OncoMatch/Clinical Trials/NCT05346848
Randomized Phase II Trial on Short Term Darolutamide Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer
Is NCT05346848 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Association of darolutamide and EBRT and Association of ADT and EBRT for prostate cancer.
Treatment: Association of darolutamide and EBRT · Association of ADT and EBRT — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage UNFAVORABLE INTERMEDIATE RISK, T2B (CLINICAL OR RADIOLOGICAL), IT3A (IF GLEASON SCORE IS 6 AND PSA < 20) (NCCN Guidelines)
Unfavorable intermediate risk prostate cancer diagnosis defined by the NCCN Guidelines. Stage T3b-T4 prostate cancer by clinical examination or radiologic evaluation [excluded].
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: androgen deprivation
Previous prostate cancer treated by androgen deprivation
Cannot have received: chemotherapy
Previous prostate cancer treated by chemotherapy
Cannot have received: surgery
Exception: except pelvic lymph-nodes dissection
Previous prostate cancer treated by surgery; Major surgery within 4 weeks prior enrolment except pelvic lymph-nodes dissection
Cannot have received: radiotherapy
Previous prostate cancer treated by radiotherapy
Cannot have received: orchiectomy
Patients with previous orchiectomy
Cannot have received: androgens, anti-androgens, estrogens, or progestational agents
Patients actively receiving or having received within 6 months prior enrollment any concurrent androgens, anti-androgens, estrogens, or progestational agents
Cannot have received: other hormonal agents (ketoconazole, finasteride, dutasteride)
Patients having received ketoconazole, finasteride or dutasteride within 30 days of inclusion
Lab requirements
Blood counts
adequate organ function defined by all the following laboratory values
Kidney function
adequate organ function defined by all the following laboratory values
Liver function
adequate organ function defined by all the following laboratory values
Patients with adequate organ function defined by all the following laboratory values
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify