A Phase 3 interventional study of Androgen blockade + radiation therapy in Prostate Cancer, sponsored by Université de Sherbrooke. Active, not recruiting at 1 site in Canada. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by Université de Sherbrooke · Phase 3, Interventional, and Treatment
The objective of this study is to use as a reference the 36-month duration of hormonal therapy according to the European Organization for Research of the Treatment of Cancer (EORTC protocol 22863) : namely one-month of total androgen blockade followed by a luteinizing hormone releasing hormone (LHRH) agonist, all for three years, combined with pelvic and prostate irradiation; this arm is currently considered to be a standard for high-risk prostate cancers. The proposed study intends to challenge the duration of hormonal therapy and verify whether the five-year outcomes in favour of combined treatment in regard to survival (79% versus 62%) and local control (85% versus 48%) can be transposed for hormonal therapy that is half as long, namely 18 months, with the possibility of hormone salvage therapy in the event of biochemical and/or clinical failure (local, regional, or distant); this applies to both arms. The proposed study will compare survival in the two groups and evaluate in each one the total duration of initial hormonal therapy, followed by initial hormonal therapy combined with salvage hormonal therapy, the duration of salvage hormonal therapy until hormonal therapy resistance, and the side effects of this hormonal therapy, with everything being related to an assessment of the quality of life of these patients.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 630 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
To have at least one of the following three risk factors:
Exclusion Criteria:
Androgen blockade : 36 months of androgen blockade : bicalutamide 50 mg die for one month, goserelin 10.8 mg x 12 Q 3 months + radiation therapy : pelvis 44 grays , prostate 70 grays (2 grays/fraction)
Drug: Androgen blockade + radiation therapy
Androgen blockade 18 months : bicalutamide 50 mg die for one month, goserelin 10.8 mg x 6 Q 3 months + radiation therapy ( pelvis 44 grays , prostate 70 grays ,2 grays/fraction)
Drug: Androgen blockade + radiation therapy
Androgen blockade + radiation therapy
Specific survival
Time frame: 10 years
Overall survival
Time frame: 10 years
Treatment morbidity induced versus quality of life based on duration of hormonal therapy
Time frame: 10 years
Disease-free survival
Time frame: 10 years
Site of tumour relapse
Time frame: 10 years
Interval until first biochemical failure
Time frame: 10 years
Interval until second biochemical failure during salvage androgen suppression (hormone-resistant tumour)
Time frame: 10 years
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Université de Sherbrooke