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Chemotherapy + PARP Inhibitor/Immunotherapy for Prostate Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Group I (niraparib)
- Group 2: Group II (cetrelimab, niraparib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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