RECRUITING

Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

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Conditions

Metastatic Castration-Sensitive Prostate CancerAZD5305; Saruparib; HRRm; non-HRRm; mCSPC; Prostate Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.

Official Title

A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)

Quick Facts

Study Start:2023-11-21
Study Completion:2031-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06120491

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 130 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male ≥ 18 years of age.
  2. * Histologically documented prostate adenocarcinoma which is de novo or recurrent and castration-sensitive. Participants with pathologic features of small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell histology are not eligible.
  3. * Metastatic disease as documented by the investigator prior to randomisation, with clear evidence of ≥ 1 bone lesion and/or ≥ 1 soft tissue lesion that is suitable for repeated assessment with CT and/or MRI.
  4. * Participant is receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy starting ≥ 14 days and \< 4 months prior to randomisation.
  5. * ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomisation.
  6. * Provision of FFPE tumour tissue sample and blood sample (for ctDNA).
  7. * Confirmed HRRm status by central tumour tissue and/or ctDNA test is required to determine cohort eligibility.
  8. * Adequate organ and bone marrow function as described in study protocol.
  9. * Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.
  10. * Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.
  1. * Participants with a history of MDS/AML or with features suggestive of MDS/AML (as determined by prior diagnostic investigation). In case there is no clinical MDS/AML suspicion, no specific screening for MDS/AML (by BM/bone biopsy) is required.
  2. * Participants with any known predisposition to bleeding.
  3. * Any history of persisting (\> 2 weeks) severe cytopenia.
  4. * Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305 and/or the assigned NHA.
  5. * History of another primary malignancy, with exceptions.
  6. * Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy.
  7. * Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
  8. * Cardiac criteria, including history of arrhythmia and cardiovascular disease.
  9. * Any prior anticancer pharmacotherapy or surgery for metastatic prostate cancer, with exceptions.
  10. * Prior treatment within 14 days with blood product support or growth factor support.
  11. * Participants who are unevaluable for both bone and soft tissue progression.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Principal Investigator

Kim Nguyen Chi, MD
PRINCIPAL_INVESTIGATOR
BC Cancer, Canada
Arun Azad, MD
PRINCIPAL_INVESTIGATOR
Peter MacCallum Cancer Centre, Australia

Study Locations (Sites)

Research Site
Chandler, Arizona, 85224
United States
Research Site
Gilbert, Arizona, 85234
United States
Research Site
Phoenix, Arizona, 85054
United States
Research Site
Tucson, Arizona, 85741
United States
Research Site
Little Rock, Arkansas, 72205
United States
Research Site
Springdale, Arkansas, 72762
United States
Research Site
Bakersfield, California, 93301
United States
Research Site
Fountain Valley, California, 92708
United States
Research Site
Fullerton, California, 92835
United States
Research Site
Los Angeles, California, 90073
United States
Research Site
Los Angeles, California, 90095
United States
Research Site
Montebello, California, 90640
United States
Research Site
Pasadena, California, 91101
United States
Research Site
Pomona, California, 91767
United States
Research Site
Sacramento, California, 95816
United States
Research Site
San Diego, California, 92123
United States
Research Site
San Francisco, California, 94115
United States
Research Site
Santa Barbara, California, 93105
United States
Research Site
Santa Monica, California, 90404
United States
Research Site
Santa Rosa, California, 95403
United States
Research Site
Golden, Colorado, 80401
United States
Research Site
Lakewood, Colorado, 80228
United States
Research Site
New Haven, Connecticut, 06510
United States
Research Site
Norwich, Connecticut, 06360
United States
Research Site
Newark, Delaware, 19713
United States
Research Site
Jacksonville, Florida, 32209
United States
Research Site
Jacksonville, Florida, 32224
United States
Research Site
Palm Bay, Florida, 32909
United States
Research Site
Saint Petersburg, Florida, 33705
United States
Research Site
Tampa, Florida, 33612
United States
Research Site
Atlanta, Georgia, 30318
United States
Research Site
Glenview, Illinois, 60026
United States
Research Site
Lake Barrington, Illinois, 60010
United States
Research Site
Fort Wayne, Indiana, 46804
United States
Research Site
Indianapolis, Indiana, 46202
United States
Research Site
Des Moines, Iowa, 50309
United States
Research Site
Westwood, Kansas, 66205
United States
Research Site
Wichita, Kansas, 67226
United States
Research Site
Lexington, Kentucky, 40503
United States
Research Site
Louisville, Kentucky, 40202
United States
Research Site
Shreveport, Louisiana, 71103
United States
Research Site
Scarborough, Maine, 04074
United States
Research Site
Baltimore, Maryland, 21201
United States
Research Site
Baltimore, Maryland, 21287
United States
Research Site
Bethesda, Maryland, 20817
United States
Research Site
Towson, Maryland, 21204
United States
Research Site
Upper Marlboro, Maryland, 20774
United States
Research Site
Grand Rapids, Michigan, 49503
United States
Research Site
Troy, Michigan, 48084
United States
Research Site
Rochester, Minnesota, 55905
United States
Research Site
Columbia, Missouri, 65212
United States
Research Site
Billings, Montana, 59102
United States
Research Site
Bozeman, Montana, 59715
United States
Research Site
Las Vegas, Nevada, 89102
United States
Research Site
Las Vegas, Nevada, 89148
United States
Research Site
Belleville, New Jersey, 07109
United States
Research Site
Brick, New Jersey, 08724
United States
Research Site
Camden, New Jersey, 08103
United States
Research Site
East Brunswick, New Jersey, 08816
United States
Research Site
Voorhees, New Jersey, 08043
United States
Research Site
Albuquerque, New Mexico, 87109
United States
Research Site
Albuquerque, New Mexico, 87110
United States
Research Site
Rio Rancho, New Mexico, 87124
United States
Research Site
Albany, New York, 12206
United States
Research Site
Bronx, New York, 10469
United States
Research Site
New Hyde Park, New York, 11042
United States
Research Site
New York, New York, 10028
United States
Research Site
New York, New York, 10029
United States
Research Site
Shirley, New York, 11967
United States
Research Site
Syracuse, New York, 13210
United States
Research Site
Durham, North Carolina, 27710
United States
Research Site
Fayetteville, North Carolina, 28303
United States
Research Site
Cincinnati, Ohio, 45212
United States
Research Site
Cincinnati, Ohio, 45219
United States
Research Site
Cleveland, Ohio, 44109
United States
Research Site
Cleveland, Ohio, 44111
United States
Research Site
Cleveland, Ohio, 44124
United States
Research Site
Cleveland, Ohio, 44130
United States
Research Site
Columbus, Ohio, 43201
United States
Research Site
Independence, Ohio, 44131
United States
Research Site
Wooster, Ohio, 44691
United States
Research Site
Florence, Oregon, 97439
United States
Research Site
Portland, Oregon, 97227
United States
Research Site
Portland, Oregon, 97239
United States
Research Site
Bala-Cynwyd, Pennsylvania, 19004-1017
United States
Research Site
Philadelphia, Pennsylvania, 19104
United States
Research Site
Pittsburgh, Pennsylvania, 15212
United States
Research Site
Pittsburgh, Pennsylvania, 15213
United States
Research Site
York, Pennsylvania, 17403
United States
Research Site
Providence, Rhode Island, 02903
United States
Research Site
Myrtle Beach, South Carolina, 29572
United States
Research Site
North Charleston, South Carolina, 29406
United States
Research Site
Sioux Falls, South Dakota, 57105
United States
Research Site
Germantown, Tennessee, 38138
United States
Research Site
Nashville, Tennessee, 37203
United States
Research Site
Dallas, Texas, 75231
United States
Research Site
Dallas, Texas, 75246
United States
Research Site
Denton, Texas, 76201
United States
Research Site
Flower Mound, Texas, 75028
United States
Research Site
Grapevine, Texas, 76051
United States
Research Site
Houston, Texas, 77025
United States
Research Site
Houston, Texas, 77027
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Plano, Texas, 75093
United States
Research Site
San Antonio, Texas, 78217
United States
Research Site
San Antonio, Texas, 78229
United States
Research Site
Sugar Land, Texas, 77479
United States
Research Site
Tyler, Texas, 75702
United States
Research Site
Wichita Falls, Texas, 76310
United States
Research Site
Saint George, Utah, 84790
United States
Research Site
Salt Lake City, Utah, 84106
United States
Research Site
Salt Lake City, Utah, 84132
United States
Research Site
Fairfax, Virginia, 22031
United States
Research Site
Winchester, Virginia, 22601
United States
Research Site
Spokane Valley, Washington, 99216
United States
Research Site
Spokane, Washington, 99202
United States
Research Site
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: AstraZeneca

  • Kim Nguyen Chi, MD, PRINCIPAL_INVESTIGATOR, BC Cancer, Canada
  • Arun Azad, MD, PRINCIPAL_INVESTIGATOR, Peter MacCallum Cancer Centre, Australia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-21
Study Completion Date2031-04-30

Study Record Updates

Study Start Date2023-11-21
Study Completion Date2031-04-30

Terms related to this study

Keywords Provided by Researchers

  • AZD5305; Saruparib; HRRm; non-HRRm; mCSPC; Prostate Cancer

Additional Relevant MeSH Terms

  • Metastatic Castration-Sensitive Prostate Cancer