A Study of the Experimental Medicine Niraparib for Men With High Risk Prostate Cancer

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Age: 18+
Gender:
Male
Healthy Volunteers: No
Keywords: prostate cancer, cancer, men's health, phase 2
Type: Drug Study
Target:
30 Participants
Investigator:
Description
You are being asked to take part in this study because:
- you have high-risk prostate cancer.
- there are alterations in your DNA repair pathways.
- you have chosen to have a prostatectomy (surgical removal of prostate) to treat your prostate cancer.

This study will test the effects of the experimental medicine Niraparib on your prostate cancer.

This study will test the impact of Niraparib therapy prior (neoadjuvant) to radical prostatectomy (RP).

Niraparib is currently being studied for the treatment of ovarian, breast and prostate cancer.

Niraparib is FDA approved to treat adult patients with epithelial, ovarian, fallopian tube, or primary peritoneal cancer. It has not yet been approved by the FDA for use in prostate cancer.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion Criteria Patients must meet all of the following criteria to be eligible for study entry.

  1. Ability to understand and willingness to sign an informed consent form.
  2. Ability to adhere to the study visit schedule and other protocol requirements.
  3. Men ≥18 years of age.
  4. Patients must have histologically or cytologically confirmed prostate cancer that is clinically localized as defined by negative cross-section imaging and/or bone scan, and classified as high or high risk per NCCN guidelines (see Appendix).
  5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1 (Appendix 1).
  6. Life expectancy ≥ 10 years.
  7. Men who have selected radical prostatectomy as the primary treatment for their prostate cancer.
  8. Prostate cancer tumors with alterations in key DNA repair genes identified on Foundation One assay. This will include at least one alteration in a gene involved in DNA repair primarily through the homologous recombination pathway including BRCA1/2, ATM, CDK12, CHEK1/2 FANCA, FANCD2, FANCL, GEN1, NBN, PALPB2, RAD51, RAD51c, and BRIP1. Mutations will be selected that are known or likely pathogenic. Mean allele frequencies will be assessed to estimate mono versus biallelic loss of function. Patients with biallelic deletions or mutations will be prioritized for inclusion to make up at least 30% of the enrollment (i.e., 10 patients) to gauge response in this group over monoallelic loss. Final inclusion will be determined by the principal investigator.
  9. Must be able to swallow whole capsules.
  10. To avoid risk of drug exposure through the ejaculate, male subjects (even if they have undergone a successful vasectomy) must agree while on study therapy (including during dose interruptions) and for 3 months following the last dose of study drug to: a. Use a condom during sexual activity or practice complete sexual abstinence, b. Not donate sperm
  11. The following laboratory results obtained ≤14 days of the first study treatment: a. Absolute neutrophil count (ANC) ≥ 1.5 × 109 /L, platelet count ≥ 100 × 109 /L, and hemoglobin ≥ 9 g/dL (may have been transfused) b. Liver function tests meeting the following criteria: total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and ALT levels ≤ 2.5 × ULN or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver). c. INR and aPTT ≤1.5 x ULN (for patients on anticoagulation they must be receiving a stable dose for at least 1 week prior to randomization) d. Creatinine clearance > 30 mL/min by Cockcroft-Gault formula (or local institutional standard method).

Exclusion Criteria Patients who meet any of the following criteria will be excluded from study entry.

  1. Any condition that would prohibit the understanding or rendering of informed consent.
  2. Prior treatment for prostate cancer.
  3. Prior treatment with a PARP inhibitor.
  4. Prior treatment with androgen deprivation therapy (LHRH agonist/antagonist), antiandrogen (e.g., bicalutamide, nilutamide, enzalutamide, apalutamide), or androgen synthesis inhibitor (e.g., abiraterone, orteronel).
  5. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  6. Uncontrolled concomitant disease that in the opinion of the investigator would interfere with the patient’s safety or compliance on trial.
  7. Severe infection that in the opinion of the investigator would interfere with the patient’s safety or compliance on trial within 4 weeks prior to enrollment.
  8. Known allergies, hypersensitivity, or intolerance to niraparib or its excipients (refer to Investigator's Brochure).
  9. Known disorder affecting gastrointestinal absorption.
  10. Corrected QT interval by the Fridericia correction formula (QTcF) on the screening ECG >450 msec.
  11. Receiving concomitant medications that prolong QTc and are unable to discontinue use while receiving study drug (see Appendix).
  12. History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes).
  13. Known HIV positive subjects with 1 or more of the following: a. Not receiving antiretroviral therapy b. A change in antiretroviral therapy within 6 months of the start of screening (except if, after consultation with the sponsor on exclusion criterion 14.c, a change is made to avoid a potential drug-drug interaction with the study drug) c. Receiving antiretroviral therapy that may interfere with the study drug (consult the PI for review of medication prior to enrollment) d. CD4 count <350 at screening e. An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study team will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You will be asked to participate for as long as your cancer is not growing and you are not having any unmanageable side effects. After you are finished taking Niraparib your doctor will ask you to visit the office for follow-up at least once. You will be followed for up to five years.
Recruitment period
From June 26, 2019
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • prostate cancer
  • cancer
  • men's health

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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