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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
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 belowSelect...
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:Select...
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
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 moreTrial 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
~6670
Niraparib
2018
Completed Phase 4
~1540
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
3,002 Previous Clinical Trials
1,794,159 Total Patients Enrolled
96 Trials studying Prostate Cancer
29,740 Patients Enrolled for Prostate Cancer
Janssen PharmaceuticaIndustry Sponsor
40 Previous Clinical Trials
9,346 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow the study's requirements, including treatments and visits.My prostate cancer diagnosis was confirmed through lab tests.Your total bilirubin level must be within a certain range, unless you have a condition called Gilbert's disease.My white blood cell count is within the required range for treatment.I don't have major side effects from past cancer treatments that haven't gone away.I have recovered from side effects of cancer treatment, except for specific prostate cancer therapies.Your white blood cell count is higher than 3 x 10^9/L, unless it's because of cancer spreading to your bone marrow, in which case a count higher than 2 x 10^9/L is allowed.I have or had myelodysplastic syndrome or acute myeloid leukemia.I cannot swallow pills or have a stomach condition that affects medication absorption.My prostate cancer is worsening even though my PSA levels are not high.I have had lung inflammation or widespread lung disease not caused by cancer.My cancer has spread to other parts of my body, confirmed by scans.I can swallow pills without any difficulty.Patients must meet at least one of the following AVPC criteria:I can take care of myself but might not be able to do heavy physical work.I do not have any health or mental conditions that would make this study unsafe for me.My prostate cancer is getting worse, shown by tests or new symptoms.I haven't taken strong immune system suppressing drugs in the last 28 days, except for small doses of steroids or allergy/scan pre-meds.I agree to use birth control and barrier protection during and after the study as required.I have or had an autoimmune or inflammatory disorder.I do not have any ongoing infections that are not under control.I have active hepatitis or chronic liver disease.I have undergone more than one chemotherapy treatment.I have not received any live vaccines within the last 30 days.You are required to stay in a hospital for treatment of a mental or physical illness.My hemoglobin level is at least 10 g/dL, or above 8 g/dL if my cancer has spread to my bone marrow.I am not allergic to niraparib, carboplatin, cabazitaxel, or any PD1/PDL1 inhibitors.My platelet count is healthy or acceptable for treatment.I don't have uncontrolled brain tumors or spinal issues affecting my nerves.My cancer has specific genetic changes in Tp53, RB1, or PTEN.My liver function tests are within the required range.I am undergoing treatment to lower my testosterone levels below 50 ng/dL.My kidney function, measured by creatinine clearance, is adequate.Your recent blood test doesn't show signs of myelodysplastic syndrome or acute myeloid leukemia.I have been treated for advanced prostate cancer with specific drugs or immunotherapies.I do not have another cancer with a high chance of returning within 2 years, except for certain skin, cervical, or bladder cancers.My cancer has spread only to my internal organs.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (niraparib)
- Group 2: Group II (cetrelimab, niraparib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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