Clinicaltrials.gov identifier:
NCT05498272
Treatment
Treatment study for people with intermediate- or high-risk prostate cancer with certain tumor mutations
Study Contact Information:
Hoosier Cancer Research Network at studies@hoosiercancer.org or (317) 634-5842
NePtune: Using PARP Inhibitors Before Surgery in Localized Prostate Cancer
About the Study
This is a single-arm study, which means all patients will receive the same treatment. All patients will know which intervention or medication they are receiving during the study. This research study is enrolling cancer patients who plan to undergo surgery to have their removed (radical prostatectomy) and whose cancer has one of the listed gene mutations: , , , RAD51B, , , RAD54L2, , FANCA or .
This study is enrolling people with intermediate-risk or high-risk cancer with the following gene mutations who are planning to undergo surgery to have their removed (radical prostatectomy). An HRR mutation means there are mutations in the tumor tissue that the ability of their to repair the pathway that prevents the cancer from growing is not working. The study will look for any signs of cancer in tissue samples removed during surgery, after treatment (pathologic complete response rate), and measure the number of cancer cells that remain in the body during or after treatment (minimal residual disease).
What the Study Entails
This research study is for cancer patients who plan to undergo surgery to have their removed (radical prostatectomy).
The usual approach for patients with intermediate-risk or high-risk localized cancer is to undergo a radical prostatectomy without any systemic treatment (cancer treatment given throughout the body). This study will look at effects of giving before surgery (also known as therapy).
The purpose of this study is to see if giving patients a drug called (a type of known as a ) in combination with a hormone therapy known as a luteinizing hormone-releasing hormone (LHRH) agonist (a standard of care drug for cancer that works by stopping the production of testosterone) will
- decrease the amount of disease present when patients have surgery, and
- decrease the risk of the disease coming back after surgery.
The goal is to try to keep the cancer inactive for a longer period of time.
Participation in this study is entirely voluntary.
Treatment
Participation in the study is expected to be about 3 years. People enrolled in the study will get an oral medication known as and an LHRH agonist for up to 6 months followed by surgery to remove the .
There will be a clinic visit about 30 days after the surgery to see how the study participant is doing. After that visit, the patient’s doctor will determine the monitoring plan following surgery.
Follow Up
The study team will continue to collect information on the participant’s condition every 6 months for 3 years via phone call, email, checking medical records or through another avenue as appropriate. Each study visit can last from approximately one to three hours.
Study Locations
California
University of California San Diego
Site Study Coordinator: Arlene Araneta
Email: aaraneta@health.ucsd.edu
Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Site Study Coordinator: Sandra Moore- Cooper
Email: mooresa@jhmi.edu
Phone #: 410-955-0009
New York
Columbia University Irving Medical Center
Site Study Coordinator: Peyton Johnston
Email: pj2431@cumc.columbia.edu
Phone #: 212-305-1916
Memorial Sloan Kettering Cancer Center
Site Study Coordinator: Passang Lama
Email: lamap@mskcc.org
Phone #: 631-212-6320
Ohio
University of Cincinnati
Site Study Coordinator: Jessica Harpel
Email: harpelja@ucmail.uc.edu
Phone #: 513-584-6643
Pennsylvania
Penn Medicine Abramson Cancer Center
Site Study Coordinator: Jennifer Louie
Email: jennifer.louie2@pennmedicine.upenn.edu
Lead Researchers/Study PIs and Affiliation
Rana R. McKay, MD
Medical Oncologist
University of California San Diego
(858) 657-7876
People diagnosed with cancer () who are 18 years and older who:
- Provide written informed consent and HIPPA authorization (a detailed document which explains specific uses and disclosures of protected health information) of personal health information prior to registration.
- Must have evidence of an inherited or acquired , , , RAD51B, , , RAD54L2, , FANCA, mutation.
- Are candidates for a radical prostatectomy.
People cannot participate if they:
- Have previously been treated with a type of drug known as a .
- Have previously been treated with hormone therapy for . cancer including orchiectomy, antiandrogens, CYP17 (Cytochrome P450) inhibitors, estrogens and radiation therapy.
- Have disease.
- Other medical conditions that could impact treatment, which will be reviewed with you.