Carboplatin with Cabazitaxel for Advanced Prostate Cancer

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

Recruiting Phase 3 Interventional Study
Castration-Resistant Prostate Carcinoma Stage IVB Prostate Cancer AJCC v8
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
528 (estimated)
Sponsor
SWOG Cancer Research Network · Research network
Who this trial is looking for

This trial is looking for men with advanced prostate cancer that is still growing despite low testosterone levels. Participants will be treated with two chemotherapy drugs, carboplatin and cabazitaxel, to see if they work better together than cabazitaxel alone.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with prostate cancer.
  • I have castrate-resistant prostate cancer that has spread to other parts of my body.
  • I have had treatment before that included docetaxel.
  • I have biopsy tissue to submit for testing.
  • I have evidence of metastatic prostate cancer from scans.
  • My testosterone levels are low.
  • I can give informed consent for participation.

You may not be able to join if

  • I have not been diagnosed with prostate cancer.
  • I do not have the required biopsy tissue for testing.
  • My testosterone levels are not low enough.
  • I have not received any prior treatments.
  • I am unable to give informed consent.
  • I have had recent treatment or surgery that affects my participation.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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). Carbop…
Trial Locations
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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)…
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