Spots Global Cancer Trial Database for Hormone Therapy in Treating Patients With Advanced Prostate Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Hormone Therapy in Treating Patients With Advanced Prostate Cancer
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 ID: NCT00003026
Conditions
Study Description
Brief Summary: 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.
Detailed Description: OBJECTIVES: * 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.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Institut Jules Bordet, Brussels (Bruxelles), , Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
Universitair Ziekenhuis Gent, Ghent, , Belgium
Virga Jesse Hospital, Hasselt, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
Rambam Medical Center, Haifa, , Israel
St. Luke's Hospital and Medical School, Guardamangia, , Malta
Groot Ziekengasthuis 's-Hertogenbosch, 's-Hertogenbosch, , Netherlands
Onze Lieve Vrouwe Gasthuis, Amsterdam, , Netherlands
Academisch Medisch Centrum, Amsterdam, , Netherlands
Academisch Ziekenhuis Groningen, Groningen, , Netherlands
Academisch Ziekenhuis Maastricht, Maastricht, , Netherlands
St. Elisabeth Ziekenhuis, Tilburg, , Netherlands
Medical Radiological Research Center, Obninsk, , Russian Federation
Marmara University Hospital, Istanbul, , Turkey
City General Hospital, Stoke-On-Trent, England, United Kingdom
Contact Details
Name: Michel Bolla, MD
Affiliation: CHU de Grenoble - Hopital de la Tronche
Role: STUDY_CHAIR
Name: T. M. de Reijke, MD, PhD
Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
