Clinical trial for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Official title 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)
ClinicalTrials.gov ID: NCT07711002
What this study is testing
What is Saruparib?
An investigational oral medication being studied for metastatic hormone‑sensitive prostate cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study compares the effectiveness of saruparib plus an ARPI drug with a placebo plus the same ARPI drug in men with metastatic hormone‑sensitive prostate cancer who have not shown disease progression after prior docetaxel or 177Lu‑PSMA therapy.
- Who it's for
- Men with metastatic hormone‑sensitive prostate cancer who have previously received docetaxel chemotherapy or 177Lu‑PSMA therapy and have a PSA level of at least 0.2 ng/mL.
- What's involved
- Participants will receive either saruparib or a placebo along with a chosen ARPI drug, and will attend regular clinic visits for treatment and monitoring.
- Time commitment
- The study lasts for several months, with scheduled visits for medication administration and health assessments.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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.
- Must be receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy.
You likely can't join if
- 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.
See the full eligibility 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.
- 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...
- 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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- 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...
- Any prior treatment with a PARPi or platinum chemotherapy.
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The study team makes the final eligibility decision.
Where it is enrolling
- Springdale, Arkansas, United States
- Margate, Florida, United States
- Miami, Florida, United States
- Montreal, Quebec, Canada
- Daegu, South Korea
- Tainan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Springdale, Arkansas, United States; Margate, Florida, United States; Miami, Florida, United States; Montreal, Quebec, Canada; Daegu, South Korea; Tainan, Taiwan. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.