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Abstract

PURPOSE:

Up to 30% of patients who undergo radiation for intermediate- or high-risk localized prostate cancer relapse biochemically within 5 years. We assessed if biochemical disease-free survival (DFS) is improved by adding 6 months of androgen suppression (AS; two injections of every-3-months depot of luteinizing hormone-releasing hormone agonist) to primary radiotherapy (RT) for intermediate- or high-risk localized prostate cancer.

PATIENTS AND METHODS:

A total of 819 patients staged: (1) cT1b-c, with prostate-specific antigen (PSA) ≥ 10 ng/mL or Gleason ≥ 7, or (2) cT2a (International Union Against Cancer TNM 1997), with no involvement of pelvic lymph nodes and no clinical evidence of metastatic spread, with PSA ≤ 50 ng/mL, were centrally randomized 1:1 to either RT or RT plus AS started on day 1 of RT. Centers opted for one dose (70, 74, or 78 Gy). Biochemical DFS, the primary end point, was defined from entry until PSA relapse (Phoenix criteria) and clinical relapse by imaging or death of any cause. The trial had 80% power to detect hazard ratio (HR), 0.714 by intent-to-treat analysis stratified by dose of RT at the two-sided α = 5%.

RESULTS:

The median patient age was 70 years. Among patients, 74.8% were intermediate risk and 24.8% were high risk. In the RT arm, 407 of 409 patients received RT; in the RT plus AS arm, 403 patients received RT plus AS and three patients received RT only. At 7.2 years median follow-up, RT plus AS significantly improved biochemical DFS (HR, 0.52; 95% CI, 0.41 to 0.66; P < .001, with 319 events), as well as clinical progression-free survival (205 events, HR, 0.63; 95% CI, 0.48 to 0.84; P = .001). In exploratory analysis, no statistically significant interaction between treatment effect and dose of RT could be evidenced (heterogeneity P = .79 and P = .66, for biochemical DFS and progression-free survival, respectively). Overall survival data are not mature yet.

CONCLUSION:

Six months of concomitant and adjuvant AS improves biochemical and clinical DFS of intermediate- and high-risk cT1b-c to cT2a (with no involvement of pelvic lymph nodes and no clinical evidence of metastatic spread) prostatic carcinoma, treated by radiation. 

Author information​

Bolla M1, Maingon P2, Carrie C2, Villa S2, Kitsios P2, Poortmans PM2, Sundar S2, van der Steen-Banasik EM2, Armstrong J2, Bosset JF2, Herrera FG2, Pieters B2, Slot A2, Bahl A2, Ben-Yosef R2, Boehmer D2, Scrase C2, Renard L2, Shash E2, Coens C2, van den Bergh AC2, Collette L2.

1Michel Bolla, Centre Hospitalier Universitaire de Grenoble, Grenoble; Philippe Maingon, Georges-Francois-Leclerc Centre, Dijon; Christian Carrie, Leon Bérard Center, Lyon; Jean-François Bosset, University Hospital of Besancon-Jean Minjoz Hospital, Besancon, France; Salvador Villa, University Hospital Germans Trias I Pujol, Barcelona, Spain; Petros Kitsios, Bank of Cyprus Oncology Centre, Nicosia, Cyprus; Philip M.P. Poortmans, Radboud University Medical Center Nijmegen, Nijmegen; Elzbieta M. van der Steen-Banasik, Arnhem Radiotherapy Institute, Arnhem; Bradley Pieters, University of Amsterdam, Amsterdam; Annerie Slot, Radiotherapeutisch Instituut Friesland, Leeuwarden; Alphonsus C.M. van den Bergh, University of Groningen, Groningen, the Netherlands; Santhanam Sundar, Nottingham University Hospitals National Health Service Trust-City Hospital, Nottingham; Amit Bahl, University Hospitals Bristol National Health Service Foundation Trust-Bristol Haematology and Oncology Centre, Bristol Avon; Christopher Scrase, Ipswich Hospital National Health Service Trust, Ipswich, United Kingdom; John Armstrong, St Luke's Hospital, Dublin, Ireland; Fernanda G. Herrera, University Hospital of Lausanne, Lausanne, Switzerland; Rahamim Ben-Yosef, Rambam Health Care Campus, Haïfa, Israel; Dirk Boehmer, Charite-Universitaetsmedizin Berlin-Campus Mitte, Berlin, Germany; Laurette Renard, Cliniques Universitaires Saint Luc; Emad Shash, Corneel Coens, and Laurence Collette, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; and Emad Shash, Cairo University, Cairo, Egypt. mbolla@chu-grenoble.fr.

2Michel Bolla, Centre Hospitalier Universitaire de Grenoble, Grenoble; Philippe Maingon, Georges-Francois-Leclerc Centre, Dijon; Christian Carrie, Leon Bérard Center, Lyon; Jean-François Bosset, University Hospital of Besancon-Jean Minjoz Hospital, Besancon, France; Salvador Villa, University Hospital Germans Trias I Pujol, Barcelona, Spain; Petros Kitsios, Bank of Cyprus Oncology Centre, Nicosia, Cyprus; Philip M.P. Poortmans, Radboud University Medical Center Nijmegen, Nijmegen; Elzbieta M. van der Steen-Banasik, Arnhem Radiotherapy Institute, Arnhem; Bradley Pieters, University of Amsterdam, Amsterdam; Annerie Slot, Radiotherapeutisch Instituut Friesland, Leeuwarden; Alphonsus C.M. van den Bergh, University of Groningen, Groningen, the Netherlands; Santhanam Sundar, Nottingham University Hospitals National Health Service Trust-City Hospital, Nottingham; Amit Bahl, University Hospitals Bristol National Health Service Foundation Trust-Bristol Haematology and Oncology Centre, Bristol Avon; Christopher Scrase, Ipswich Hospital National Health Service Trust, Ipswich, United Kingdom; John Armstrong, St Luke's Hospital, Dublin, Ireland; Fernanda G. Herrera, University Hospital of Lausanne, Lausanne, Switzerland; Rahamim Ben-Yosef, Rambam Health Care Campus, Haïfa, Israel; Dirk Boehmer, Charite-Universitaetsmedizin Berlin-Campus Mitte, Berlin, Germany; Laurette Renard, Cliniques Universitaires Saint Luc; Emad Shash, Corneel Coens, and Laurence Collette, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; and Emad Shash, Cairo University, Cairo, Egypt