RecruitingPhase 3NCT05019846

SRT Versus SRT+ADT in Prostate Cancer

Stereotactic Prostate Radiotherapy With or Without Androgen Deprivation Therapy, a Phase III, Multi-institutional Randomized-controlled Trial. The SPA Trial.

Sponsor

Marco Lorenzo Bonu

Enrollment

310 participants

Start Date

Sep 30, 2021

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

Summary

To clarify the role of short-term Androgen deprivation therapy (ADT) in the context of intermediate unfavorable and a subclass of high-risk patients treated with prostate Stereotactic radiotherapy (SRT). In intermediate unfavorable risk group, when choosing standard external beam radiotherapy, short term ADT is superior in terms of biochemical disease free survival (bDFS) to EBRT alone. In high risk disease, results of the combination therapy are even more clear. Prostate SRT has been endorsed as option for primary radical treatment for prostate cancer. In such patients, the benefit of ADT is still unknown and the decision is left to clinical judgement. For these reasons, it seems to be relevant to propose a randomized, open label, phase III clinical trial of prostate SBRT + 6 months ADT versus prostate SBRT alone in intermediate unfavorable and a subgroup of high risk prostate cancer patients.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study compares salvage radiation therapy (SRT) alone versus radiation therapy combined with hormone therapy (ADT) for men with prostate cancer that is at intermediate-to-high risk. Researchers want to know if adding hormone therapy improves outcomes. **You may be eligible if...** - You have prostate cancer confirmed by biopsy (at least 10 cores taken) - You fall into the intermediate-unfavorable or certain high-risk groups based on PSA level, Gleason score, and tumor stage - You have had a prostate MRI for staging - You have not previously received radiation or hormone therapy for prostate cancer **You may NOT be eligible if...** - Your prostate cancer is low-risk - You have already received prior radiation or hormone therapy - You have significant other medical conditions that could interfere with treatment - Your cancer has spread beyond the prostate or regional lymph nodes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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