OncoMatch/Clinical Trials/NCT05873192
Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer
Is NCT05873192 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for prostate cancer.
Treatment: ADT · Enzalutamide · Talazoparib · Degarelix · Luprolide — To learn about the effectiveness of adding talazoparib to the standard of care treatment combination of androgen ablation therapy (hormone therapy, also known as ADT) and enzalutamide in patients with prostate cancer that has spread into the lymph nodes.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Patients who have had prior chemotherapy... will be excluded.
Cannot have received: experimental agents for prostate cancer
Patients who have had... experimental agents for prostate cancer... will be excluded.
Cannot have received: androgen deprivation therapy
Exception: receiving >4 weeks of prior ADT will be excluded; up to 6 weeks permitted if biopsy specimen collected prior to initiation of ADT is made available
patients receiving >4 weeks of prior ADT will be excluded. Prior hormonal therapy (LHRH agonist/antagonist with or without first-generation antiandrogen) up to 6 weeks is permitted, provided any tumor biopsy specimen collected prior to initiation of ADT is made available for biomarker studies.
Cannot have received: estrogens
Treatment with estrogens... in the 4 weeks prior to scheduled Day 1 of treatment.
Cannot have received: cyproterone acetate
Treatment with... cyproterone acetate... in the 4 weeks prior to scheduled Day 1 of treatment.
Cannot have received: glucocorticoids
Exception: at a dose >10 mg/day of prednisone equivalent in the 4 weeks prior to scheduled Day 1 of treatment
Treatment with... glucocorticoids (at a dose >10 mg/day of prednisone equivalent) in the 4 weeks prior to scheduled Day 1 of treatment.
Lab requirements
Blood counts
hemoglobin ≥10 g/dL, ANC ≥1,500/mm3, platelet count ≥100,000/mm3; no features suggestive of MDS/AML on peripheral blood smear
Kidney function
creatinine <1.5 x ULN or creatinine clearance ≥30 mL/min (measured or calculated with the Cockcroft-Gault Equation)
Liver function
total bilirubin ≤1.5 x ULN (≤3 × ULN in subjects with Gilbert's disease), and AST/ALT ≤2.5 x ULN
adequate bone marrow function defined as hemoglobin ≥10 g/dL, an absolute peripheral neutrophil count (ANC) of ≥1,500/mm3 and platelet count of ≥100,000/mm3; no features suggestive of MDS/AML on peripheral blood smear; adequate hepatic function defined with a total bilirubin of ≤1.5 x upper limit of normal (ULN) (≤3 × ULN in subjects with Gilbert's disease), and AST/ALT ≤2.5 x ULN; adequate renal function defined as creatinine <1.5 x ULN or creatinine clearance ≥30 mL/min (measured or calculated with the Cockcroft-Gault Equation).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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