NCT07711002Recruiting
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)
Summary
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.
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 \< 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. • \- -
Exclusion criteria
• Hypersensitivity to saruparib, ARPI or any excipients of these products or any contraindication or restriction based on the local label. • 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) • 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. • \- -
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Brazil, Canada, China, Hong Kong, Hungary, India, Japan, Poland, Puerto Rico, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
- Sponsor
- AstraZeneca(Industry)
- Protocol no.
- D972DC00001
- Conditions
- Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Interventions
- Drug, Other
Treatments studied
- Saruparib
- Placebo
- Enzalutamide
- Darolutamide
- Abiraterone
Locations · 6
- Springdale, United StatesResearch SiteRecruiting at this site
- Margate, United StatesResearch SiteRecruiting at this site
- Miami, United StatesResearch SiteRecruiting at this site
- Montreal, CanadaResearch SiteRecruiting at this site
- Daegu, South KoreaResearch SiteRecruiting at this site
- Tainan, TaiwanResearch SiteRecruiting at this site
In total, worldwide, 6 of the 210 sites listed in the registry are recruiting; the other 204 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 15, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
Other identifiers
- 2026-526275-38-00 · CTIS number
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.