NCT00223171Active, not recruitingPhase 3
Duration of Androgen Blockade Combined With Pelvic Irradiation in Prostate Cancers
Randomized, Multicentre, Phase III Study: Assessment of the Duration of Androgen Blockade Combined With Pelvic Irradiation in High-risk Prostate Cancers
Source: ClinicalTrials.gov · Last updated 27 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 630 (actual)
- First submitted
- 13 Sept 2005
- Start date
- Oct 2000
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Université de Sherbrooke
- Diseases
- Prostate cancer
- NCT number
- NCT00223171
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 630
- From Oct 2000 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe medical or psychiatric problems that could compromise study compliance.
- Chronic hepatic disease, abnormal hepatic functions, i.e. aspartate aminotransferase, alanine aminotransferase \> 1.5 times the upper normal limit.
Who the study is looking for
- To have at least one of the following three risk factors:
- Tumour classified T3 or T4
- Gleason score 8-10
- Prostate-specific antigen (PSA) level \> 20
- Performance status score of 0-1.
- Patients must sign a consent form before the start of the study.
- No evidence of regional disease: clinically negative regional adenopathies are revealed by imaging (computed axial tomography \[CAT\] scan, magnetic resonance imaging \[MRI\], lymphography) or surgical staging or negative pelvic node dissection.
- No distant metastasis. These patients must all have a negative bone scan 12 weeks prior to randomization.
- Hormonal therapy is allowed up to a maximum of two months before the consent form is signed, as long as the initial work-up was done, including having the requested deadlines respected.
- Patients with a previous history of cancer are eligible on the condition that they have not had any disease progression for more than five years.
- The patient must be available for treatments and follow-up visits.
- Treatments must start in the three weeks following randomization.
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre de Recherche Clinique du CHUS Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.