🔎 Trials Near Me

Home › Prostate Cancer › NCT06470243

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

RecruitingPhase 3

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

Who can join

Ages 18 and older · Men

Full eligibility criteria
Inclusion Criteria:

* 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
* 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

About the study

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.

What is being tested

Sponsor: SWOG Cancer Research Network · Participants: 528 · Started: Nov 27, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06470243

Locations in the U.S.

ArkansasHighlands Oncology Group - Fayetteville, Fayetteville
Highlands Oncology Group - Rogers, Rogers
Highlands Oncology Group, Springdale
CaliforniaTibor Rubin VA Medical Center, Long Beach
DelawareBeebe Medical Center, Lewes
Beebe South Coastal Health Campus, Millville
Christiana Care Health System-Christiana Hospital, Newark
Helen F Graham Cancer Center, Newark
Medical Oncology Hematology Consultants PA, Newark
Beebe Health Campus, Rehoboth Beach
Christiana Care Health System-Wilmington Hospital, Wilmington
FloridaHoly Cross Hospital, Fort Lauderdale
IdahoSaint Alphonsus Cancer Care Center-Boise, Boise
Saint Alphonsus Cancer Care Center-Caldwell, Caldwell
Kootenai Health - Coeur d'Alene, Coeur d'Alene
Idaho Urologic Institute-Meridian, Meridian
Saint Alphonsus Cancer Care Center-Nampa, Nampa
Kootenai Clinic Cancer Services - Post Falls, Post Falls
Kootenai Clinic Cancer Services - Sandpoint, Sandpoint
IllinoisIllinois CancerCare-Bloomington, Bloomington
Illinois CancerCare-Canton, Canton
Memorial Hospital of Carbondale, Carbondale
SIH Cancer Institute, Carterville
Illinois CancerCare-Carthage, Carthage
Centralia Oncology Clinic, Centralia
Northwestern University, Chicago
University of Illinois, Chicago
Northwestern Medicine Cancer Center Kishwaukee, DeKalb
Cancer Care Specialists of Illinois - Decatur, Decatur
Decatur Memorial Hospital, Decatur
Illinois CancerCare-Dixon, Dixon
Crossroads Cancer Center, Effingham
Illinois CancerCare-Eureka, Eureka
Illinois CancerCare-Galesburg, Galesburg
Western Illinois Cancer Treatment Center, Galesburg
Northwestern Medicine Cancer Center Delnor, Geneva
Northwestern Medicine Glenview Outpatient Center, Glenview
Northwestern Medicine Grayslake Outpatient Center, Grayslake
Illinois CancerCare-Kewanee Clinic, Kewanee
Northwestern Medicine Lake Forest Hospital, Lake Forest
Illinois CancerCare-Macomb, Macomb
Cancer Care Center of O'Fallon, O'Fallon
HSHS Saint Elizabeth's Hospital, O'Fallon
Northwestern Medicine Orland Park, Orland Park
Illinois CancerCare-Ottawa Clinic, Ottawa
Illinois CancerCare-Pekin, Pekin
Illinois CancerCare-Peoria, Peoria
Methodist Medical Center of Illinois, Peoria
Illinois CancerCare-Peru, Peru
Valley Radiation Oncology, Peru
Illinois CancerCare-Princeton, Princeton
Memorial Medical Center, Springfield
Southern Illinois University School of Medicine, Springfield
Springfield Clinic, Springfield
Northwestern Medicine Cancer Center Warrenville, Warrenville
Illinois CancerCare - Washington, Washington
IndianaReid Health, Richmond
IowaMercy Hospital, Cedar Rapids
Oncology Associates at Mercy Medical Center, Cedar Rapids
MarylandChristiana Care - Union Hospital, Elkton
MichiganTrinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor
Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton
Trinity Health Medical Center - Brighton, Brighton
Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton
Trinity Health Medical Center - Canton, Canton
Caro Cancer Center, Caro
Chelsea Hospital, Chelsea
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea
Hematology Oncology Consultants-Clarkston, Clarkston
Newland Medical Associates-Clarkston, Clarkston
Henry Ford Health Saint John Hospital, Detroit
Great Lakes Cancer Management Specialists-Doctors Park, East China Township
Genesee Cancer and Blood Disease Treatment Center, Flint
Genesee Hematology Oncology PC, Flint
Genesys Hurley Cancer Institute, Flint
Hurley Medical Center, Flint
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center, Grosse Pointe Woods
Henry Ford Saint John Hospital - Academic, Grosse Pointe Woods
Henry Ford Saint John Hospital - Breast, Grosse Pointe Woods
University of Michigan Health - Sparrow Lansing, Lansing
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia
Great Lakes Cancer Management Specialists-Macomb Medical Campus, Macomb
Henry Ford Warren Hospital - Breast Macomb, Macomb
Saint Mary's Oncology/Hematology Associates of Marlette, Marlette
Hope Cancer Center, Pontiac
Michigan Healthcare Professionals Pontiac, Pontiac
Newland Medical Associates-Pontiac, Pontiac
Trinity Health Saint Joseph Mercy Oakland Hospital, Pontiac
MyMichigan Medical Center Saginaw, Saginaw
Oncology Hematology Associates of Saginaw Valley PC, Saginaw
MyMichigan Medical Center Tawas, Tawas City
Great Lakes Cancer Management Specialists-Macomb Professional Building, Warren
Henry Ford Madison Heights Hospital - Breast, Warren
Saint John Macomb-Oakland Hospital, Warren
Saint Mary's Oncology/Hematology Associates of West Branch, West Branch
Huron Gastroenterology PC, Ypsilanti
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti
MinnesotaMinnesota Oncology - Burnsville, Burnsville
Cambridge Medical Center, Cambridge
Mercy Hospital, Coon Rapids
Fairview Southdale Hospital, Edina
Fairview Clinics and Surgery Center Maple Grove, Maple Grove
Minnesota Oncology Hematology PA-Maplewood, Maplewood
Saint John's Hospital - Healtheast, Maplewood
Abbott-Northwestern Hospital, Minneapolis
Health Partners Inc, Minneapolis
Hennepin County Medical Center, Minneapolis
Monticello Cancer Center, Monticello
New Ulm Medical Center, New Ulm
Fairview Northland Medical Center, Princeton
North Memorial Medical Health Center, Robbinsdale
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park
Regions Hospital, Saint Paul
United Hospital, Saint Paul
Saint Francis Regional Medical Center, Shakopee
Lakeview Hospital, Stillwater
Ridgeview Medical Center, Waconia
Rice Memorial Hospital, Willmar
Minnesota Oncology Hematology PA-Woodbury, Woodbury
Fairview Lakes Medical Center, Wyoming
MississippiUniversity of Mississippi Medical Center, Jackson
MissouriSaint Francis Medical Center, Cape Girardeau
Southeast Cancer Center, Cape Girardeau
Parkland Health Center - Farmington, Farmington
Sainte Genevieve County Memorial Hospital, Sainte Genevieve
Missouri Baptist Medical Center, St Louis
Missouri Baptist Sullivan Hospital, Sullivan
BJC Outpatient Center at Sunset Hills, Sunset Hills
MontanaCommunity Hospital of Anaconda, Anaconda
Billings Clinic Cancer Center, Billings
Bozeman Health Deaconess Hospital, Bozeman
Benefis Sletten Cancer Institute, Great Falls
Great Falls Clinic, Great Falls
Kalispell Regional Medical Center, Kalispell
Community Medical Center, Missoula
NebraskaNebraska Medicine-Bellevue, Bellevue
Nebraska Medicine-Village Pointe, Omaha
University of Nebraska Medical Center, Omaha
OhioIndu and Raj Soin Medical Center, Beavercreek
Saint Elizabeth Boardman Hospital, Boardman
Dayton Physicians LLC-Miami Valley South, Centerville
Oncology Hematology Care Inc-Kenwood, Cincinnati
Dayton Physician LLC - Englewood, Dayton
Armes Family Cancer Center, Findlay
Blanchard Valley Hospital, Findlay
Orion Cancer Care, Findlay
Dayton Physicians LLC-Atrium, Franklin
Dayton Physicians LLC-Wayne, Greenville
Wayne Hospital, Greenville
Greater Dayton Cancer Center, Kettering
Kettering Medical Center, Kettering
Dayton Physicians LLC - Troy, Troy
Saint Joseph Warren Hospital, Warren
Saint Elizabeth Youngstown Hospital, Youngstown
OklahomaUniversity of Oklahoma Health Sciences Center, Oklahoma City
OregonSaint Alphonsus Cancer Care Center-Baker City, Baker City
Saint Alphonsus Cancer Care Center-Ontario, Ontario
PennsylvaniaLehigh Valley Hospital-Cedar Crest, Allentown
Lehigh Valley Hospital - Muhlenberg, Bethlehem
Christiana Care Health System-Concord Health Center, Chadds Ford
Pocono Medical Center, East Stroudsburg
Lehigh Valley Hospital-Hazleton, Hazleton
TennesseeThe West Clinic - Wolf River, Germantown
TexasMD Anderson in The Woodlands, Conroe
Lyndon Baines Johnson General Hospital, Houston
M D Anderson Cancer Center, Houston
MD Anderson West Houston, Houston
MD Anderson League City, League City
MD Anderson in Sugar Land, Sugar Land
VirginiaVCU Massey Cancer Center at Stony Point, Richmond
Virginia Commonwealth University/Massey Cancer Center, Richmond
WisconsinCancer Center of Western Wisconsin, New Richmond
WyomingBillings Clinic-Cody, Cody
Welch Cancer Center, Sheridan

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.