Study on Hormone Therapy with Enzalutamide and Abiraterone Using Advanced Scans for Newly Diagnosed Prostate Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03860987

Provider View

This clinical trial is exploring a new treatment approach for prostate cancer using hormone therapy combined with advanced imaging techniques to better detect and treat the disease before surgery.

Patient Parameters

Program Overview

This study aims to improve the detection and treatment of prostate cancer by combining hormone therapy drugs, enzalutamide and abiraterone, with advanced imaging techniques like MRI and PET/CT scans. The goal is to see if this combination can better locate and treat prostate cancer in men whose cancer has not spread beyond the prostate.

Description

Prostate cancer is a common cancer in men, and researchers are looking for better ways to treat it. This study combines two hormone therapy drugs, enzalutamide and abiraterone, to see if they can improve treatment outcomes when used before surgery. The study also uses advanced imaging techniques, such as MRI and PET/CT scans, to better detect prostate cancer.

Participants will take three medications daily and receive two injections during the study. They will have regular medical evaluations and imaging scans before treatment, two months after starting treatment, and before surgery. A special radiotracer will be injected before the PET/CT scan to help visualize the cancer.

Participants may also have a biopsy before treatment and two months after starting treatment. After six months of treatment, participants will undergo surgery to remove the prostate. Follow-up visits will occur three months after surgery and annually for five years to monitor PSA and testosterone levels.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 and older with a confirmed diagnosis of prostate cancer that has not spread beyond the prostate.
  • Prostate cancer must be intermediate or high risk, based on specific medical criteria such as PSA levels, Gleason score, or cancer stage.
  • Eligible for surgery to remove the prostate.
  • Testosterone levels of at least 100 ng/dL.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Adequate organ and blood function as determined by specific medical tests.
  • Willing to use effective contraception during and after the study to prevent pregnancy.
  • Able to understand and sign a consent form and willing to follow study requirements, including travel for follow-up visits.

Exclusion Criteria

  • Currently taking other investigational drugs or herbal medications.
  • Evidence of cancer spread beyond the prostate on imaging tests.
  • Previous treatment for prostate cancer, such as surgery or radiation.
  • Allergic reactions to study drugs or similar medications.
  • Significant heart disease or uncontrolled high blood pressure.
  • Conditions that make biopsy or MRI unsafe, such as bleeding disorders or metal implants.
  • Active infections or other serious health conditions that could interfere with the study.
  • HIV-positive patients on certain medications, unless stable and approved by the study team.
  • Active treatment for Hepatitis B or C.
  • Use of medications that interfere with study drugs.
  • Recent cancer other than prostate cancer that could affect study participation.

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