Hormone Therapy in Treating Patients With Advanced Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00003026|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 2, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: bicalutamide Drug: flutamide Drug: triptorelin Radiation: radiation therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||966 participants|
|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|
|Actual Primary Completion Date :||September 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003026
|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)|