Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Association of darolutamide and EBRT · 1 trial · 1 indication
Biological response is defined as a PSA concentration \<=0.1ng/mL according to Phoenix's criteria
| Arm | Type | Description |
|---|---|---|
| Experimental Arm A: combination of radiotherapy and darolutamide | EXPERIMENTAL | Patients with unfavorable intermediate risk prostate cancer will be treated with darolutamide for a maximum of 6 months combined with external beam radiotherapy |
| Standard Arm B: combination of radiotherapy and androgen deprivation therapy | OTHER | Patients with unfavorable intermediate risk prostate cancer will be treated with androgen deprivation therapy (ADT) as per market authorization combined with external beam radiotherapy |
| Name | Type | Description |
|---|---|---|
| Association of darolutamide and EBRT | DRUG | 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 |
| Association of ADT and EBRT | DRUG | 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 |
Inclusion Criteria: 1. Age ≥ 18, 2. Histological diagnosis of prostate malignancy cancer 3. Cancer without loco-regional or distant metastasis (tumor assessment must comprise at least Pelvic MRI AND thoraco-abdomino-pelvic contrast-enhanced CT-Scan AND Bone Scintigraphy. (Note that additional asses...
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