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Chemotherapy

Chemotherapy + PARP Inhibitor/Immunotherapy for Prostate Cancer

Phase 2
Recruiting
Led By Ana Aparicio
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Exclusive visceral metastases
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is studying 3 chemotherapy drugs given together, followed by a PARP inhibitor with or without an immunotherapy drug, to see if it can help control aggressive variant prostate cancer.

Who is the study for?
This trial is for men with aggressive variant metastatic prostate cancer who can swallow pills, have documented disease progression, and are willing to undergo treatment and follow-up. They must not have used immunosuppressive medication recently or had more than one chemotherapy line. Participants need functioning major organs and controlled infections, without certain medical conditions like uncontrolled heart issues or autoimmune disorders.Check my eligibility
What is being tested?
The study tests cabazitaxel, carboplatin, and cetrelimab followed by niraparib with or without cetrelimab. It aims to see if this combination can control the spread of aggressive prostate cancer by damaging tumor cells' DNA repair mechanisms and boosting the immune system's ability to fight cancer.See study design
What are the potential side effects?
Possible side effects include allergic reactions to drugs, fatigue, digestive problems like nausea or constipation from chemotherapy; blood-related issues such as anemia; increased risk of infection due to weakened immunity; liver function changes; potential inflammation from immunotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has spread only to my internal organs.
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I am willing and able to follow the study's requirements, including treatments and visits.
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My prostate cancer diagnosis was confirmed through lab tests.
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I can swallow pills without any difficulty.
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My cancer has spread to other parts of my body, confirmed by scans.
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My prostate cancer is getting worse, shown by tests or new symptoms.
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My prostate cancer is worsening even though my PSA levels are not high.
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I can take care of myself but might not be able to do heavy physical work.
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My hemoglobin level is at least 10 g/dL, or above 8 g/dL if my cancer has spread to my bone marrow.
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I agree to use birth control and barrier protection during and after the study as required.
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My platelet count is healthy or acceptable for treatment.
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My cancer has specific genetic changes in Tp53, RB1, or PTEN.
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My liver function tests are within the required range.
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I am undergoing treatment to lower my testosterone levels below 50 ng/dL.
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My kidney function, measured by creatinine clearance, is adequate.
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My white blood cell count is within the required range for treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival
Secondary outcome measures
Incidence of adverse events
Overall survival (OS)
Response rate
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group II (cetrelimab, niraparib)Experimental Treatment4 Interventions
INDUCTION: Patients receive cabazitaxel IV over 60 minutes and carboplatin IV over 60 minutes on day 1. Beginning cycle 2, patients also receive cetrelimab IV over 30-60 minutes on day 1. Treatment repeats for up to 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive cetrelimab IV over 30 minutes on day 1 and niraparib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Group I (niraparib)Experimental Treatment4 Interventions
INDUCTION: Patients receive cabazitaxel IV over 60 minutes and carboplatin IV over 60 minutes on day 1. Beginning cycle 2, patients also receive cetrelimab IV over 30-60 minutes on day 1. Treatment repeats for up to 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive niraparib orally PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~1540
Carboplatin
2014
Completed Phase 3
~6670
Cabazitaxel
2014
Completed Phase 3
~1290
Cetrelimab
2022
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,946 Previous Clinical Trials
1,803,314 Total Patients Enrolled
96 Trials studying Prostate Cancer
29,742 Patients Enrolled for Prostate Cancer
Janssen PharmaceuticaIndustry Sponsor
39 Previous Clinical Trials
9,295 Total Patients Enrolled
2 Trials studying Prostate Cancer
835 Patients Enrolled for Prostate Cancer
Ana AparicioPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
301 Total Patients Enrolled

Media Library

Cabazitaxel (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04592237 — Phase 2
Prostate Cancer Research Study Groups: Group II (cetrelimab, niraparib), Group I (niraparib)
Prostate Cancer Clinical Trial 2023: Cabazitaxel Highlights & Side Effects. Trial Name: NCT04592237 — Phase 2
Cabazitaxel (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04592237 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this research still open?

"As per information on clinicaltrials.gov, the trial is presently recruiting participants with its first posting date being December 29th 2020 and an update made February 10th 2022."

Answered by AI

What clinical applications is Cetrelimab commonly employed for?

"Cetrelimab is the most widely used therapeutic for melanoma, and can also be beneficial in treating other ailments such as lymphoma, non-hodgkin's disease and advanced sarcoma."

Answered by AI

How many participants are being welcomed into this medical experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, this medical trial was first posted on December 29th 2020 and is actively searching for patients to enrol in the study; 120 subjects are needed from a single site."

Answered by AI

What potential risks accompany the utilization of Cetrelimab?

"A score of 2 was assigned to Cetrelimab's safety due to the evidence collected in this Phase 2 trial which demonstrated its security yet lacks any efficacy data."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
~44 spots leftby Dec 2025