Saruparib plus physician’s ARPI choice vs placebo in men with metastatic hormone-sensitive prostate cancer previously treated with docetaxel or Lu-PSMA

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3 interventional trial evaluating the effect of saruparib in combination with a physician’s choice of an androgen receptor pathway inhibitor (ARPI) versus placebo with ARPI in men with metastatic hormone-sensitive prostate cancer who have previously received docetaxel chemotherapy or Lu-PSMA therapy and have no disease progression. Eligible participants must have PSA ≥ 0.2 ng/mL and be on androgen deprivation therapy with castration-level testosterone, among other criteria. The study lists saruparib, placebo, enzalutamide, darolutamide, and abiraterone as interventions, with primary objective focused on efficacy. Primary outcomes likely include progression-free or overall survival, with safety monitoring per standard oncology trial practices.

Why it matters

Who can join: the full rules

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.
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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.
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Where it's running

• Research Site
  Springdale, Arkansas, United States Recruiting
• Research Site
  Margate, Florida, United States Recruiting
• Research Site
  Miami, Florida, United States Recruiting
• Research Site
  Montreal, Quebec, Canada Recruiting
• Research Site
  Daegu, South Korea Recruiting
• Research Site
  Tainan, Taiwan Recruiting

+160 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.