Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)

A vizsgálat adatai

Ki végzi

AstraZeneca

Azonosító

NCT07711002EU 2026-526275-38-00

A regiszteradat frissítve

2026. október 15.

Eredeti leírás

The primary objective of this study is to measure efficacy of saruparib + physician's choice of ARPI compared with placebo + ARPI in men with metastatic hormone-sensitive prostate cancer (mHSPC) who have previously received docetaxel chemotherapy or a prostate-specific membrane antigen (PSMA)-directed lutetium-177 radioligand therapy with no evidence of disease progression and PSA ≥ 0.2 ng/mL.A teljes eredeti leírásKevesebb

A Randomized, Double-Blind, Placebo-Controlled, 2-Cohort, Phase III Study of Saruparib Combined With Physician's Choice of Androgen Receptor Pathway Inhibitor in Patients With Metastatic Hormone-Sensitive Prostate Cancer, Previously Treated With Docetaxel or PSMA-directed 177Lutetium-Containing Therapy Without Disease Progression, and With Prostate-Specific Antigen ≥ 0.2 ng/mL: EvoPAR-Prostate05

The primary objective of this study is to measure efficacy of saruparib + physician's choice of ARPI compared with placebo + ARPI in men with metastatic hormone-sensitive prostate cancer (mHSPC) who have previously received docetaxel chemotherapy or a prostate-specific membrane antigen (PSMA)-directed lutetium-177 radioligand therapy with no evidence of disease progression and PSA ≥ 0.2 ng/mL.

Bevonási feltételek: Participant must be ≥ 18 at the time of signing the informed consent; Histologically documented diagnosis of prostate adenocarcinoma that is de novo or recurrent and hormone-sensitive; Metastatic disease confirmed prior to initiation of previous treatment with docetaxel or Lu-PSMA-containing regimens for mHSPC; Previous treatment with docetaxel (IV, Q3w)- or Lu-PSMA (IV, Q6w) with last dose within past 6 months; Participants must have the following:; Must be receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy; Had no evidence of disease progression; Had all toxicities related to docetaxel- or Lu-PSMA-containing treatment (except for alopecia and peripheral neuropathy) resolved to CTCAE Grade 1 or lower; PSA ≥ 0.2 ng/mL within 14 days prior to randomization; Serum testosterone < 1.7 nmol/L or 50 ng/dL; Palliative radiotherapy for symptoms management will be permitted and is to be completed at least 4 weeks prior to randomization for wide field radiation therapy and at least 2 weeks prior to randomization for limited field radiation therapy; Provision of a FFPE tumor tissue sample and a blood sample (for ctDNA); Confirmed HRRm, HRD and PTEN status; Adequate organ and bone marrow function; Minimum life expectancy of 6 months; Male, assigned at birth, inclusive of all gender identities; Contraceptive use by participants or participant partners should be consistent with local regulations; Capable of giving signed informed consent; - -.

Kizáró feltételek: Major surgical procedure or significant traumatic injury within 4 weeks of the first dose or an anticipated need for major surgery during the study; Switched ARPI agent in previous treatment for mHSPC due to disease progression. Note: if the ARPI agent was switched due to any reason other than disease progression and switch was prior to ICF signature, participants will be eligible; Any prior treatment with a PARPi or platinum chemotherapy; Hypersensitivity to saruparib, ARPI or any excipients of these products or any contraindication or restriction based on the local label; Any known predisposition to bleeding (eg, active peptic ulceration, recent [within6 months] hemorrhagic stroke, proliferative diabetic retinopathy; History of MDS/AML or with features suggestive of MDS/AML; History of another primary malignancy, with some exceptions; Any chronic gastrointestinal diseases or conditions including inability to swallow the formulated product that would preclude adequate absorption of any study drug; History of seizure or predispose to seizure, including any history of loss of consciousness or transient ischemic attack within 12 months of enrolment; Serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection; Any history of persisting (> 2 weeks) severe cytopenia due to any cause (eg, ANC< 0.5 × 10\^9/L or platelets < 50 × 10\^9/L); Spinal cord compression or brain metastases unless asymptomatic and stable; - -.

ClinicalTrials.gov NCT07711002 · EU CTIS 2026-526275-38-00