Post-operative or Early Salvage XRT and ADT for High Risk PCa
RATIONALE: Conformal radiation therapy uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor. Giving conformal external-beam radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Androgens can cause the growth of prostate cancer cells. Hormone therapy, such as leuprolide acetate, may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective when given together with or without hormone therapy in treating patients with prostate cancer who have undergone surgery.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with hormone therapy in treating patients who have undergone surgery for stage I, stage II, or stage III prostate cancer.
|Prostate Cancer||Drug: antiandrogen therapy Drug: leuprolide acetate Radiation: 3-dimensional conformal radiation therapy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Immediate or Early Salvage Post-operative External Radiotherapy Combined With Concomitant and Adjuvant Hormonal Treatment Versus Immediate or Early Salvage Postoperative External Radiotherapy Alone in pT3a-b R0-1 cN0M0 / pT2R1 cN0M0, Gleason Score 5-10 Prostatic Carcinoma. A Phase III Study|
- Biochemical progression-free survival
- Clinical progression-free survival
- Distant-metastases-free survival
- Overall survival
- Quality of life as assessed by QLQ-C30 and QLQ-PR25 at baseline and at 6 months, 1 year, 2 years, and 5 years after treatment
- Acute and late toxicity according to NCI CTCAE version 3.0
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I
Patients undergo post-operative conformal external beam irradiation for 6.5 weeks.
Radiation: 3-dimensional conformal radiation therapy
Experimental: Arm II
Beginning on day -5 to -3, patients receive an antiandrogen for 2-4 weeks. Beginning on day 0, patients receive leuprolide acetate subcutaneously once (6-month depot) and undergo conformal external beam irradiation 5 times weekly for 6.5 weeks.
Drug: antiandrogen therapy
Given systemicallyDrug: leuprolide acetate
Given subcutaneouslyRadiation: 3-dimensional conformal radiation therapy
- To investigate the potential benefit of post-operative radiotherapy with vs without a combined and adjuvant treatment consisting of short-term androgen suppression for improving the biochemical progression-free survival of patients who have undergone radical prostatectomy for stage I-III prostate cancer.
OUTLINE: This is a multicenter study. Patients are stratified according to institution, pathological stage (pT2R1 vs pT3R0 vs pT3R1), Gleason sum (≤ 3+4 vs ≥ 4+3), and WHO performance status (0 vs 1). Within 3 months after radical surgery, patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo post-operative conformal external beam irradiation for 6.5 weeks.
- Arm II: Beginning between days -5 to -3, patients receive an antiandrogen for 2-4 weeks. Beginning on day 0, patients receive leuprolide acetate subcutaneously once (6-month depot) and undergo conformal external beam irradiation 5 times weekly for 6.5 weeks.
Patients undergo quality of life assessments periodically.
After completion of study treatment, patients are followed up every 6 months for 5 years and then yearly thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949962
|European Organization for Research and Treatment of Cancer|
|Grenoble, France, 38043|
|Principal Investigator:||Michel Bolla, MD||CHU de Grenoble - Hopital de la Tronche|