OncoMatch/Clinical Trials/NCT06177015
Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC
Is NCT06177015 recruiting? Yes, currently enrolling (May 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
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
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.
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