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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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 \< 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. * \- -
Study sites (42)
AR
- Research Site · Hot Springs, AR 71913More trials in Hot Springs
- Research Site · Springdale, AR 72762More trials in Springdale
CA
- Research Site · Beverly Hills, CA 90211More trials in Beverly Hills
- Research Site · Los Alamitos, CA 90720More trials in Los Alamitos
- Research Site · Los Angeles, CA 90089More trials in Los Angeles
- Research Site · San Diego, CA 92123More trials in San Diego
FL
- Research Site · Margate, FL 33063More trials in Margate
- Research Site · Miami, FL 33165More trials in Miami
- Research Site · Orlando, FL 32806More trials in Orlando
HI
- Research Site · Honolulu, HI 96813More trials in Honolulu
IA
- Research Site · Ames, IA 50010More trials in Ames
IL
- Research Site · Chicago, IL 60637More trials in Chicago
- Research Site · Chicago, IL 60657More trials in Chicago
- Research Site · Elk Grove Village, IL 60007More trials in Elk Grove Village
- Research Site · Hinsdale, IL 60521More trials in Hinsdale
MD
- Research Site · Baltimore, MD 21201More trials in Baltimore
- Research Site · Baltimore, MD 21229More trials in Baltimore
- Research Site · Towson, MD 21204More trials in Towson
MI
- Research Site · Detroit, MI 48202More trials in Detroit
- Research Site · Grand Rapids, MI 49503More trials in Grand Rapids
MN
- Research Site · Marshall, MN 56258More trials in Marshall
NJ
- Research Site · Camden, NJ 08103More trials in Camden
NM
- Research Site · Albuquerque, NM 87109More trials in Albuquerque
NY
- Research Site · Shirley, NY 11967More trials in Shirley
OH
- Research Site · Canton, OH 44718More trials in Canton
- Research Site · Cincinnati, OH 45267More trials in Cincinnati
OR
- Research Site · Portland, OR 97213More trials in Portland
- Research Site · Portland, OR 97227More trials in Portland
SC
- Research Site · Greenville, SC 29607More trials in Greenville
SD
- Research Site · Aberdeen, SD 57401More trials in Aberdeen
- Research Site · Mitchell, SD 57301More trials in Mitchell
- Research Site · Pierre, SD 57501More trials in Pierre
- Research Site · Sioux Falls, SD 57105More trials in Sioux Falls
- Research Site · Yankton, SD 57078More trials in Yankton
TN
- Research Site · Nashville, TN 37203More trials in Nashville
TX
- Research Site · Austin, TX 78745More trials in Austin
- Research Site · Dallas, TX 75235More trials in Dallas
- Research Site · Fort Worth, TX 76104More trials in Fort Worth
- Research Site · Longview, TX 75605More trials in Longview
- Research Site · Wichita Falls, TX 76310More trials in Wichita Falls
UT
- Research Site · Salt Lake City, UT 84112More trials in Salt Lake City
WA
- Research Site · Spokane, WA 99202More trials in Spokane