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

ConditionProstate Cancer

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexMale

Age18+

SponsorInstitut Bergonié

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18,

Histological diagnosis of prostate malignancy cancer

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 assessment by PET-Scan is allowed as per investigator judgement),

Unfavorable intermediate risk prostate cancer diagnosis defined by the NCCN Guidelines.

Disqualifiers

Stage T3b-T4 prostate cancer by clinical examination or radiologic evaluation,

Patients with Gleason score ≥8,

Patients with PSA >20 ng/ml,

Presence of loco-regional or distant metastasis,

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

62 Participants

are divided into 2 treatment groups

Group A: Experimental Arm A: combination of radiotherapy and darolutamideExperimental treatment 1 intervention

Group B: Standard Arm B: combination of radiotherapy and androgen deprivation therapyOther 1 intervention