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OncoMatch/Clinical Trials/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

Is NCT06470243 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Cabazitaxel and Carboplatin for castration-resistant prostate carcinoma.

Phase 3RecruitingSWOG Cancer Research NetworkNCT06470243Data as of May 2026

Treatment: Cabazitaxel · Carboplatin · PrednisoneThis 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.

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Biomarker criteria

Required: TP53 AVPC-Molecular Pathologic Signature immunohistochemistry (MSIHC) status

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

Required: RB1 AVPC-Molecular Pathologic Signature immunohistochemistry (MSIHC) status

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

Required: PTEN AVPC-Molecular Pathologic Signature immunohistochemistry (MSIHC) status

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

Disease stage

Required: Stage IVB

Metastatic disease required

Performance status

ZUBROD 0–2

Prior therapy

Min 1 prior line

Must have received: taxane (docetaxel) — castrate-sensitive and/or castrate-resistant disease state

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

Cannot have received: taxane (cabazitaxel)

Participants must not have received prior cabazitaxel

Cannot have received: platinum-based chemotherapy (carboplatin)

Participants must not have received prior...carboplatin

Lab requirements

Blood counts

Absolute neutrophil count ≥ 1.5 x 10^3/uL; 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)

Kidney function

calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault Formula

Liver function

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; AST/ALT ≤ 3 × institutional ULN (or if participant has liver metastases and/or acute tumor-associated illness, ≤ 4x institutional ULN)

Absolute neutrophil count ≥ 1.5 x 10^3/uL (within 28 days prior to 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); 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); 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); calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault Formula

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Illinois CancerCare-Eureka · Eureka, Illinois
  • Illinois CancerCare-Galesburg · Galesburg, Illinois
  • Western Illinois Cancer Treatment Center · Galesburg, Illinois
  • Northwestern Medicine Cancer Center Delnor · Geneva, Illinois
  • Northwestern Medicine Glenview Outpatient Center · Glenview, Illinois

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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