OncoMatch/Clinical Trials/NCT06631521
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
Is NCT06631521 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Darolutamide and Relugolix for prostate ca.
Treatment: Darolutamide · Relugolix — The goal of this clinical trial is to determine the safety and feasibility of a new combination of darolutamide and relugolix as neoadjuvant therapy preceding radical prostatectomy (RP) for high-risk prostate cancer (PCa) in adult males.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Participants who have had chemotherapy or radiotherapy within 4 weeks prior to planned cycle 1 day 1 of study treatment.
Cannot have received: radiation therapy
Participants who have had chemotherapy or radiotherapy within 4 weeks prior to planned cycle 1 day 1 of study treatment.
Cannot have received: anti-neoplastic intervention or experimental antineoplastic therapy
Participants who have received anti-neoplastic intervention or experimental antineoplastic therapy within 14 days of planned cycle 1 day 1 of study therapy.
Cannot have received: investigational agents
Participants who are receiving any other investigational agents.
Cannot have received: androgen receptor inhibitor (darolutamide, relugolix, LHRH agonist, LHRH antagonist, abiraterone, apalutamide, enzalutamide)
Exception: prior bicalutamide that was discontinued ≥14 days prior to planned cycle 1 day 1 is allowed
Participants who have previously received darolutamide, relugolix, LHRH agonist/antagonist or another novel androgen blocking therapy (abiraterone, apalutamide, enzalutamide) within 1 year are excluded (prior bicalutamide that was discontinued ≥14 days prior to planned cycle 1 day 1 is allowed).
Lab requirements
Blood counts
ANC ≥1,500/mm3 or ≥1.5 x 10^9/L; Platelets ≥100,000/mm3 or ≥100 x 10^9/L; Hemoglobin ≥8 g/dL (may have been transfused)
Kidney function
Estimated creatinine clearance ≥30 mL/min as calculated using the Cockcroft-Gault equation
Liver function
Total serum bilirubin <1.5 x ULN, less than 2.0 x ULN if suspected Gilbert's syndrome; AST and ALT less than 2.5 x ULN
Participants must have adequate organ and marrow function as below: 1. Absolute neutrophil count (ANC) ≥1,500/mm3 or ≥1.5 x 10^9/L; 2. Platelets ≥100,000/mm3 or ≥100 x 10^9/L; 3. Hemoglobin ≥8 g/dL (may have been transfused). 4. Estimated creatinine clearance ≥30 mL/min as calculated using the Cockcroft-Gault equation. 5. Total serum bilirubin <1.5 x upper limit of normal (ULN), less than 2.0 x ULN if suspected Gilbert's syndrome; 6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 x ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- AdventHealth Orlando · Orlando, Florida
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