Active — Not RecruitingPhase 2

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

United States120 participantsStarted 2020-12-29

Plain-language 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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Completion of informed consent prior to any study specific procedures * Patients must agree to tissue collection for correlative studies at the specified timepoints * Patients must consent to the MD Anderson Immunotherapy Platform laboratory protocol PA13-0291 * 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) * Patients must meet at least one of the following AVPC criteria: * Histologically proven small cell (neuroendocrine) prostate carcinoma * Exclusive visceral metastases * Predominantly lytic bone metastases identified by plain x-ray or CT scan * Bulky (\>= 5 cm in longest dimension) lymphadenopathy or high-grade tumor mass in prostate/pelvis * Low PSA (=\< 10 ng/mL) at initial presentation (prior to androgen ablation or at symptomatic progression in the castrate-setting) plus high volume (\>= 20) bone metastases * Elevated serum lactate dehydrogenase (LDH) (\>= 2 x ULN) or elevated serum carcinoembryonic antigen (CEA) (\>= 2 x ULN) in the absence of other etiologies * Short interval (=\< 180 days) to castrate-resistant progression following initiation of hormonal therapy * Known loss or mutation (by Clinical Laboratory Improvement Act \[CLIA\] certified molecular testing, immunohistochemistry \[IHC\] and/or deoxyribonucleic acid \[DNA\] sequencing) in at least 2 of Tp53,…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is specifically for 'aggressive variant' prostate cancer — can you help me understand whether my diagnosis actually fits that category, and what features would make me a candidate worth discussing with the study team?
2Since this is a Phase 2 trial, the treatment combination of cabazitaxel, carboplatin, cetrelimab, and then niraparib hasn't been fully tested for long-term safety yet — what known side effects from each of these drugs should I be aware of before considering whether this approach makes sense for my situation?
3The trial is active but no longer enrolling new patients — does that mean this combination or something similar might still be available to me through standard care, a compassionate use program, or a different trial?
4The primary goal being measured here is progression-free survival rather than overall survival — what does that mean practically for me, and how would you weigh that against what standard treatment options might offer?
5Given that this involves chemotherapy followed by a maintenance phase, how demanding is a regimen like this on daily life, and are there standard-of-care alternatives we should compare it against before exploring whether a similar trial or off-label approach might be right for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression-free survival

Timeframe: Time from randomization until documented disease progression, start of new therapy for prostate cancer in the absence of progression, or death in the absence of progression, whichever comes first, assessed up to 5 years

Trial details

NCT IDNCT04592237

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Aggressive Variant Prostate Carcinoma trials