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.
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.
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,
Institut Bergonié
Lead sponsor
Bayer
Collaborator