NCT06470243

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

Recruiting now Phase 3 Last updated 21 January 2026

What this trial tests

Phase 3 trial testing Biospecimen Collection in Castration-Resistant Prostate Carcinoma in 528 participants. Currently enrolling.

Timeline

27 November 2024

Primary endpoint
30 June 2029

1 April 2034

Quick facts

Lead sponsor	SWOG Cancer Research Network
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	528
Start date	27 November 2024
Primary completion	30 June 2029
Estimated completion	1 April 2034
Sites	174 locations across United States

Drugs / interventions tested

• Biospecimen Collection — full drug profile →
• Bone Scan — full drug profile →
• Cabazitaxel (cabazitaxel) — full drug profile →
• Carboplatin (Carboplatin) — full drug profile →
• Chest Radiography
• Computed Tomography
• Magnetic Resonance Imaging
• Positron Emission Tomography
• Prednisone (prednisone) — full drug profile →

Conditions studied

• Castration-Resistant Prostate Carcinoma — all drugs for Castration-Resistant Prostate Carcinoma →
• Stage IVB Prostate Cancer AJCC v8 — all drugs for Stage IVB Prostate Cancer AJCC v8 →

Sponsor

SWOG Cancer Research Network

Who can join

18 and older, male only, with Castration-Resistant Prostate Carcinoma or Stage IVB Prostate Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Radiographic progression-free survival (rPFS)
  Time frame: From date of randomization to the first documentation of rPFS event, assessed up to 5 years
  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 re

Sponsor's own 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Prognostic Significance of <i>RB1</i> Alterations on Outcomes in Metastatic Prostate Cancer.
   Raychaudhuri R, Garraway IP, Maxwell KN, Rettig M, et al · · 2025 · cited 1× · PMID 40971752 · DOI 10.1200/po-25-00341