Study on the Role of Hormonal Treatment for Two Dosage Levels of Prostate Radiation Therapy Versus Prostate Radiation Therapy Alone (NCT00223145)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Centre de Recherche Clinique du CHUS โ Sherbrooke, Quebec
Age range: 18 Years to 80 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Centre de Recherche Clinique du CHUS โ Sherbrooke, Quebec
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described โ Homewood, Alabama
- Stereotactic Ablative Radiation Therapy for Prostate Cancer โ Charleston, South Carolina
- A Study of Stereotactic Body Radiation Therapy (SBRT) Without Androgen Deprivation Therapy (ADT) in People With Unfavorable Intermediate-Risk Prostate Cancer โ Basking Ridge, New Jersey
- A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer โ Phoenix, Arizona
- Neoadjuvant Enoblituzumab (MGA271) in Men With Localized Intermediate and High-Risk Prostate Cancer โ Baltimore, Maryland
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.