NCT00223145Active, not recruitingPhase 3
Study on the Role of Hormonal Treatment for Two Dosage Levels of Prostate Radiation Therapy Versus Prostate Radiation Therapy Alone
Randomized, Multicentre, Phase III Study in Patients With Intermediate-risk T1 T2 Prostate Adenocarcinomas, to Verify the Role of Six Months of Total Androgen Blockade for Two Dosage Levels of Prostate Radiation Therapy (70 Gy and 76 Gy) Versus Prostate Radiation Therapy Alone at 76 Gy
Source: ClinicalTrials.gov · Last updated 27 Jan 2025
Brief summary (registry, in English)
The hypothesis of the proposed study would be that, due to the six months of total androgen blockade, which would include neoadjuvant hormonal therapy for four months and concomitant hormonal therapy for two months with irradiation, the investigators could reduce local failure rates for these two dosage levels, namely 70 Gy and 76 Gy. Since increasing the dose to the prostate also seems to reduce local relapse rates, the results of the two hormonal therapy groups would be compared with the results of prostate irradiation at doses of 76 Gy. This study would verify the possibility of compensating a six Gy dosage increase of radiation therapy with six months of hormonal therapy between the 70 Gy and 76 Gy groups who received hormonal therapy, and also match these results with a dose escalation to the prostate of 76 Gy. In the future, this could result in more therapeutic choices, such as reducing the doses of radiation therapy and, consequently, its related complications, if hormonal therapy proves to be beneficial; or rather, to continue in the direction of dose escalation for this intermediate-risk patient group, everything being correlated to the side effects of hormonal therapy and irradiation.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (actual)
- First submitted
- 13 Sept 2005
- Start date
- Dec 2000
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Abdenour Nabid
- Diseases
- Prostate cancer
- NCT number
- NCT00223145
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 600
- From Dec 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 may compromise study compliance
- Chronic hepatic disease; abnormal hepatic function, i.e. aspartate aminotransferase and alanine aminotransferase \> 1.5 times the upper normal limit.
Who the study is looking for
- Patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason score that is less than or equal to 6, as well as a prostate-specific antigen (PSA) between 10-20 (intermediate risk) or patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason score that is equal to 7, as well as a PSA equal to or less than 20 (intermediate risk).
- Performance status score of 0-1
- Patients must sign a consent form before starting the study.
- No evidence of regional disease
- Patients with a previous history of cancer are eligible on the condition that they have been disease-free for more than five years.
- Non-invasive epidermoid cancers of the skin are eligible.
- The patient must be available for treatments and follow-up visits.
- No evidence of metastatic disease, confirmed by a negative bone scan.
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.