PACE Study. Hypofractionation 17/12/2014. Traditional Model of Fractionation 200 Response. What s the fraction sensitivity of prostate cancer?

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1 0 0 17/12/ Outline of today s talk PACE Study Background rationale for PACE? Dr Nicholas van As A bit about technology. What is PACE? How can I get involved? London: 1 December Hypofractionation Traditional Model of Fractionation 200 Response 150 Late adverse effects α/β<10gy 100 Tumour control α/β 10Gy Fraction size (Gy) Courtesy of Prof.John Yarnold New Model of Tumour Fractionation 200 Response 150 Breast and prostate cancer α/β<10gy What s the fraction sensitivity of prostate cancer? Other tumours α/β 10Gy Fraction size (Gy) Courtesy of Prof.John Yarnold 1

2 Gy in 39 fractions Gy in 5 fractions BED if α/β ratio = 5 BED if α/β ratio = 4 BED if α/β ratio = 3 BED if α/β ratio = 2.7 BED if α/β ratio = Gy 117 Gy 130 Gy 135 Gy 182 Gy 88 Gy 101 Gy 123Gy 134 Gy 211 Gy Is using hypofrctionation, dose escalation by stealth? Radiation dose response trials radiotherapy Dose 1 prostate cancer (usuallyt1b T4N0M0) randomize no. patients radiotherapy Dose 2 Prostate cancer dose escalation trials Prostate cancer dose escalation trials Institute no pts dose comparisonlhrha MD Anderson US vs 78Gy ICR/RMH UK vs 74 Gy ± MRC RT01 UK vs 74 Gy ± Netherlands NL vs 78Gy ± FNC LCC F vs 78Gy Mass/Loma Linda US vs 78Gy RTOG US vs 78Gy Netherlands - Photons Netherlands - Photons Peeters et al 2006 Prostate cancer dose escalation trials 2

3 St. Thomas Hospital; 1991 (UK)( ) Radical external beam radiotherapy for localised carcinoma of the prostate using a hypofractionation technique Retrospective 232 patients, clinically localized PCA. RT 36/6 Conclusion: Comparable results to other series, early and late morbidity acceptable Collins CD, Clin Oncol (R Coll Radiol) May;3(3): Christie Hospital, UK; 2009 ( ) Hypofractionated conformal radiotherapy in carcinoma of the prostate: five-year outcome analysis Retrospective. 705 men with T1-T4N0 PCA, 4F conformal RT dose 3.13 Gy/fx. Conclusion: Similar tumor control and toxicity to standard Gy Livsey JE, Int J Radiat Oncol Biol Phys Dec 1;57(5): Randomised evidence A Prospective Phase III Randomized Trial of Hypofractionation Versus Conventional Fractionation in Patients with High-Risk Prostate Cancer 80/40 (2 Gy/fx) vs 62/20 (3.1 Gy/fx) 3-year bpfs conventional 79% vs hypofx 87% Conclusion: Hypofractionated schedule superior for biochemical control, comparable for late toxicity CHHiP : Phase III Trial of Conventional or Hypofractionated High Dose intensity Modulated Radiotherapy in Prostate Cancer Conventional 74Gy 37F 7.4w Hypofractionated 60Gy 20F 4w Hypofractionated 57Gy 19F 3.8w Part 1 Pilot randomised phase I : 2 centres (n=150) Part 2 Preliminary phase III study : 6 centres (n=450) Part 3 Full Phase III trial : 20 centres (n=3000) Arcangeli G, Int J Radiat Oncol Biol Phys Jan 2. [Epub ahead of print] Evidence for profound hypofractionation Randomised trials 3

4 19 20 Phase III study of HYPOfractionated RadioTherapy of intermediate risk localised Prostate Cancer Fractionation schedule and treatment durations: Conventional arm: 39 fractions of 2.0 Gy, = 78.0 Gy. Non randomised data Hypofractionated arm: radiotherapy is given working-days with 7 fractions of 6.1 Gy, = 42.7 Gy. Prof Anders Widmark Stereotactic Body Radiotherapy for Intermediate-risk Organ-confined Prostate Cancer: Interim Toxicity and Quality of Life Outcomes from a Multi-Institutional Study Robert Meier, MD Swedish Cancer Institute, Seattle WA I. Kaplan 2, A. Beckman 3, G. Henning 4, S. Woodhouse 5, S. Williamson 6, N. Mohideen 7, D. Herold 8, C. Cotrutz 1, M. Sanda 2 2 Beth Israel Deaconess Medical Center, Boston, MA 3 Central Baptist Hospital, Lexington, KY 4 St. Joseph Mercy Hospital System, Ypsilanti, MI 5 Community Cancer Center, Normal, IL 6 Capital Health System, Trenton, NJ 7 Northwest Community Hospital, Arlington Heights, IL 8 Jupiter Medical Center, Jupiter, FL 129 patients enrolled December 2007 through April centers Follow up 2 4½ yrs Median 36 months Central pathology review Data courtesy of Bob Meier Age (yrs) Clinical Stage Initial PSA (ng/ml) Gleason Score Prostate Vol (cc) Patient Characteristics Mean 69 Range T1a 0 T1b 2 (2%) T1c 100 (76%) T2a 19 (15%) T2b 8 (6%) Mean 6.49 Range (26%) (54%) (20%) Mean 42 Range Data courtesy of Bob Meier Data courtesy of Bob Meier 4

5 Median PSA (ng/ml) 17/12/2014 PSA Response # Pts (129) (122) (114) (72) (17) Months after Treatment (# pts) SBRT for Localized Prostate Cancer: 5 year outcomes Debra Freeman and Christopher King Data courtesy of Bob Meier Results 43 pts.with minimum 5 yr. follow up 5 yr. biochemical progression-free survival of 92.7% Mean post-treatment PSA = biochemical failures (33 mos, 37 mos, 42 mos); all biopsy-confirmed Toxicity 30 Results No grade 3 rectal toxicity One grade 3 urinary toxicity (dysuria), following repeated instrumentation No incontinence reported ED rate 18-48% King, et al, have reported pooled data from a consortium of institutions treating with the Cyberknife system 1100 patients with a median follow up of 36 months Biochemical relapse free survival (brfs) at 5 years was 95%, 84%, and 81% for low, intermediate, and high risk disease, respectively 5

6 Prostate SBRT 32 Good outcomes PSA and toxicity Technology But without randomisation, where is the evidence that this is equivalent to conventionally fractionated IMRT? 34 Arc therapy RapidArc VMAT 35 6

7 38 CyberKnife Question 1: PACE Is SBRT equivalent to surgery for men with localised prostate cancer? 7

8 Question 2 44 PACE Study Overview Study Scheme Is SBRT as good, or better, than current standard radiotherapy regimens? Early Stage Prostate Cancer Surgical Consideration Yes No Randomize n=858 Randomize n=858 Laparoscopic prostatectomy SBRT 36.25Gy/5# SBRT 36.25Gy/5# Conventional IGRT (78Gy/39#) Study treatments Pace Study Objectives Prostatectomy: Laparoscopic or robot-assisted laparoscopic Conventional radiotherapy: Image-guided (fiducials) IMRT 78Gy/39# daily No androgen deprivation therapy SBRT: Robotic or gantry-based 36.25Gy/5# daily or alternate daily No androgen deprivation therapy Primary objectives: To determine whether prostate SBRT is noninferior to laparoscopic prostatectomy. To determine whether prostate SBRT is noninferior to conventional radiotherapy (imageguided IMRT). Primary end-point: biochemical progression-free survival at 5 years. 47 Pace Study Objectives Pace Study Inclusion Criteria Secondary objective: To determine the relative benefits of prostatectomy, conventional radiotherapy and SBRT, with respect to: local failure distant failure disease-free survival disease-specific survival overall survival toxicity quality of life (generic and organ specific domains) Low and intermediate risk organ confined prostate cancer Clinical and MRI stage T1c T2c, N0-X, M0-X Gleason score 3+4 PSA 20 ng/ml (completed within 60 days of registration) Histological confirmation of prostate adenocarcinoma, min 10 biopsy core WHO performance status 0 2 Prostate volume 90 cc Ability of the research subject to understand and the willingness to sign a written informed consent document 8

9 Pace Study Exclusion Criteria Recruitment Clinical stage T3 or greater Gleason score 4+3 Prior pelvic radiotherapy Prior androgen deprivation therapy Prior treatment for prostate cancer (active surveillance ok) Life expectancy < 5 years Previous malignancy in last five years except BCC or SCC skin Currently 160 patients have been recruited by two UK centres. Experience has been that patients are keen to participate in this study and accept randomisation. Recruitment is lower than anticipated at this point due to delays in sponsorship transfer from Accuray inc. to Royal Marsden. Sponsorship is now resolved, and recuitment is expected to complete in early 2017; at least 20 centres in the UK and internationally are keen to participate. Adverse Events and Quality of Life Assessment Pace Study Quality Assurance Adverse Events Grading CTCAEv4 and RTOG scales International Prostate Symptom Score (IPSS) International Index of Erectile Function (IIEF) Vaizey patient questionnaire to assess bowel function EPIC patient questionnaire to assess urinary, bowel, sexual function Surgery QA minimum number of procedures per year >20 data on surgical margin positivity and postoperative complications SBRT and RT Calibration, daily and intermittent QA performed as per local guidelines Approved by the Physics Chair Planning QA Benchmark Study first patient for each treatment allocation pre-treatment one patient per year post-treatment Data management and results 54 Data management and results Trial now sponsored by Hospital NHS Foundation Trust Unrestricted grant provided by Accuray inc. All the data will be analysed by the Clinical Trials Unit of the Institute for Cancer Research, UK IDMC (independent data monitoring committee) Prof Søren Bentzen Prof Joe O Sulivan Dr TSC Raj (Trial Persad steering committee) Prof Anthony Zietman Prof Mark Emberton Dr Ann Henry Prof Gert De Meerler Dr John Norrie 9

10 55 56 Contacts Chief Investigator: Dr Nicholas van As Research fellow: Dr Daniel Henderson Thank you 10

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