AzTrials
AzTrials

Castration-Resistant Prostate CarcinomaPhase 3NCT06470243

Testing Whether the Addition of Carboplatin Chemotherapy to Cabazitaxel Chemotherapy Will Improve Outcomes Compared to Cabazitaxel Alone in People With Castrate-Resistant Prostate Cancer That Has Spread Beyond the Prostate to Other Parts of the Body

A Phase 3 study testing Biospecimen Collection, Bone Scan and Cabazitaxel in people with Castration-Resistant Prostate Carcinoma and Stage IVB Prostate Cancer AJCC v8, run by SWOG Cancer Research Network at 174 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase III trial compares the effect of adding carboplatin to the standard of care chemotherapy drug cabazitaxel versus cabazitaxel alone in treating prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castrate-resistant) and that has spread from where… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Biospecimen Collection, Bone Scan and Cabazitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
528 participants
Where
174 sitesUnited States
Study dates
27 Nov 2024to Apr 2034
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • STEP 1 SCREENING REGISTRATION: NOTE: All participants must have biopsy tissue submitted to MD Anderson Cancer Center prior to randomization for alteration assessment. Participants must have determination of their AVPC-Molecular Pathologic Signature immunohistochemistry (MSIHC) status from central assessment by the MD Anderson Clinical Pathology Laboratory using Clinical Laboratory Improvement Act (CLIA) certified immunohistochemistry (IHC) assays for TP53, RB1 and PTEN. In addition, while not mandated, CLIA certified next generation sequencing (NGS) of tumor deoxyribonucleic acid (DNA) and/or circulating tumor derived DNA (ctDNA) assessment of AVPC-MS marker status will be collected from participants for whom it is available
  • STEP 1 SCREENING REGISTRATION: Participants must have a histologically confirmed diagnosis of prostate cancer at the time of step 1 registration
  • STEP 1 SCREENING REGISTRATION: Participants must have castrate-resistant prostate cancer and metastatic disease by bone scan and/or CT/MRI (i.e., soft tissue, visceral, lymph node)
  • STEP 1 SCREENING REGISTRATION: Participants may have received any prior therapy, but one must be docetaxel or contain docetaxel in either the castrate-sensitive and/or castrate resistant disease state
  • STEP 1 SCREENING REGISTRATION: Participants must be ≥ 18 years of age at the time of step 1 screening registration
  • STEP 1 SCREENING REGISTRATION: Participants must have solid tumor biopsy material (formalin-fixed paraffin-embedded (FFPE) tissue blocks and/or 10 cut slides on four-micron thick unstained positive charged slides of FFPE tissue) available for submission for alterations in TP53, RB1 and PTEN by IHC using CLIA certified assays in the MD Anderson Clinical Pathology Laboratory. This specimen is required for central assessment of the AVPC-MSIHC regardless of whether the site has already locally evaluated the AVPC-MS status
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  • STEP 1 SCREENING REGISTRATION: Tumor samples submitted for analysis must have been collected within 12 months prior to step 1 screening registration. Samples from metastatic lesions collected in the castrate-resistant disease state are preferable but not mandatory. Samples obtained during the hormone-naive disease state are acceptable if collected within 12 months of step 1 screening registration. If more than one tumor sample exists, the sample obtained closest to the date of registration should be submitted to MDACC for analysis
  • NOTE: Sites will receive an email from Southwest Oncology Group (SWOG) Statistics and Data Management Center containing participant results of Aggressive Variant Prostate Cancer Molecular Signature (AVPC-MS) assessment within 5-12 business days after tissue submission to MD Anderson Clinical Pathology Laboratory. The participant's AVPC-MS signature result (positive or negative) is required BEFORE randomization on to step 2. If sites receive a non-evaluable AVPC-MS signature result, SWOG Statistics and Data Management Center will provide instructions for resubmission
  • STEP 1 SCREENING REGISTRATION: NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • STEP 1 SCREENING REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. Documentation of informed consent via remote consent is allowed
  • For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
  • STEP 2 RANDOMIZATION: NOTE: Participants must be registered to step 2 randomization within 70 days after registration to step 1. Participants must plan to start protocol therapy no more than 14 days after step 2 randomization
  • STEP 2 RANDOMIZATION: Participants must have castrate levels of testosterone with a baseline level < 50ng/dL within 28 days prior to step 2 randomization
  • STEP 2 RANDOMIZATION: Participants must have evidence for metastatic prostate cancer by bone scan and/or CT/MRI (i.e., soft tissue, visceral, lymph node). Visceral and/or soft-tissue metastases must be ≥ 1.0 cm in diameter and lymph nodes must be > 1.5 cm diameter in the short axis. Scans must be obtained within 28 days prior to randomization
  • NOTE: All disease must be assessed and documented on the baseline/pre-registration tumor assessment form
  • STEP 2 RANDOMZIATION: Participants must have progressive disease (PD) in the opinion of the treating investigator according to any of the following criteria
  • Progression in measurable disease (RECIST 1.1 criteria). Patient with measurable disease must have at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be at least 10 mm when measured by computed tomography (CT) [CT scan thickness no greater than 5 mm] or magnetic resonance imaging (MRI). Lymph nodes should be ≥ 15 mm in short axis. Previously irradiated lesions, primary prostate lesion and bone lesions will be considered non-measurable disease
  • Progression in bone as evidenced by:
  • Appearance of 2 or more new bone lesions on bone scan (BS). If equivocal, they must be confirmed by other imaging modalities (CT; MRI), and/or repeat BS > 4 weeks later
  • Appearance of a new lytic lesion(s) and/or increasing size of an existing lesion by CT/MRI, since AVPC tumors may produce lytic bone lesions that are not detected on conventional bone scans
  • Rising prostate-specific antigen (PSA) defined (Prostate Cancer Working Group 2 [PCWG2]) as at least two consecutive rises in PSA to be documented over a reference value (measure 1) taken at least one week apart. The first rising PSA (measure 2) should be taken at least 7 days after the reference value. A third confirmatory PSA measure is required (2nd beyond the reference level) to be greater than the second measure and it must be obtained at least 7 days after the 2nd measure. If this is not the case, a fourth PSA measure is required to be taken and be greater than the 2nd measure. In case of progression based on rising PSA only, the first rising PSA (measure 2) must be obtained within 6 months of initiation of androgen receptor (AR) targeted therapy (≤ 6 months)
  • Clinical progression. Increasing symptoms unequivocally attributed to disease progression as judged by the treating physician
  • STEP 2 RANDOMIZATION: Participants must not have received prior cabazitaxel or carboplatin
  • STEP 2 RANDOMIZATION: Participants must not be receiving treatment on another therapeutic clinical trial at the time of randomization. Chemotherapies, bone targeting therapies, immunotherapies and clinical trial agents must be discontinued ≥ 21 days prior to randomization. Stereotactic radiation (SART) must be discontinued ≥ 3 days prior to randomization
  • STEP 2 RANDOMIZATION: Participants must not be receiving radiation therapy or kyphoplasty-vertebroplasty within 14 days prior to randomization or major surgery (e.g., open abdominal, pelvic, thoracic, orthopedic or neurosurgery) within 28 days prior to step 2 randomization
  • STEP 2 RANDOMIZATION: Participants must not have untreated fractures and/or cord compression
  • STEP 2 RANDOMIZATION: Participants must not have symptomatic uncontrolled brain metastases. Properly treated brain metastases (i.e., with stereotactic radiation) within 14 days are allowed
  • STEP 2 RANDOMIZATION: Participants must have Zubrod performance status of 0 - 2 within 28 days prior to step 2 randomization
  • STEP 2 RANDOMIZATION: Participants must have a complete medical history and physical exam within 28 days prior to step 2 randomization
  • STEP 2 RANDOMIZATION: Absolute neutrophil count ≥ 1.5 x 10^3/uL (within 28 days prior to step 2 randomization)
  • STEP 2 RANDOMIZATION: Platelets ≥ 100 x 10^3/uL (unless clinical evidence of bone marrow infiltration by tumor in which case > 75 x 10^3/uL are allowed) (within 28 days prior to step 2 randomization)
  • STEP 2 RANDOMIZATION: Total bilirubin ≤ institutional upper limit of normal (ULN) with the exception of isolated hyperbilirubinemia due to Gilbert's syndrome or if the participant has liver metastases and/or acute tumor associated illness < 4x ULN (within 28 days prior to step 2 randomization)
  • STEP 2 RANDOMIZATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN (or if participant has liver metastases and/or acute tumor-associated illness, ≤ 4x institutional ULN) (within 28 days prior to step 2 randomization)
  • STEP 2 REGISTRATION: Participants must have a calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to step 2 randomization
  • STEP 2 RANDOMIZATION: Participants with peripheral neuropathy must have ≤ grade 2 peripheral neuropathy (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) (within 28 days prior to step 2 randomization)
  • STEP 2 RANDOMIZATION: Participants who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including vasectomy with testing showing no sperm in the semen
  • STEP 2 RANDOMIZATION: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the treatment regimen
  • STEP 2 RANDOMIZATION: Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration
  • STEP 2 RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System

Who cannot join

None listed.

Trial locations and contacts

174 sites in 1 country. Contact the study team or a site near you to ask about taking part.

174 sites in 1 country

United States174 sites, 174 recruiting

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Elie G. Dib

    Recruiting

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Saint Alphonsus Cancer Care Center-Baker City

    Baker City, Oregon, 97814

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

    Site Public Contact, 402-559-6941, unmcrsa@unmc.edu

    Benjamin A. Teply

    Recruiting

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Elie G. Dib

    Recruiting

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Saint Elizabeth Boardman Hospital

    Boardman, Ohio, 44512

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    John M. Schallenkamp

    Recruiting

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    John M. Schallenkamp

    Recruiting

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 573-334-2230, sfmc@sfmc.net

    Bryan A. Faller

    Recruiting

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 573-651-5550

    Bryan A. Faller

    Recruiting

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

    Site Public Contact, 618-457-5200, clinical.research@sih.net

    Bryan A. Faller

    Recruiting

  • Caro Cancer Center

    Caro, Michigan, 48723

    Site Public Contact, 989-907-8411, lori.srebinski@ascension.org

    Elie G. Dib

    Recruiting

  • SIH Cancer Institute

    Carterville, Illinois, 62918

    Site Public Contact, 618-985-3333, clinical.research@sih.net

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

    Site Public Contact, 319-365-4673

    Deborah W. Wilbur

    Recruiting

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

    Site Public Contact, 319-363-2690

    Deborah W. Wilbur

    Recruiting

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    Maha H. Hussain

    Recruiting

  • University of Illinois

    Chicago, Illinois, 60612

    Site Public Contact, 312-355-3046

    Natalie Reizine

    Recruiting

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • MD Anderson in The Woodlands

    Conroe, Texas, 77384

    Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org

    Paul Corn

    Recruiting

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Maha H. Hussain

    Recruiting

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

    Site Public Contact, 313-343-3166, Kkeenan1@hfhs.org

    Elie G. Dib

    Recruiting

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

    Site Public Contact, 815-285-7800

    Bryan A. Faller

    Recruiting

  • Great Lakes Cancer Management Specialists-Doctors Park

    East China Township, Michigan, 48054

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Elie G. Dib

    Recruiting

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Elie G. Dib

    Recruiting

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Christiana Care - Union Hospital

    Elkton, Maryland, 21921

    Site Public Contact, 410-443-1360, frank.crum@christianacare.org

    Gregory A. Masters

    Recruiting

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Highlands Oncology Group - Fayetteville

    Fayetteville, Arkansas, 72703

    Site Public Contact, 479-872-8100, research@hogonc.com

    Joseph T. Beck

    Recruiting

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Orion Cancer Care

    Findlay, Ohio, 45840

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Genesee Cancer and Blood Disease Treatment Center

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Elie G. Dib

    Recruiting

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Elie G. Dib

    Recruiting

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Elie G. Dib

    Recruiting

  • Hurley Medical Center

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Elie G. Dib

    Recruiting

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

    Site Public Contact, eileen.georgi@holy-cross.com

    Elie G. Dib

    Recruiting

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

    Site Public Contact, 309-344-2831

    Bryan A. Faller

    Recruiting

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Maha H. Hussain

    Recruiting

  • The West Clinic - Wolf River

    Germantown, Tennessee, 38138

    Site Public Contact, 901-683-0055, afletcher@westclinic.com

    Bradley G. Somer

    Recruiting

  • Northwestern Medicine Glenview Outpatient Center

    Glenview, Illinois, 60026

    Site Public Contact, 312-695-1102

    Maha H. Hussain

    Recruiting

  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, 60030

    Site Public Contact, 312-695-1102

    Maha H. Hussain

    Recruiting

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Great Falls Clinic

    Great Falls, Montana, 59405

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Dayton Physicians LLC-Wayne

    Greenville, Ohio, 45331

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Wayne Hospital

    Greenville, Ohio, 45331

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

    Grosse Pointe Woods, Michigan, 48236

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Elie G. Dib

    Recruiting

  • Henry Ford Saint John Hospital - Academic

    Grosse Pointe Woods, Michigan, 48236

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Elie G. Dib

    Recruiting

  • Henry Ford Saint John Hospital - Breast

    Grosse Pointe Woods, Michigan, 48236

    Site Public Contact, 313-343-3166, karen.forman@ascension.org

    Elie G. Dib

    Recruiting

  • Lehigh Valley Hospital-Hazleton

    Hazleton, Pennsylvania, 18201

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Elie G. Dib

    Recruiting

  • Lyndon Baines Johnson General Hospital

    Houston, Texas, 77026-1967

    Site Public Contact, 713-566-5000

    Paul Corn

    Recruiting

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org

    Paul Corn

    Recruiting

  • MD Anderson West Houston

    Houston, Texas, 77079

    Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org

    Paul Corn

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Site Public Contact, 601-815-6700

    John C. Henegan

    Recruiting

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Kettering Medical Center

    Kettering, Ohio, 45429

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

    Site Public Contact, cancertrials@northwestern.edu

    Maha H. Hussain

    Recruiting

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

    Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org

    Elie G. Dib

    Recruiting

  • MD Anderson League City

    League City, Texas, 77573

    Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org

    Paul Corn

    Recruiting

  • Beebe Medical Center

    Lewes, Delaware, 19958

    Site Public Contact, 302-291-6730, research@beebehealthcare.org

    Gregory A. Masters

    Recruiting

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Tibor Rubin VA Medical Center

    Long Beach, California, 90822

    Site Public Contact, 562-826-8000

    Pankaj Gupta

    Recruiting

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Great Lakes Cancer Management Specialists-Macomb Medical Campus

    Macomb, Michigan, 48044

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Elie G. Dib

    Recruiting

  • Henry Ford Warren Hospital - Breast Macomb

    Macomb, Michigan, 48044

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Elie G. Dib

    Recruiting

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Saint Mary's Oncology/Hematology Associates of Marlette

    Marlette, Michigan, 48453

    Site Public Contact, 989-907-8411, lori.srebinski@ascension.org

    Elie G. Dib

    Recruiting

  • Idaho Urologic Institute-Meridian

    Meridian, Idaho, 83642

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    John M. Schallenkamp

    Recruiting

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

    Site Public Contact, 302-291-6730, research@beebehealthcare.org

    Gregory A. Masters

    Recruiting

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Community Medical Center

    Missoula, Montana, 59804

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • HSHS Saint Elizabeth's Hospital

    O'Fallon, Illinois, 62269

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Adanma Anji Ayanambakkam Attanathi

    Recruiting

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118

    Site Public Contact, 402-559-5600

    Benjamin A. Teply

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Site Public Contact, 402-559-6941, unmcrsa@unmc.edu

    Benjamin A. Teply

    Recruiting

  • Saint Alphonsus Cancer Care Center-Ontario

    Ontario, Oregon, 97914

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462

    Site Public Contact, nctnprogram_rhlccc@northwestern.edu

    Maha H. Hussain

    Recruiting

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Valley Radiation Oncology

    Peru, Illinois, 61354

    Site Public Contact, 815-664-4141

    Bryan A. Faller

    Recruiting

  • Hope Cancer Center

    Pontiac, Michigan, 48341

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Michigan Healthcare Professionals Pontiac

    Pontiac, Michigan, 48341

    Site Public Contact, 248-858-6215, Emily.Crofts@trinity-health.org

    Elie G. Dib

    Recruiting

  • Newland Medical Associates-Pontiac

    Pontiac, Michigan, 48341

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Fairview Northland Medical Center

    Princeton, Minnesota, 55371

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

    Site Public Contact, 302-291-6730, research@beebehealthcare.org

    Gregory A. Masters

    Recruiting

  • Reid Health

    Richmond, Indiana, 47374

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235

    Site Public Contact, ctoclinops@vcu.edu

    John Melson

    Recruiting

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

    Site Public Contact, CTOclinops@vcu.edu

    John Melson

    Recruiting

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Highlands Oncology Group - Rogers

    Rogers, Arkansas, 72758

    Site Public Contact, 479-872-8130, research@hogonc.com

    Joseph T. Beck

    Recruiting

  • MyMichigan Medical Center Saginaw

    Saginaw, Michigan, 48601

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Oncology Hematology Associates of Saginaw Valley PC

    Saginaw, Michigan, 48604

    Site Public Contact, 989-907-8411, lori.srebinski@ascension.org

    Elie G. Dib

    Recruiting

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Regions Hospital

    Saint Paul, Minnesota, 55101

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • United Hospital

    Saint Paul, Minnesota, 55102

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Kootenai Clinic Cancer Services - Sandpoint

    Sandpoint, Idaho, 83864

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

    Site Public Contact, 479-872-8130, research@hogonc.com

    Joseph T. Beck

    Recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

    Site Public Contact, 217-545-7929

    Bryan A. Faller

    Recruiting

  • Springfield Clinic

    Springfield, Illinois, 62702

    Site Public Contact, 800-444-7541

    Bryan A. Faller

    Recruiting

  • Memorial Medical Center

    Springfield, Illinois, 62781

    Site Public Contact, 217-528-7541, pallante.beth@mhsil.com

    Bryan A. Faller

    Recruiting

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • MD Anderson in Sugar Land

    Sugar Land, Texas, 77478

    Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org

    Paul Corn

    Recruiting

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • BJC Outpatient Center at Sunset Hills

    Sunset Hills, Missouri, 63127

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • MyMichigan Medical Center Tawas

    Tawas City, Michigan, 48764

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Dayton Physicians LLC - Troy

    Troy, Ohio, 45373

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Great Lakes Cancer Management Specialists-Macomb Professional Building

    Warren, Michigan, 48093

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Elie G. Dib

    Recruiting

  • Henry Ford Madison Heights Hospital - Breast

    Warren, Michigan, 48093

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Elie G. Dib

    Recruiting

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Elie G. Dib

    Recruiting

  • Saint Joseph Warren Hospital

    Warren, Ohio, 44484

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Maha H. Hussain

    Recruiting

  • Illinois CancerCare - Washington

    Washington, Illinois, 61571

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Saint Mary's Oncology/Hematology Associates of West Branch

    West Branch, Michigan, 48661

    Site Public Contact, 989-907-8411, lori.srebinski@ascension.org

    Elie G. Dib

    Recruiting

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Christiana Care Health System-Wilmington Hospital

    Wilmington, Delaware, 19801

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Fairview Lakes Medical Center

    Wyoming, Minnesota, 55092

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Saint Elizabeth Youngstown Hospital

    Youngstown, Ohio, 44501

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Huron Gastroenterology PC

    Ypsilanti, Michigan, 48106

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    Ypsilanti, Michigan, 48197

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Elie G. Dib

    Recruiting

Other trials in United States

About this study

Official title: A Phase III Study of Cabazitaxel With or Without Carboplatin in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC), Stratified by Aggressive Variant Signature

This phase III trial compares the effect of adding carboplatin to the standard of care chemotherapy drug cabazitaxel versus cabazitaxel alone in treating prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castrate-resistant) and that has spread from where it first started (primary site) to other places in the body (metastatic). Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Chemotherapy drugs, such as cabazitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Prednisone is often given together with chemotherapy drugs. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs and to help the chemotherapy work. Giving carboplatin with the standard of care chemotherapy drug cabazitaxel may be better at treating metastatic castrate-resistant prostate cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare radiographic progression free survival (rPFS) between the two treatment arms in the subset of aggressive variant prostate cancer - molecular-pathologic signature (AVPC-MS)-positive participants.

II. If the AVPC-MS positive test is statistically significant, test in AVPC-MS negative participants whether the combination of carboplatin and cabazitaxel improves rPFS.

SECONDARY OBJECTIVES:

  1. To compare overall survival (OS) between the two treatment arms, stratified by AVPC-MS positive versus (vs.) negative.

II. To compare response rates for prostate specific antigen (PSA), total alkaline phosphatase, and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between the two treatment arms, stratified by AVPC-MS positive vs. negative.

III. To compare rPFS between the two treatment arms for the full trial. IV. To compare rPFS between the two treatment arms for the AVPC-MS negative group in the absence of a positive treatment effect in the AVPC-MS positive group.

  1. To compare progression free survival (PFS) between the two treatment arms, stratified by AVPC-MS positive vs. negative.

VI. To compare toxicities between the two arms in participants who receive any treatment on study.

BANKING OBJECTIVES:

  1. To bank specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive cabazitaxel intravenously (IV) over 60 minutes on day 1 of each cycle and prednisone orally (PO) twice daily (BID) on days 1-21 of each cycle. Cycles repeat every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.

ARM 2: Patients receive cabazitaxel and carboplatin IV over 60 minutes on day 1 of each cycle and prednisone PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.

All patients undergo blood sample collection, bone scan, computed tomography (CT), positron emission tomography (PET), or magnetic resonance imaging (MRI) throughout the trial and chest radiography (x-ray) before randomization.

After completion of study treatment, patients are followed every 12 weeks for 1 year after randomization, and then every 26 weeks for up to 4 years after randomization or until death, whichever occurs first.

Being tested
Biospecimen Collection, Bone Scan, Cabazitaxel, Carboplatin, Chest Radiography
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • CabazitaxelDrug

    Also called Jevtana, RPR-116258A, RPR116258A, Taxoid XRP6258

    Given IV

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • Chest RadiographyProcedure or surgery

    Also called Chest X-ray

    Undergo chest x-ray

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT or PET/CT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • PrednisoneDrug

    Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl

    Given PO

Study groups in NCT06470243
Study groupRoleWhat they receive
Arm 1 (cabazitaxel, prednisone)Active comparatorPatients receive cabazitaxel IV over 60 minutes on day 1 of each cycle and prednisone PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone scan, CT, PET, or MRI throughout the trial and chest x-ray before randomization.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Scan; Drug: Cabazitaxel; Procedure: Chest Radiography; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Drug: Prednisone
Arm 2 (cabazitaxel, carboplatin, prednisone)ExperimentalPatients receive cabazitaxel and carboplatin IV over 60 minutes on day 1 of each cycle and prednisone PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone scan, CT, PET, or MRI throughout the trial and chest x-ray before randomization.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Scan; Drug: Cabazitaxel; Drug: Carboplatin; Procedure: Chest Radiography; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic progression-free survival (rPFS)

    Will be assessed using response evaluation criteria in solid tumors (RECIST 1.1), progression of bone lesions using Prostate Cancer Working Group 2 (PCWG2) criteria, or occurrence of death due to any cause. RECIST 1.1 progression requires at least a 20% increase in the sum of diameters of target lesions and/or unequivocal progression of existing non-target lesions. PCWG2 bone lesion progression requires appearance of two or more new lesions seen on bone scan compared with bone scan at randomization.

    Measured: From date of randomization to the first documentation of rPFS event, assessed up to 5 years

Secondary outcomes (5)

  1. Prostate specific antigen (PSA) response

    Percentage of the subset of participants with a randomization PSA level of at least 5.0 ng/ml with a greater than 50% decrease in measurable values of PSA during treatment from the value measured at randomization.

    Measured: From study entry to first occurrence of rPFS or clinical progression, assessed up to 5 years

  2. Alkaline phosphatase response

    Percentage of participants with a greater than 50% decrease in measurable values of alkaline phosphatase during treatment from their value at randomization.

    Measured: From study entry to first occurrence of rPFS or clinical progression, assessed up to 5 years

  3. RECIST response

    Percentage of the subset of participants with measurable disease with an overall objective tumor response defined as a partial response (PR) or complete response (CR) according to RECIST version 1.1.

    Measured: From study entry to first occurrence of rPFS or clinical progression, assessed up to 5 years

  4. Progression-free survival

    Will be descriptively characterized between the two treatment arms. Survival curves will be estimated by the Kaplan-Meier method and a log-rank test will be used to compare both overall survival (OS) and PFS between the treatment arms, stratified by aggressive variant prostate cancer - molecular-pathologic signature (AVPC-MS) status.

    Measured: From study entry to first occurrence of rPFS or clinical progression, assessed up to 5 years

  5. OS

    Participants known to be alive are censored at date of last contact. Will be descriptively characterized between the two treatment arms. Survival curves will be estimated by the Kaplan-Meier method and a log-rank test will be used to compare both OS and PFS between the treatment arms, stratified by AVPC-MS status.

    Measured: From date of randomization to date of death due to any cause, assessed up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2024
  2. Study start27 Nov 2024
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completionApr 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
528 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06470243
Sponsor's protocol ID
S2312
Other IDs
NCI-2024-04336, S2312, S2312, U10CA180888
Status last verified
Jan 2026
First submitted
17 Jun 2024
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Biospecimen Collection, Bone Scan and Cabazitaxel in people with Castration-Resistant Prostate Carcinoma and Stage IVB Prostate Cancer AJCC v8, run by SWOG Cancer Research Network at 174 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 39 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 174 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic progression-free survival (rPFS) (time frame: From date of randomization to the first documentation of rPFS event, assessed up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06470243.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

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