Find More Trials

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 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

About This Trial

This clinical trial is testing whether adding an experimental pill called saruparib to standard hormone treatment works better than standard treatment alone to slow or stop cancer growth.
It is for men with advanced prostate cancer that has spread to other parts of the body but still responds to hormone-blocking therapy.
To qualify, you must have completed chemotherapy or a specific targeted radiation treatment within the last six months without your cancer worsening, and your PSA level must still be detectable.
Before joining, you should know that you will be randomly assigned to receive either the study drug or an inactive dummy pill (placebo), taken alongside standard hormone medicine.
You will also need to provide blood and previous tumor tissue samples so doctors can check for specific genetic features.

More Information

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.

Who Can Enroll

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This clinical trial is testing whether adding an experimental pill called saruparib to standard hormone treatment works better than standard treatment alone to slow or stop cancer growth.

Study Details

Start Date: September 15, 2026
Lead Sponsor: AstraZeneca

Full Eligibility Criteria

Inclusion Criteria

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 2 weeks) severe cytopenia due to any cause (eg, ANC< 0.5 × 10^9/L or platelets < 50 × 10^9/L)
Any known predisposition to bleeding (eg, active peptic ulceration, recent [within6 months] hemorrhagic stroke, proliferative diabetic retinopathy.
Spinal cord compression or brain metastases unless asymptomatic and stable.
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.
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.
- -