A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
Recruiting · NCT07225946 · Interventional (participants receive a specific treatment) · Lead sponsor: Janssen Research & Development, LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The purpose of this study is to find out whether treatment with pasritamig and docetaxel prolongs radiographic progression free survival (rPFS) (the length of time from start of treatment until disease worsens as determined by scans or death due to any cause) when compared to treatment with docetaxel in participants with metastatic castrate-resistant prostate cancer (mCRPC; a cancer of prostate, a male reproductive gland found below the bladder, that grows despite low levels of male hormones).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Have histologically confirmed adenocarcinoma of the prostate
- Have disease that is metastatic at the time of screening by computed tomography (CT) or magnetic resonance imaging (MRI) and 99m\^Tc bone scan as determined by the investigator
- Participants must receive ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analog throughout the treatment or have had prior bilateral orchiectomy, and have serum testosterone less than or equal to (\<=) 50 nanogram per deciliter (ng/dL) (\<= 1.73 nanomoles per Liter \[nmol/L\]) at screening
- Have progressed by PSA or CT/MRI or 99m\^Tc bone scan on at least 1 novel androgen receptor pathway inhibition (ARPI) but no more than 2 different ARPI for any stage of disease. Must have discontinued ARPI before randomization into the study
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
Exclusion criteria
- Known history of either brain or leptomeningeal prostate cancer metastases
- Participants with known breast cancer gene 1/2 (BRCA 1/2) mutations (germline or somatic) who have not received treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor, unless not available or contraindicated
- Prior or concurrent second malignancy (other than the disease under study)
- Received cytotoxic chemotherapy for prostate cancer in any setting
- Received prior treatment with human kallikrein 2 (KLK-2) directed therapies
Where it is running
60 locations listed across 27 US states.
- Arizona Clinical Trials - Chandler, Arizona, United States
- Arkansas Urology - Little Rock, Arkansas, United States
- MemorialCare Orange Coast Medical Center - Fountain Valley, California, United States
- University Of California San Diego - La Jolla, California, United States
- Cancer and Blood Specialty Clinic - Los Alamitos, California, United States
- USC Norris Comprehensive Cancer Center - Los Angeles, California, United States
- Valkyrie Clinical Trials - Los Angeles, California, United States
- Kaiser Permanente Southern California - Riverside, California, United States
- Sharp Center for Research - San Diego, California, United States
- Providence Saint John s Health Center - Santa Monica, California, United States
- Rocky Mountain Cancer Centers - Aurora, Colorado, United States
- Vail Health Shaw Cancer Center - Edwards, Colorado, United States
- Grand Valley Oncology - Grand Junction, Colorado, United States
- Colorado Clinical Research - Lakewood, Colorado, United States
- AdventHealth Orlando - Orlando, Florida, United States
- Florida Cancer Specialists - Sarasota, Florida, United States
- Winship Cancer Institute Emory University - Atlanta, Georgia, United States
- Duly Health and Care - Lisle, Illinois, United States
- Cancer Center of Kansas Heritage Plaza Medical Building - Wichita, Kansas, United States
- St Elizabeth Healthcare - Edgewood, Kentucky, United States
- Norton Cancer Institute - Louisville, Kentucky, United States
- East Jefferson General Hospital - Metairie, Louisiana, United States
- University of Maryland - Baltimore, Maryland, United States
- Johns Hopkins Hospital - Baltimore, Maryland, United States
- Johns Hopkins Medical Institutions - Baltimore, Maryland, United States
- Chesapeake Urology Research Associates - Towson, Maryland, United States
- Profound Research LLC at Cancer and Leukemia Center - Sterling Heights, Michigan, United States
- HealthPartners Frauenshuh Cancer Center CRC West - Saint Louis Park, Minnesota, United States
- HealthPartners Cancer Center at Regions Hospital CRC East - Saint Paul, Minnesota, United States
- University of Mississippi Medical Center - Jackson, Mississippi, United States
- Washington University - St Louis, Missouri, United States
- NHO Revive Research Institute, LLC - Lincoln, Nebraska, United States
- Astera Cancer Care - East Brunswick, New Jersey, United States
- Rutgers Cancer Institute of New Jersey - New Brunswick, New Jersey, United States
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island - Mineola, New York, United States
- NYU Langone Health Laura and Isaac Perlmutter Cancer Center - New York, New York, United States
- Montefiore Medical Center - The Bronx, New York, United States
- University of Cincinnati - Cincinnati, Ohio, United States
- Oregon Urology Institute - Springfield, Oregon, United States
- Lehigh Valley Hospital - Allentown, Pennsylvania, United States
- MidLantic Urology - Bala-Cynwyd, Pennsylvania, United States
- Penn State Milton S. Hershey Medical Center - Hershey, Pennsylvania, United States
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center - Pittsburgh, Pennsylvania, United States
- Carolina Urologic Research Center - Myrtle Beach, South Carolina, United States
- Avera Medical Group - Sioux Falls, South Dakota, United States
- Tennessee Cancer Specialists - Knoxville, Tennessee, United States
- Texas Oncology - Austin, Texas, United States
- UT Southwestern Medical Center - Dallas, Texas, United States
- Houston Metro Urology - Houston, Texas, United States
- Texas Oncology 1 - Sugar Land, Texas, United States
- Virginia Cancer Specialists - Fairfax, Virginia, United States
- Fred Hutch Cancer Center Sloan Clinic 2 - Seattle, Washington, United States
- Fred Hutchinson Cancer Research Center - Seattle, Washington, United States
- AZORG campus Aalst Moorselbaan - Aalst, Belgium
- Adana City Hospital - Adana, Turkey (Türkiye)
- Gulhane Training and Research Hospital - Ankara, Turkey (Türkiye)
- Ankara University Medical Faculty - Ankara, Turkey (Türkiye)
- ZAS Augustinus - Antwerp, Belgium
- Hosp. Univ. Germans Trias I Pujol - Badalona, Spain
- NAIC Nair Antunes Instituto do Cancer - Bauru, Brazil
Showing 60 of 152 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →