RecruitingPhase 2NCT05346848

Randomized Phase II Trial on Short Term Darolutamide Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer

A Randomized Non-comparative Phase II Multicentric Trial on Short Term Darolutamide (ODM-201) Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer

Sponsor

Institut Bergonié

Enrollment

62 participants

Start Date

Feb 24, 2023

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

Summary

Randomized non-comparative phase II trial to assess the preliminary signs of antitumor activity of darolutamide plus radiation therapy in patients with unfavorable intermediate risk prostate cancer.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a short course of a hormone-blocking drug called darolutamide alongside radiation therapy works better than radiation alone for men with intermediate-risk prostate cancer that hasn't spread. **You may be eligible if...** - You are 18 or older and have been diagnosed with intermediate-risk prostate cancer (no spread detected) - Your cancer is classified as "unfavorable intermediate risk" based on standard guidelines (e.g., Gleason score 7 with 4+3 pattern, or certain PSA and stage criteria) - You have not previously been treated for prostate cancer - You have a life expectancy of at least 5 years and can tolerate radiation therapy **You may NOT be eligible if...** - Your cancer is high-risk (Gleason 8+, PSA over 20, or stage T3b–T4) - You have any confirmed spread of cancer to lymph nodes or distant organs - You have previously had androgen deprivation therapy, surgery, or radiation for prostate cancer - You have significant heart problems, uncontrolled diabetes, or recent stroke - You are unable to swallow tablets 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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Interventions

DRUGAssociation of darolutamide and EBRT

Darolutamide will be taken orally at a fixed dose of 600 mg twice daily (1200 mg), on a continuous basis, for a maximum of 6 months. Darolutamide will start at Day 1. \- External Beam Radiotherapy (EBRT) will start two months after treatment initiation. All patients will be treated with standard schedules: * 78 Gy with classical 2 Gy/fractions, 5 days/7 * Or 60 Gy with 3 Gy/fractions, 5 days/7 * Use of IMRT and IGRT is mandatory * Clinical Target Volume Definition according to GETUG Guidelines * Organ at risk dose constraints according to RECORAD

DRUGAssociation of ADT and EBRT

Treatment by Androgen Deprivation Therapy (ADT) will be prescribed as per market authorization and following investigator judgement. ADT treatment will consist on: * Either LH-RH agonist injection given every 3 months for 6 months, or once for 6 months, * Either LH-RH antagonist given monthly for 6 months External Beam Radiotherapy (EBRT) will start two months after treatment initiation. All patients will be treated by high dose irradiation in stereotactic conditions: * 78 Gy with classical 2 Gy/fractions, 5 days/7 * Or 60 Gy with 3 Gy/fractions, 5 days/7 * Use of IMRT and IGRT is mandatory * Clinical Target Volume Definition according to GETUG Guidelines * Organ at risk dose constraints according to RECORAD