Final analysis of intergroup randomized phase III study of androgen deprivation therapy (ADT) plus radiation therapy (RT) in locally advanced prostate cancer (CaP) (NCIC-CTG, SWOG, MRC-UK, INT: T94-0110).

Genitourinary Cancer
Session Type and Session Title: 
Oral Abstract Session, Genitourinary Cancer (Prostate)
Abstract Number: 


J Clin Oncol 30, 2012 (suppl; abstr 4509)
Malcolm David Mason, Wendy Parulekar, Matthew Robert Sydes, Mahesh Parmar, John Anderson, Jim Barber, Michael Donald Brundage, Richard Cowan, Mary K. Gospodarowicz, Charles Hayter, John Hetherington, Andrea Clare Hiltz, Peter Kirkbride, Edward Kostashuk, Karen Sanders, Jinka Sathya, Gregory P. Swanson, Bingshu E Chen, Padraig Richard Warde, NCIC-CTG PR3/MRC UK PR07 Investigators; Cardiff University, Cardiff, United Kingdom; NCIC Clinical Trials Group, Queen's University, Kingston, ON, Canada; Medical Research Council Clinical Trials Unit, London, United Kingdom; MRC Clinical Trials Unit, London, United Kingdom; The Royal Hallamshire Hospital, Sheffield, United Kingdom; Velindre Hospital, Cardiff, United Kingdom; NCIC Clinical Trials Group, Queen's Division of Cancer Care and Epidemiology, Kingston, ON, Canada; The Christie NHS Foundation Trust, Manchester, United Kingdom; Princess Margaret Hospital and University of Toronto, Toronto, ON, Canada; Credit Valley Hospital, Mississauga, ON, Canada; Castle Hill Hospital, Hull, United Kingdom; NCIC Clinical Trials Group, Kingston, ON, Canada; Weston Park Hospital, Sheffield, United Kingdom; British Columbia Cancer Agency, Surrey, BC, Canada; CancerCare Manitoba, Winnipeg, MB, Canada; University of Texas Health Science Center at San Antonio, San Antonio, TX; Department of Radiation Oncology, Princess Margaret Hospital and University of Toronto, Toronto, ON, Canada

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Abstract Disclosures


Background: Data from the SPCG-7 study and interim analysis of this trial have demonstrated an overall survival (OS) benefit for RT when added to ADT. We present the protocol specified final analysis of PR3/PR07. Methods: Patients with locally advanced (T3/T4, N0/NX, n=1057) or organ-confined prostate cancer (T2,N0/NX, with either PSA > 40 μg/l or PSA > 20 μg/l and Gleason > 8, n=144) were randomized to lifelong ADT (bilateral orchiectomy or LHRH agonist) or ADT + RT (65-69 Gy to prostate + seminal vesicles with or without 45Gy to pelvic nodes). The primary outcome measure was OS; secondary outcomes included disease-specific survival (DSS), time to disease progression and quality of life. Final analysis was planned after 421 deaths. Results: 1,205 patients were randomized from 1995-2005, 602 to ADT alone and 603 to ADT+RT (well balanced with respect to baseline characteristics). The median follow-up is 8.0 years and 465 patients have died (260 ADT, 205 ADT+RT). Adding RT to ADT significantly reduced the risk of death (Hazard Ratio 0.70, 95% CI 0.57-0.85, p=0.001). 199 patients died of disease and/or treatment (134 on ADT alone and 65 on ADT+RT). Competing risk analysis demonstrated that patients on the ADT alone arm had a significantly higher chance of dying of disease related causes than those treated with ADT+RT (10 year cumulative disease specific death rates 15% with ADT+ RT, 26% with ADT alone, p<0.0001). The addition of RT to ADT had a small detrimental effect on late gastrointestinal toxicity and health-related quality-of-life (> grade II proctitis, 0.3% ADT alone, 1.0% ADT+RT; mean change EORTC Rectal symptoms -0.3 ADT vs 1.7 ADT + RT, p=0.54). Conclusions: Mature data indicate a sustained and substantial overall survival and disease specific survival benefit for ADT+RT in the management of patients with locally advanced prostate cancer with minimal increase in late treatment toxicity. The benefits of combined modality treatment should be discussed with all patients. Supported by NCI-US Grant CA077202, CCSRI Grants #14469 and # 015469, UK Medical Research Council Grant G9805643, UK National Cancer Research Network.