RECRUITING

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

Conditions

Castration-Resistant Prostate Carcinoma Stage IVB Prostate Cancer AJCC v8

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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

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.

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

Quick Facts

Study Start:2024-12-12

Study Completion:2032-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06470243

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

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Paul Corn

PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Study Locations (Sites)

Highlands Oncology Group - Fayetteville

Fayetteville, Arkansas, 72703

United States

Highlands Oncology Group - Rogers

Rogers, Arkansas, 72758

United States

Highlands Oncology Group

Springdale, Arkansas, 72762

United States

Tibor Rubin VA Medical Center

Long Beach, California, 90822

United States

Beebe Medical Center

Lewes, Delaware, 19958

United States

Beebe South Coastal Health Campus

Millville, Delaware, 19967

United States

Helen F Graham Cancer Center

Newark, Delaware, 19713

United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713

United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718

United States

Beebe Health Campus

Rehoboth Beach, Delaware, 19971

United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, 19801

United States

Holy Cross Hospital

Fort Lauderdale, Florida, 33308

United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706

United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605

United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814

United States

Idaho Urologic Institute-Meridian

Meridian, Idaho, 83642

United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687

United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854

United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, 83864

United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704

United States

Illinois CancerCare-Canton

Canton, Illinois, 61520

United States

Memorial Hospital of Carbondale

Carbondale, Illinois, 62902

United States

SIH Cancer Institute

Carterville, Illinois, 62918

United States

Illinois CancerCare-Carthage

Carthage, Illinois, 62321

United States

Centralia Oncology Clinic

Centralia, Illinois, 62801

United States

Northwestern University

Chicago, Illinois, 60611

United States

University of Illinois

Chicago, Illinois, 60612

United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526

United States

Decatur Memorial Hospital

Decatur, Illinois, 62526

United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115

United States

Illinois CancerCare-Dixon

Dixon, Illinois, 61021

United States

Crossroads Cancer Center

Effingham, Illinois, 62401

United States

Illinois CancerCare-Eureka

Eureka, Illinois, 61530

United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401

United States

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401

United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134

United States

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, 60026

United States

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, 60030

United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443

United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045

United States

Illinois CancerCare-Macomb

Macomb, Illinois, 61455

United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269

United States

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 62269

United States

Northwestern Medicine Orland Park

Orland Park, Illinois, 60462

United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350

United States

Illinois CancerCare-Pekin

Pekin, Illinois, 61554

United States

Illinois CancerCare-Peoria

Peoria, Illinois, 61615

United States

Methodist Medical Center of Illinois

Peoria, Illinois, 61636

United States

Illinois CancerCare-Peru

Peru, Illinois, 61354

United States

Valley Radiation Oncology

Peru, Illinois, 61354

United States

Illinois CancerCare-Princeton

Princeton, Illinois, 61356

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

United States

Springfield Clinic

Springfield, Illinois, 62702

United States

Memorial Medical Center

Springfield, Illinois, 62781

United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555

United States

Illinois CancerCare - Washington

Washington, Illinois, 61571

United States

Reid Health

Richmond, Indiana, 47374

United States

Mercy Hospital

Cedar Rapids, Iowa, 52403

United States

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403

United States

Christiana Care - Union Hospital

Elkton, Maryland, 21921

United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106

United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114

United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114

United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188

United States

Trinity Health Medical Center - Canton

Canton, Michigan, 48188

United States

Caro Cancer Center

Caro, Michigan, 48723

United States

Chelsea Hospital

Chelsea, Michigan, 48118

United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118

United States

Hematology Oncology Consultants-Clarkston

Clarkston, Michigan, 48346

United States

Newland Medical Associates-Clarkston

Clarkston, Michigan, 48346

United States

Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236

United States

Great Lakes Cancer Management Specialists-Doctors Park

East China Township, Michigan, 48054

United States

Genesee Cancer and Blood Disease Treatment Center

Flint, Michigan, 48503

United States

Genesee Hematology Oncology PC

Flint, Michigan, 48503

United States

Genesys Hurley Cancer Institute

Flint, Michigan, 48503

United States

Hurley Medical Center

Flint, Michigan, 48503

United States

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

Grosse Pointe Woods, Michigan, 48236

United States

Henry Ford Saint John Hospital - Academic

Grosse Pointe Woods, Michigan, 48236

United States

Henry Ford Saint John Hospital - Breast

Grosse Pointe Woods, Michigan, 48236

United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912

United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154

United States

Great Lakes Cancer Management Specialists-Macomb Medical Campus

Macomb, Michigan, 48044

United States

Henry Ford Warren Hospital - Breast Macomb

Macomb, Michigan, 48044

United States

Saint Mary's Oncology/Hematology Associates of Marlette

Marlette, Michigan, 48453

United States

Hope Cancer Center

Pontiac, Michigan, 48341

United States

Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, 48341

United States

Newland Medical Associates-Pontiac

Pontiac, Michigan, 48341

United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341

United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601

United States

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, 48604

United States

MyMichigan Medical Center Tawas

Tawas City, Michigan, 48764

United States

Great Lakes Cancer Management Specialists-Macomb Professional Building

Warren, Michigan, 48093

United States

Henry Ford Madison Heights Hospital - Breast

Warren, Michigan, 48093

United States

Saint John Macomb-Oakland Hospital

Warren, Michigan, 48093

United States

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, 48661

United States

Huron Gastroenterology PC

Ypsilanti, Michigan, 48106

United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197

United States

Minnesota Oncology - Burnsville

Burnsville, Minnesota, 55337

United States

Cambridge Medical Center

Cambridge, Minnesota, 55008

United States

Mercy Hospital

Coon Rapids, Minnesota, 55433

United States

Fairview Southdale Hospital

Edina, Minnesota, 55435

United States

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, 55369

United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109

United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109

United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407

United States

Hennepin County Medical Center

Minneapolis, Minnesota, 55415

United States

Health Partners Inc

Minneapolis, Minnesota, 55454

United States

Monticello Cancer Center

Monticello, Minnesota, 55362

United States

New Ulm Medical Center

New Ulm, Minnesota, 56073

United States

Fairview Northland Medical Center

Princeton, Minnesota, 55371

United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, 55422

United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416

United States

Regions Hospital

Saint Paul, Minnesota, 55101

United States

United Hospital

Saint Paul, Minnesota, 55102

United States

Saint Francis Regional Medical Center

Shakopee, Minnesota, 55379

United States

Lakeview Hospital

Stillwater, Minnesota, 55082

United States

Ridgeview Medical Center

Waconia, Minnesota, 55387

United States

Rice Memorial Hospital

Willmar, Minnesota, 56201

United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, 55125

United States

Fairview Lakes Medical Center

Wyoming, Minnesota, 55092

United States

University of Mississippi Medical Center

Jackson, Mississippi, 39216

United States

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

United States

Southeast Cancer Center

Cape Girardeau, Missouri, 63703

United States

Parkland Health Center - Farmington

Farmington, Missouri, 63640

United States

Missouri Baptist Medical Center

Saint Louis, Missouri, 63131

United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670

United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080

United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127

United States

Community Hospital of Anaconda

Anaconda, Montana, 59711

United States

Billings Clinic Cancer Center

Billings, Montana, 59101

United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715

United States

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405

United States

Great Falls Clinic

Great Falls, Montana, 59405

United States

Kalispell Regional Medical Center

Kalispell, Montana, 59901

United States

Community Medical Center

Missoula, Montana, 59804

United States

Nebraska Medicine-Bellevue

Bellevue, Nebraska, 68123

United States

Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Indu and Raj Soin Medical Center

Beavercreek, Ohio, 45431

United States

Saint Elizabeth Boardman Hospital

Boardman, Ohio, 44512

United States

Dayton Physicians LLC-Miami Valley South

Centerville, Ohio, 45459

United States

Oncology Hematology Care Inc-Kenwood

Cincinnati, Ohio, 45236

United States

Dayton Physician LLC - Englewood

Dayton, Ohio, 45415

United States

Armes Family Cancer Center

Findlay, Ohio, 45840

United States

Blanchard Valley Hospital

Findlay, Ohio, 45840

United States

Orion Cancer Care

Findlay, Ohio, 45840

United States

Dayton Physicians LLC-Atrium

Franklin, Ohio, 45005

United States

Dayton Physicians LLC-Wayne

Greenville, Ohio, 45331

United States

Wayne Hospital

Greenville, Ohio, 45331

United States

Greater Dayton Cancer Center

Kettering, Ohio, 45409

United States

Kettering Medical Center

Kettering, Ohio, 45429

United States

Dayton Physicians LLC - Troy

Troy, Ohio, 45373

United States

Saint Joseph Warren Hospital

Warren, Ohio, 44484

United States

Saint Elizabeth Youngstown Hospital

Youngstown, Ohio, 44501

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Saint Alphonsus Cancer Care Center-Baker City

Baker City, Oregon, 97814

United States

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, 97914

United States

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103

United States

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017

United States

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, 19317

United States

Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301

United States

Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, 18201

United States

The West Clinic - Wolf River

Germantown, Tennessee, 38138

United States

MD Anderson in The Woodlands

Conroe, Texas, 77384

United States

Lyndon Baines Johnson General Hospital

Houston, Texas, 77026-1967

United States

M D Anderson Cancer Center

Houston, Texas, 77030

United States

MD Anderson West Houston

Houston, Texas, 77079

United States

MD Anderson League City

League City, Texas, 77573

United States

MD Anderson in Sugar Land

Sugar Land, Texas, 77478

United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235

United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

United States

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, 54017

United States

Billings Clinic-Cody

Cody, Wyoming, 82414

United States

Welch Cancer Center

Sheridan, Wyoming, 82801

United States

Collaborators and Investigators

Sponsor: SWOG Cancer Research Network

Paul Corn, PRINCIPAL_INVESTIGATOR, SWOG Cancer Research Network

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 Date2024-12-12

Study Completion Date2032-04

Study Record Updates

Study Start Date2024-12-12

Study Completion Date2032-04

Terms related to this study

Additional Relevant MeSH Terms

Castration-Resistant Prostate Carcinoma
Stage IVB Prostate Cancer AJCC v8