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Chemotherapy

Chemotherapy + PARP Inhibitor/Immunotherapy for Prostate Cancer

Phase 2

Waitlist Available

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

Histologically or cytologically confirmed prostate carcinoma

Presence of metastatic disease documented on imaging studies (bone scan, computed tomography [CT] and/or magnetic resonance imaging [MRI] scans)

Must not have

History or current diagnosis of MDS/AML

Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 prostate cancer diagnosis was confirmed through lab tests.

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My cancer has spread to other parts of my body, confirmed by scans.

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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 prostate cancer is getting worse, shown by tests or new symptoms.

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My cancer has specific genetic changes in Tp53, RB1, or PTEN.

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I am undergoing treatment to lower my testosterone levels below 50 ng/dL.

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My cancer has spread only to my internal organs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had myelodysplastic syndrome or acute myeloid leukemia.

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I cannot swallow pills or have a stomach condition that affects medication absorption.

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I have had lung inflammation or widespread lung disease not caused by cancer.

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I have active hepatitis or chronic liver disease.

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I have undergone more than one chemotherapy treatment.

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I am not allergic to niraparib, carboplatin, cabazitaxel, or any PD1/PDL1 inhibitors.

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I don't have uncontrolled brain tumors or spinal issues affecting my nerves.

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I have been treated for advanced prostate cancer with specific drugs or immunotherapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival

Secondary study objectives

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

Carboplatin

2014

Completed Phase 3

~6120

Niraparib

2018

Completed Phase 4

~2400