Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07711002

PHASE3

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)

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1330

Start Date

2026-09-15

Completion Date

2033-05-27

Last Updated

2026-10-15

Healthy Volunteers

Conditions

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Interventions

DRUG

Saruparib

Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)

OTHER

Placebo

Arm 2: Placebo + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)

DRUG

Enzalutamide

Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI

DRUG

Darolutamide

Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI

DRUG

Abiraterone

Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI

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. * \- -

Locations (210)

Research Site

Hot Springs, Arkansas, United States

Research Site

Springdale, Arkansas, United States

Research Site

Beverly Hills, California, United States

Research Site

Los Alamitos, California, United States

Research Site

Los Angeles, California, United States

Research Site

San Diego, California, United States

Research Site

Margate, Florida, United States

Research Site

Miami, Florida, United States

Research Site

Orlando, Florida, United States

Research Site

Honolulu, Hawaii, United States

Research Site

Chicago, Illinois, United States

Research Site

Chicago, Illinois, United States

Research Site

Elk Grove Village, Illinois, United States

Research Site

Hinsdale, Illinois, United States

Research Site

Ames, Iowa, United States

Research Site

Baltimore, Maryland, United States

Research Site

Baltimore, Maryland, United States

Research Site

Towson, Maryland, United States

Research Site

Detroit, Michigan, United States

Research Site

Grand Rapids, Michigan, United States

Research Site

Marshall, Minnesota, United States

Research Site

Camden, New Jersey, United States

Research Site

Albuquerque, New Mexico, United States

Research Site

Shirley, New York, United States

Research Site

Canton, Ohio, United States

Research Site

Cincinnati, Ohio, United States

Research Site

Portland, Oregon, United States

Research Site

Portland, Oregon, United States

Research Site

Greenville, South Carolina, United States

Research Site

Aberdeen, South Dakota, United States

Research Site

Mitchell, South Dakota, United States

Research Site

Pierre, South Dakota, United States

Research Site

Sioux Falls, South Dakota, United States

Research Site

Yankton, South Dakota, United States

Research Site

Nashville, Tennessee, United States

Research Site

Austin, Texas, United States

Research Site

Dallas, Texas, United States

Research Site

Fort Worth, Texas, United States

Research Site

Longview, Texas, United States

Research Site

Wichita Falls, Texas, United States

Research Site

Salt Lake City, Utah, United States

Research Site

Spokane, Washington, United States

Research Site

Graz, Austria

Research Site

Linz, Austria

Research Site

Salzburg, Austria

Research Site

Vienna, Austria

Research Site

Barretos, Brazil

Research Site

Brasília, Brazil

Research Site

Natal, Brazil

Research Site

Porto Alegre, Brazil

Research Site

São Caetano do Sul, Brazil

Research Site

São Paulo, Brazil

Research Site

São Paulo, Brazil

Research Site

Calgary, Alberta, Canada

Research Site

Edmonton, Alberta, Canada

Research Site

Abbotsford British Columbia, British Columbia, Canada

Research Site

Brampton, Ontario, Canada

Research Site

Kitchener, Ontario, Canada

Research Site

North York, Ontario, Canada

Research Site

Ottawa, Ontario, Canada

Research Site

Toronto, Ontario, Canada

Research Site

Windsor, Ontario, Canada

Research Site

Greenfield Park, Quebec, Canada

Research Site

Montreal, Quebec, Canada

Research Site

Montreal, Quebec, Canada

Research Site

Saint-Jérôme, Quebec, Canada

Research Site

Saskatoon, Saskatchewan, Canada

Research Site

Beijing, China

Research Site

Changsha, China

Research Site

Chengdu, China

Research Site

Chengdu, China

Research Site

Chongqing, China

Research Site

Fuzhou, China

Research Site

Guangzhou, China

Research Site

Guangzhou, China

Research Site

Guiyang, China

Research Site

Jiaxing, China

Research Site

Jinan, China

Research Site

Kunming, China

Research Site

Kunming, China

Research Site

Lanzhou, China

Research Site

Nanchang, China

Research Site

Nanjing, China

Research Site

Nantong, China

Research Site

Ningbo, China

Research Site

Qingdao, China

Research Site

Shandong, China

Research Site

Shanghai, China

Research Site

Shanghai, China

Research Site

Wenzhou, China

Research Site

Wuhan, China

Research Site

Wuhan, China

Research Site

Wuhan, China

Research Site

Xi'an, China

Research Site

Angers, France

Research Site

Caen, France

Research Site

Montpellier, France

Research Site

Paris, France

Research Site

Poitiers, France

Research Site

Bergisch Gladbach, Germany

And 110 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (210)