Hormone Therapy in Treating Patients With Advanced Prostate Cancer
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using triptorelin may fight prostate cancer by reducing the production of androgens.
PURPOSE: Randomized phase III trial to compare the effectiveness of long-term hormone therapy and triptorelin with no further treatment in treating patients who have advanced prostate cancer previously treated with radiation therapy and 6 months of androgen suppression.
|Prostate Cancer||Drug: bicalutamide Drug: flutamide Drug: triptorelin Radiation: radiation therapy||Phase 3|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Long Term Adjuvant Hormonal Treatment With LHRH Analogue Versus No Further Treatment in Locally Advanced Prostatic Carcinoma Treated by External Irradiation and a Six Months Combined Androgen Blockade - A Phase III Study|
|Study Start Date:||April 1997|
|Primary Completion Date:||September 2001 (Final data collection date for primary outcome measure)|
- Determine the best hormonal scheme to be associated with pelvic radiotherapy in the curative management of prostatic carcinoma for hormonal treatment with regards to treatment outcome (overall survival, clinical disease free survival, local regional control), quality of life (treatment side effects, sexual function), and health economy (cost effectiveness ratio).
OUTLINE: This is a randomized, multicenter study.
Patients receive external radiation for 5 weeks, followed by a pelvic boost given for 2 weeks and a 6 month combined androgen blockage initiated at the onset of external irradiation. Flutamide (Eulexin) or bicalutamide (Casodex) may be used as the antiandrogens. Antiandrogen treatment starts 1 week before the first injection of triptorelin.
Patients are then randomized to one of two treatment arms.
- Arm I: Patients receive no further treatment.
- Arm II: Patients receive antiandrogen for 2.5 years plus and LHRH analogue (triptorelin) administered every 3 months. Patients then continue the LHRH analogue alone for an additional 2.5 years in the absence of disease progression.
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 966 patients will be accrued over 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003026
|Institut Jules Bordet|
|Brussels (Bruxelles), Belgium, 1000|
|Academisch Ziekenhuis der Vrije Universiteit Brussel|
|Brussels, Belgium, 1090|
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Universitair Ziekenhuis Gent|
|Ghent, Belgium, B-9000|
|Virga Jesse Hospital|
|Hasselt, Belgium, 3500|
|Leuven, Belgium, B-3000|
|Rambam Medical Center|
|Haifa, Israel, 31096|
|St. Luke's Hospital and Medical School|
|Guardamangia, Malta, MSD 07|
|Groot Ziekengasthuis 's-Hertogenbosch|
|'s-Hertogenbosch, Netherlands, 5200 ME|
|Onze Lieve Vrouwe Gasthuis|
|Amsterdam, Netherlands, 1091 HA|
|Academisch Medisch Centrum|
|Amsterdam, Netherlands, 1105 AZ|
|Academisch Ziekenhuis Groningen|
|Groningen, Netherlands, 9700 RB|
|Academisch Ziekenhuis Maastricht|
|Maastricht, Netherlands, 6202 AZ|
|St. Elisabeth Ziekenhuis|
|Tilburg, Netherlands, 5022 GC|
|Medical Radiological Research Center|
|Obninsk, Russian Federation|
|Marmara University Hospital|
|Istanbul, Turkey, 81190|
|City General Hospital|
|Stoke-On-Trent, England, United Kingdom, ST4 6QG|
|Study Chair:||Michel Bolla, MD||CHU de Grenoble - Hopital de la Tronche|
|Study Chair:||T. M. de Reijke, MD, PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|