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

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.

Trial Details

NCT ID
NCT05346848
Phase
PHASE2
Sponsor
Institut Bergonié
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Association of darolutamide and EBRT
  • Association of ADT and EBRT
Locations (sample)
  • Avignon, France|43.94834,4.80892
  • Besançon, France|47.24878,6.01815
  • Bordeaux, France|44.84124,-0.58046
  • Brest, France|48.39029,-4.48628
  • Marseille, France|43.29695,5.38107

Key Eligibility Criteria

  • 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-enhance…
  • Unfavorable intermediate risk prostate cancer diagnosis defined by the NCCN Guidelines.
  • One of the following criteria is sufficient to define an unfavorable intermediate risk prostate cancer:

For full eligibility, visit ClinicalTrials.gov.

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