OncoMatch/Clinical Trials/NCT06631521
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
Is NCT06631521 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Endocrine / hormonal
Cancer type
Prostate Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06631521 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, radiation therapy, anti-neoplastic intervention or experimental antineoplastic therapy disqualifies patients from enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
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 qualifyRelated pages