Disease
Radical Prostatectomy: Management of the Primary From Localized to Oligometasta:c Disease Disclosures I do not have anything to disclose Sexual function causes moderate to severe distress 2 years after
More informationOutcomes With "Watchful Waiting" in Prostate Cancer in US Now So Good, Active Treatment May Not Be Better
1 sur 5 19/09/2009 07:02 www.medscape.com From Medscape Medical News Outcomes With "Watchful Waiting" in Prostate Cancer in US Now So Good, Active Treatment May Not Be Better Zosia Chustecka September
More informationProstate Cancer: Screening, Treatment, and Survivorship
Prostate Cancer: Screening, Treatment, and Survivorship Timothy C. Brand, MD, FACS LTC(P), MC, USA Urology Residency Director Associate Professor of Surgery, USUHS Madigan Army Medical Center No Disclosures
More informationIn autopsy, 70% of men >80yr have occult prostate ca
Prostate Cancer UpToDate: Introduction: Risk Factors: Biology: Symptoms: Diagnosis: Two randomized trials showed survival benefit of adding docetaxol to ADT in fit man with very high localized disease
More informationRadical prostatectomy as radical cure of prostate cancer in a high risk group: A single-institution experience
MOLECULAR AND CLINICAL ONCOLOGY 1: 337-342, 2013 Radical prostatectomy as radical cure of prostate cancer in a high risk group: A single-institution experience NOBUKI FURUBAYASHI 1, MOTONOBU NAKAMURA 1,
More informationWhen to worry, when to test?
Focus on CME at the University of Calgary Prostate Cancer: When to worry, when to test? Bryan J. Donnelly, MSc, MCh, FRCSI, FRCSC Presented at a Canadian College of Family Practitioner s conference (October
More information2016 PQRS OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY
Measure #104 (NQF 0390): Prostate Cancer: Adjuvant Hormonal Therapy for High Risk or Very High Risk Prostate Cancer National Quality Strategy Domain: Effective Clinical Care 2016 PQRS OPTIONS FOR INDIVIDUAL
More informationCase Discussions: Prostate Cancer
Case Discussions: Prostate Cancer Andrew J. Stephenson, MD FRCSC FACS Chief, Urologic Oncology Glickman Urological and Kidney Institute Cleveland Clinic Elevated PSA 1 54 yo, healthy male, family Hx of
More informationNIH Public Access Author Manuscript World J Urol. Author manuscript; available in PMC 2012 February 1.
NIH Public Access Author Manuscript Published in final edited form as: World J Urol. 2011 February ; 29(1): 11 14. doi:10.1007/s00345-010-0625-4. Significance of preoperative PSA velocity in men with low
More informationQuality ID #250 (NQF 1853): Radical Prostatectomy Pathology Reporting National Quality Strategy Domain: Effective Clinical Care
Quality ID #250 (NQF 1853): Radical Prostatectomy Pathology Reporting National Quality Strategy Domain: Effective Clinical Care 2018 OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY MEASURE TYPE: Process
More informationUse of the cell cycle progression (CCP) score for predicting systemic disease and response to radiation of biochemical recurrence
Cancer Biomarkers 17 (2016) 83 88 83 DOI 10.3233/CBM-160620 IOS Press Use of the cell cycle progression (CCP) score for predicting systemic disease and response to radiation of biochemical recurrence Michael
More informationProstate Biopsy. Prostate Biopsy. We canʼt go backwards: Screening has helped!
We canʼt go backwards: Screening has helped! Robert E. Donohue M.D. Denver V.A. Medical Center University of Colorado Prostate Biopsy Is cure necessary; when it is possible? Is cure possible; when it is
More informationProstate MRI: Who needs it?
Prostate MRI: Who needs it? Fergus Coakley MD, Professor of Radiology and Urology, Vice Chair for Clinical Services, Chief of Abdominal Imaging, UCSF Abdominal Imaging Magnetic Resonance Science Center
More informationPROSTATE CANCER CLINICAL PRACTICE GUIDELINES: CLINICAL AND ECONOMIC OUTCOMES
PROSTATE CANCER CLINICAL PRACTICE GUIDELINES: CLINICAL AND ECONOMIC OUTCOMES By MICHAEL DENNIS TAYLOR A DISSERTATION PRESENTED TO THE GRADUATE SCHOOL OF THE UNIVERSITY OF FLORIDA IN PARTIAL FULFILLMENT
More informationPlease consider the following information on ZYTIGA (abiraterone acetate). ZYTIGA - Compendia Communication - NCCN LATITUDE and STAMPEDE June 2017
Page 1 of 2 Janssen Scientific Affairs, LLC 1125 Trenton-Harbourton Road PO Box 200 Titusville, NJ 08560 800.526.7736 tel 609.730.3138 fax June 08, 2017 Joan McClure 275 Commerce Drive #300 Fort Washington,
More informationMEDICAL 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 informationThe Selenium and Vitamin E Prevention Trial
The largest-ever-prostate cancer prevention trial is now underway. The study will include a total of 32,400 men and is sponsored by the National Cancer Institute and a network of researchers known as the
More informationPost Radical Prostatectomy Radiation in Intermediate and High Risk Group Prostate Cancer Patients - A Historical Series
Post Radical Prostatectomy Radiation in Intermediate and High Risk Group Prostate Cancer Patients - A Historical Series E. Z. Neulander 1, Z. Wajsman 2 1 Department of Urology, Soroka UMC, Ben Gurion University,
More informationPersonalized Therapy for Prostate Cancer due to Genetic Testings
Personalized Therapy for Prostate Cancer due to Genetic Testings Stephen J. Freedland, MD Professor of Urology Director, Center for Integrated Research on Cancer and Lifestyle Cedars-Sinai Medical Center
More informationNCDB Special Study: Post-Active Treatment Surveillance in Prostate Cancer Webinar #4: NCRA /2/17 Eileen Tonner, MS
NCDB Special Study: Post-Active Treatment Surveillance in Prostate Cancer Webinar #4: NCRA 2017-040 5/2/17 Eileen Tonner, MS Purpose of the Study For patients who have received curative-intent prostate
More informationHormone therapy works best when combined with radiation for locally advanced prostate cancer
Hormone therapy works best when combined with radiation for locally advanced prostate cancer Phichai Chansriwong, MD Ramathibodi Hospital, Mahidol University Introduction Introduction 1/3 of patients
More informationScreening and Diagnosis Prostate Cancer
Screening and Diagnosis Prostate Cancer Daniel Heng MD MPH FRCPC Chair, Genitourinary Tumor Group Tom Baker Cancer Center University of Calgary, Canada @DrDanielHeng Outline Screening Evidence Recommendations
More informationNCDB Special Study: Post-Active Treatment Surveillance in Prostate Cancer Webinar #10: NCRA /13/17 Eileen Tonner, MS
NCDB Special Study: Post-Active Treatment Surveillance in Prostate Cancer Webinar #10: NCRA 2017-063 6/13/17 Eileen Tonner, MS Study Progress as of 6/13 Number of patients submitted as eligible: 2449 Number
More informationS1.04 PRINCIPAL CLINICIAN G1.01 COMMENTS S2.01 SPECIMEN LABELLED AS G2.01 *SPECIMEN DIMENSIONS (PROSTATE) S2.03 *SEMINAL VESICLES
Prostate Cancer Histopathology Reporting Proforma (Radical Prostatectomy) Includes the International Collaboration on Cancer reporting dataset denoted by * Family name Given name(s) Date of birth Indigenous
More informationNATIONAL QUALITY FORUM
Cancer Endorsement Maintenance Table of Submitted Measures Phase I 0210 1 Proportion receiving chemotherapy in the last 14 days of life Percentage of patients who died from cancer receiving chemotherapy
More information2018 OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY. MEASURE TYPE: Process
Quality ID #104 (NQF 0390): Prostate Cancer: Combination Androgen Deprivation Therapy for High Risk or Very High Risk Prostate Cancer National Quality Strategy Domain: Effective Clinical Care 2018 OPTIONS
More informationPSA. HMCK, p63, Racemase. HMCK, p63, Racemase
Case 1 67 year old male presented with gross hematuria H/o acute prostatitis & BPH Urethroscopy: small, polypoid growth with a broad base emanating from the left side of the verumontanum Serum PSA :7 ng/ml
More informationPET imaging of cancer metabolism is commonly performed with F18
PCRI Insights, August 2012, Vol. 15: No. 3 Carbon-11-Acetate PET/CT Imaging in Prostate Cancer Fabio Almeida, M.D. Medical Director, Arizona Molecular Imaging Center - Phoenix PET imaging of cancer metabolism
More informationMeasure #250 (NQF 1853): Radical Prostatectomy Pathology Reporting National Quality Strategy Domain: Effective Clincial Care
Measure #250 (NQF 1853): Radical Prostatectomy Pathology Reporting National Quality Strategy Domain: Effective Clincial Care 2016 PQRS OPTIONS FOR INDIVIDUAL MEASURES: CLAIMS, REGISTRY DESCRIPTION: Percentage
More informationElevated PSA. Dr.Nesaretnam Barr Kumarakulasinghe Associate Consultant Medical Oncology National University Cancer Institute, Singapore 9 th July 2017
Elevated PSA Dr.Nesaretnam Barr Kumarakulasinghe Associate Consultant Medical Oncology National University Cancer Institute, Singapore 9 th July 2017 Issues we will cover today.. The measurement of PSA,
More informationProstate cancer: intervention comparisons
National Institute for Health and Care Excellence Guideline version (Draft) Prostate cancer: intervention comparisons [G] Evidence reviews for active surveillance, radical prostatectomy or radical radiotherapy
More informationClinical Case Conference
Clinical Case Conference Intermediate-risk prostate cancer 08/06/2014 Long Pham Clinical Case 64 yo man was found to have elevated PSA of 8.65. TRUS-biopies were negative. Surveillance PSA was 7.2 in 3
More informationNCDB Special Study: Post-Active Treatment Surveillance in Prostate Cancer. Project Overview Ronald C. Chen, MD MPH
NCDB Special Study: Post-Active Treatment Surveillance in Prostate Cancer Project Overview Ronald C. Chen, MD MPH Introductions Principal Investigator: Ronald C. Chen, MD MPH ACS Staff: Eileen Tonner,
More informationPROSTATE CANCER Amit Gupta MD MPH
PROSTATE CANCER Amit Gupta MD MPH Depts. of Urology and Epidemiology Amit-Gupta-1@uiowa.edu dramitgupta@gmail.com Tel: 319-384-5251 OUTLINE PSA screening controversy How to use PSA more effectively Treatment
More informationState-of-the-art: vision on the future. Urology
State-of-the-art: vision on the future Urology Francesco Montorsi MD FRCS Professor and Chairman Department of Urology San Raffaele Hospital Vita-Salute San Raffaele University Milan, Italy Disclosures
More informationProstate Cancer: 2010 Guidelines Update
Prostate Cancer: 2010 Guidelines Update James L. Mohler, MD Chair, NCCN Prostate Cancer Panel Associate Director for Translational Research, Professor and Chair, Department of Urology, Roswell Park Cancer
More informationPROSTATE CANCER STRATIFIED FOLLOW UP. Hilary Baker Lead CNS for Uro-oncology MSc, BSc, RGN.
PROSTATE CANCER STRATIFIED FOLLOW UP Hilary Baker Lead CNS for Uro-oncology MSc, BSc, RGN. LEARNING OBJECTIVES To refresh your knowledge about prostate cancer. To discuss the purpose and patient benefits
More informationProstate Case Scenario 1
Prostate Case Scenario 1 H&P 5/12/16: A 57-year-old Hispanic male presents with frequency of micturition, urinary urgency, and hesitancy associated with a weak stream. Over the past several weeks, he has
More informationMultidisciplinary Quality of Life Intervention for Men with Biochemical Recurrence of Prostate Cancer
Multidisciplinary Quality of Life Intervention for Men with Biochemical Recurrence of Prostate Cancer Steven C. Ames, PhD, ABPP Division of Hematology & Oncology Investigative Team Winston W. Tan, MD Mayo
More informationreviews LHRH Agonists in the Treatment of Advanced Carcinoma of the Prostate therapy
reviews therapy LHRH Agonists in the Treatment of Advanced Carcinoma of the Prostate Martin I. Resnick, MD, Lester Persky Professor and Chief, Department of Urology, Case Western Reserve University School
More informationX, Y and Z of Prostate Cancer
X, Y and Z of Prostate Cancer Dr Tony Michele Medical Oncologist Prostate cancer Epidemiology Current EUA (et al) guidelines on Advanced Prostate Cancer Current clinical management in specific scenarios
More information10/2/2018 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 information2/14/09. Why Discuss this topic? Managing Local Recurrences after Radiation Failure. PROSTATE CANCER Second Treatment
Why Discuss this topic? Mack Roach III, MD Professor and Chair Radiation Oncology UCSF Managing Local Recurrences after Radiation Failure 1. ~15 to 75% of CaP pts recur after definitive RT. 2. Heterogeneous
More informationProviding Treatment Information for Prostate Cancer Patients
Providing Treatment Information for Prostate Cancer Patients For all patients with localized disease on biopsy For all patients with adverse pathology after prostatectomy See what better looks like Contact
More informationCommunity care of Prostate Cancer. Shaun Costello Southern Cancer Network
Community care of Prostate Cancer Shaun Costello Southern Cancer Network Introduction Why is GP follow up of prostate cancer important 4Years In Waikato Faster Cancer Treatment Reporting against the 3
More informationRadiation Therapy After Radical Prostatectomy
Articles ISSN 1537-744X; DOI 10.1100/tsw.2004.93 Radiation Therapy After Radical Ali M. Ziada, M.D. and E. David Crawford, M.D. Division of Urology, University of Colorado, Denver, Colorado E-mails: aziada@mednet3.camed.eun.eg
More informationPROSTATE CANCER: A Primer of Diagnosis and Treatment. Jay C. Lee, MD, FRCSC Clinical Associate Professor University of Calgary
PROSTATE CANCER: A Primer of Diagnosis and Treatment Jay C. Lee, MD, FRCSC Clinical Associate Professor University of Calgary Copyright 2017 by Sea Courses Inc. All rights reserved. No part of this document
More informationAccuracy of post-radiotherapy biopsy before salvage radical prostatectomy
Accuracy of post-radiotherapy biopsy before salvage radical prostatectomy Joshua J. Meeks, Marc Walker*, Melanie Bernstein, Matthew Kent and James A. Eastham Urology Service, Department of Surgery and
More informationProstate Cancer Screening. Eric Shreve, MD Bend Urology Associates
Prostate Cancer Screening Eric Shreve, MD Bend Urology Associates University of Cincinnati Medical Center University of Iowa Hospitals and Clinics PSA Human kallikrein 3 Semenogelin is substrate Concentration
More information3/22/2014. Goals of this Presentation: in 15 min & 5 min Q & A. Radiotherapy for. Localized Prostate Cancer: What is New in 2014?
3/22/ Goals of this Presentation: in 15 min & 5 min Q & A 1. Potency Preservation. a. Dosimetric considerations Radiotherapy for b. Drugs 2. Update on duration of short term ADT Mack III, MD Professor
More informationWhen radical prostatectomy is not enough: The evolving role of postoperative
When radical prostatectomy is not enough: The evolving role of postoperative radiation therapy Dr Tom Pickles Clinical Associate Professor, UBC. Chair, Provincial Genito-Urinary Tumour Group BC Cancer
More informationPLACE LABEL HERE. ACRIN 6659 Registration/Eligibility Institution
A0 ACRIN 6659 Registration/Eligibility No Case No Instructions: For potential study participants, Part 2 must be completed before Part 1 If any of the answers, for Part 2, vary from the prompts provided
More informationin 32%, T2c in 16% and T3 in 2% of patients.
BJUI Gleason 7 prostate cancer treated with lowdose-rate brachytherapy: lack of impact of primary Gleason pattern on biochemical failure Richard G. Stock, Joshua Berkowitz, Seth R. Blacksburg and Nelson
More informationTiming of Androgen Deprivation: The Modern Debate Must be conducted in the following Contexts: 1. Clinical States Model
Timing and Type of Androgen Deprivation Charles J. Ryan MD Associate Professor of Clinical Medicine UCSF Comprehensive Cancer Center Timing of Androgen Deprivation: The Modern Debate Must be conducted
More information17/07/2014. Prostate Cancer Watchful Waiting New Treatments Andrew Williams Urologist and Urological Oncologist ADHB, CMDHB and 161 Gillies Ave, Epsom
My Biases Prostate Cancer Watchful Waiting New Treatments Andrew Williams Urologist and Urological Oncologist ADHB, CMDHB and 161 Gillies Ave, Epsom I am a member of the specialist group of the Prostate
More informationCancer Endorsement Maintenance 2011-Maintenance Measures
Measure Number Title Description Measure Steward 0210 Proportion receiving chemotherapy in the last 14 days of life 0211 Proportion with more than one emergency room visit in the last days of life 0212
More informationIntroduction. Original Article
bs_bs_banner International Journal of Urology (2015) 22, 363 367 doi: 10.1111/iju.12704 Original Article Prostate-specific antigen level, stage or Gleason score: Which is best for predicting outcomes after
More informationQ&A. Overview. Collecting Cancer Data: Prostate. Collecting Cancer Data: Prostate 5/5/2011. NAACCR Webinar Series 1
Collecting Cancer Data: Prostate NAACCR 2010-2011 Webinar Series May 5, 2011 Q&A Please submit all questions concerning webinar content through the Q&A panel Overview NAACCR 2010-2011 Webinar Series 1
More information