New drug combo aims to stall advanced prostate cancer
NCT ID NCT07711002
First seen Jul 17, 2026 · Last updated Jul 17, 2026
Summary
This study tests whether adding the experimental drug saruparib to standard hormone therapy can slow the growth of metastatic hormone-sensitive prostate cancer. It includes men whose cancer has not progressed after prior chemotherapy or a specific type of radiation therapy. Participants are randomly assigned to receive either saruparib or a placebo, along with their usual hormone treatment, to see if the combination delays cancer spread and improves survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a drug called saruparib combined with a standard hormone therapy (enzalutamide, darolutamide, or abiraterone)
- What this could lead to
- If successful, this combination could delay cancer progression and extend survival for men with metastatic prostate cancer who have already received initial treatment.
- What could go wrong
- This is an early-stage Phase 3 trial, so results are not yet known. The drug may cause side effects or may not improve outcomes compared to standard therapy alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,330 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2033
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. * \- -
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Research Site
Ottawa, Ontario, K1H 7W9, Canada
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Research Site
Montreal, Quebec, H2X 0A9, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new chemo schedule tame side effects in prostate cancer?
- Precision radiation may boost hormone therapy for advanced prostate cancer
- Targeted radiation plus hormone therapy may slow Low-Volume prostate cancer spread
- New study aims to cut hormone therapy side effects in prostate cancer
- New model predicts prostate cancer treatment response using PET scans