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NCT04592237 · ClinicalTrials.gov registry record · Phase 2

Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer

A Phase 2 study of Castration-Resistant Prostate Carcinoma and Metastatic Prostate Carcinoma, sponsored by M.D. Anderson Cancer Center.

Active
Registry status
Phase 2
Development phase
120
Enrollment target
1
Study location

NCT04592237: Active Phase 2 study of Castration-Resistant Prostate Carcinoma and Metastatic Prostate Carcinoma, sponsored by M.D. Anderson Cancer Center.

NCT04592237 is a Phase 2 study of Castration-Resistant Prostate Carcinoma and Metastatic Prostate Carcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 120 participants, above the 75-participant average among 43 other Castration-Resistant Prostate Carcinoma trials with a reported enrollment target (60% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04592237, a Phase 2 study of Castration-Resistant Prostate Carcinoma and Metastatic Prostate Carcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
120 participants
Enrollment target
1
Study location

Study Summary

This phase II trial studies the effect of cabazitaxel, carboplatin, and cetrelimab followed by niraparib with or without cetrelimab in treating patients with aggressive variant prostate cancer that has spread to other places in the body (metastatic). Chemotherapy drugs, such as cabazitaxel and carboplatin, 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. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as niraparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Immunotherapy with monoclonal antibodies, such as cetrelimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving niraparib with or without cetrelimab, after treatment with cabazitaxel, carboplatin, and cetrelimab, may help control aggressive variant prostate cancer.

Primary Outcome

Estimated by the methods of Kaplan and Meier. The 2 randomized treatment arms will be compared by a log rank test.

Conditions Studied

Castration-Resistant Prostate Carcinoma Metastatic Prostate Carcinoma Stage IV Prostate Cancer AJCC v8 Metastatic Prostate Neuroendocrine Carcinoma Aggressive Variant Prostate Carcinoma Metastatic Prostate Small Cell Carcinoma

Interventions

  • DRUG Carboplatin
  • DRUG Niraparib
  • DRUG Cabazitaxel
  • BIOLOGICAL Cetrelimab

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2020-12-29
Est. Completion 2027-12-31
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the registry record for NCT04592237 still lists

NCT04592237 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 75-participant average among 43 other Castration-Resistant Prostate Carcinoma trials with a reported enrollment target (60% higher).

The record links to 6 conditions, with Castration-Resistant Prostate Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.

NCT04592237 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT04592237 about?

NCT04592237 is a clinical study titled "Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer". This phase II trial studies the effect of cabazitaxel, carboplatin, and cetrelimab followed by niraparib with or without cetrelimab in treating patients with aggressive variant prostate cancer that has spread to other places in the body (metastatic). Chemotherapy drugs, such as cabazitaxel and carbo...

What is the current status of trial NCT04592237?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2020-12-29. Estimated completion is 2027-12-31.

What conditions does trial NCT04592237 study?

This clinical trial studies the following conditions: Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Metastatic Prostate Neuroendocrine Carcinoma, Aggressive Variant Prostate Carcinoma.

What interventions are being tested in trial NCT04592237?

The interventions under investigation include: Carboplatin (DRUG), Niraparib (DRUG), Cabazitaxel (DRUG), Cetrelimab (BIOLOGICAL).

Who is sponsoring clinical trial NCT04592237?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04592237 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Castration-Resistant Prostate Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04592237's enrollment target sits among peer trials

120 8th of 43 higher than 36 of 43 other Castration-Resistant Prostate Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Castration-Resistant Prostate Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04592237, the US trial registry maintained by the National Library of Medicine. NCT04592237 (mid enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.