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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

ConditionsCastration-Resistant Prostate CarcinomaStage IVB Prostate Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorSWOG Cancer Research Network

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Scan

    Procedure/Surgery

    Undergo bone scan

  • Cabazitaxel

    Drug

    Given IV

  • Carboplatin

    Drug

    Given IV

  • Chest Radiography

    Procedure/Surgery

    Undergo chest x-ray

  • Computed Tomography

    Procedure/Surgery

    Undergo CT or PET/CT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Prednisone

    Drug

    Given PO

Treatment groups

528 Participants
are divided into 2 treatment groups
Group A: Arm 1 (cabazitaxel, prednisone)Active comparator 8 interventions
Group B: Arm 2 (cabazitaxel, carboplatin, prednisone)Experimental treatment 9 interventions

Trial outcomes

Primary outcomes

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.

Time frame
From date of randomization to the first documentation of rPFS event, assessed up to 5 years

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SWOG Cancer Research Network

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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