OncoMatch/Clinical Trials/NCT06177015
Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC
Is NCT06177015 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Darolutamide continuous and Darolutamide intermittent for metastatic prostate cancer.
Treatment: Darolutamide continuous · Darolutamide intermittent — To evaluate the efficacy and safety of intermittent use of darolutamide compared to long-term use in combination with ADT and docetaxel in the treatment of mHSPC patients.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: second-generation androgen receptor inhibitor
Prior treatment with: a) Second-generation ARis or other experimental ARis
Cannot have received: CYP17 enzyme inhibitor (abiraterone acetate, oral ketoconazole)
Prior treatment with: b) CYP17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole for anti-tumor treatment of prostate cancer
Cannot have received: chemotherapy
Prior treatment with: c) Chemotherapy ... prior to randomization for prostate cancer
Cannot have received: immunotherapy
Prior treatment with: c) ... immunotherapy prior to randomization for prostate cancer
Cannot have received: radiation therapy
Exception: within 2 weeks before starting 6 months of darolutamide + docetaxel + ADT treatment
Received radiotherapy within 2 weeks before starting 6 months of darolutamide + docetaxel + ADT treatment
Lab requirements
Blood counts
Hemoglobin ≥ 90g/L; ANC ≥ 1.5×10^9/L; Platelets ≥ 80×10^9/L
Kidney function
Serum creatinine ≤ 2.0×ULN
Liver function
ALT and AST ≤ 2.5 × ULN; Total bilirubin ≤ 2.0 × ULN
Good bone marrow, kidney, and liver function: (1) Hematological examination ... Hemoglobin (HB) ≥ 90g/L; Absolute neutrophil count (ANC) ≥ 1.5×10^9/L; Platelets (PLT) ≥ 80×10^9/L; (2) Blood biochemistry ... ALT and AST ≤ 2.5 × ULN; Total bilirubin (TBIL) ≤ 2.0 × ULN; Serum creatinine (Cr) ≤ 2.0×ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06177015 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior second-generation androgen receptor inhibitor, CYP17 enzyme inhibitor, chemotherapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger and at least 40 years old.
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