Study on Androgen Receptor Antagonist ARN-509 With or Without Additional Medications for High-Risk Prostate Cancer Patients Undergoing Surgery

Sponsor: Rutgers, The State University of New Jersey

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02949284

Provider View

This clinical trial is exploring how well the drug ARN-509 works, alone or with other medications, in treating high-risk prostate cancer in patients who are having surgery. The study aims to see if these treatments can better control cancer by reducing androgen levels, which fuel cancer growth.

Patient Parameters

Program Overview

This study is testing whether the drug ARN-509, used alone or with other medications like abiraterone acetate, a hormone therapy, and prednisone, can help treat high-risk prostate cancer in patients undergoing surgery. Androgens are hormones that can promote the growth of prostate cancer cells. By lowering androgen levels, these treatments may help control the cancer. The study will compare different treatment combinations to see which works best.

Description

The main goal of this study is to see if using the drug ARN-509, with or without other medications, can make it easier to perform a nerve-sparing prostate surgery in men with high-risk prostate cancer.

Participants will be randomly assigned to one of three groups:

  • Group 1: Participants will take ARN-509 by mouth every day for three months before having prostate surgery.
  • Group 2: Participants will receive a hormone shot on the first day, take ARN-509 by mouth daily, take abiraterone acetate by mouth daily, and take prednisone by mouth daily for three months before having prostate surgery.
  • Group 3: Participants will have prostate surgery without taking any of the study medications.

After finishing the study treatment, participants will be monitored for two years to check their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of prostate cancer with a Gleason score greater than 8 or a PSA level over 20, and more than one positive biopsy.
  • Be in good general health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a clinical stage of T3 or less, indicating the cancer is resectable.
  • Have adequate blood counts and organ function, including:
    • Hemoglobin level of at least 9.0 g/dL.
    • Platelet count of at least 100,000 x 10^9/uL.
    • Serum albumin level of at least 3.0 g/dL.
    • Kidney function with a GFR of at least 45 mL/min.
    • Serum potassium level of at least 3.5 mmol/L.
    • Liver function tests within specified limits.
  • Agree to use effective birth control methods during the study and for three months after the last dose of study medication.
  • Agree not to donate sperm during the study and for three months after the last dose of study medication.

Exclusion Criteria

  • Have a clinical stage of T4, indicating the cancer has invaded the rectum or ureters, making surgery more complicated.
  • Have a history of seizures or conditions that may increase the risk of seizures, such as a recent stroke or certain brain conditions.
  • Have had severe heart problems, like a heart attack or unstable angina, within six months before joining the study.
  • Have had blood clots or significant heart rhythm problems within six months before joining the study.
  • Have metastatic prostate cancer, meaning the cancer has spread to other parts of the body.
  • Have moderate or severe liver impairment.

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