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 prostate cancer patients who plan to undergo surgery to have their prostate removed (radical prostatectomy) and whose cancer has one of the listed gene mutations: BRCA1, BRCA2, PALB2, RAD51B, RAD51C, RAD51D, RAD54L2, BARD1, FANCA or BRIP1.

This study is enrolling people with intermediate-risk or high-risk prostate cancer with the following gene mutations who are planning to undergo surgery to have their prostate removed (radical prostatectomy). An HRR mutation means there are mutations in the tumor tissue that the ability of their DNA 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 prostate cancer patients who plan to undergo surgery to have their prostate removed (radical prostatectomy).

The usual approach for patients with intermediate-risk or high-risk localized prostate 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 systemic therapy before surgery (also known as neoadjuvant therapy).

The purpose of this study is to see if giving patients a drug called olaparib (a type of targeted therapy known as a PARP inhibitor) in combination with a hormone therapy known as a luteinizing hormone-releasing hormone (LHRH) agonist (a standard of care drug for prostate 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 olaparib and an LHRH agonist for up to 6 months followed by surgery to remove the prostate.

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 prostate cancer              (adenocarcinoma) 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 BRCA1, BRCA2, PALB2, RAD51B, RAD51C, RAD51D, RAD54L2, BARD1, FANCA, BRIP1 mutation.
• Are candidates for a radical prostatectomy.

People cannot participate if they:

• Have previously been treated with a type of drug known as a PARP Inhibitor.
• Have previously been treated with hormone therapy for prostate. cancer including orchiectomy, antiandrogens, CYP17 (Cytochrome P450) inhibitors, estrogens and radiation therapy.
• Have metastatic disease.
• Other medical conditions that could impact treatment, which will be reviewed with you.