Phase II Study on Gene and Hormone Therapies, Radiation, and Surgery for High-Risk Prostate Cancer

Sponsor: The Methodist Hospital Research Institute

Sponsor score: 0

ClinicalTrials ID:NCT03541928

Provider View

This clinical trial is exploring a combination of gene therapy, hormone therapy, radiation, and surgery to treat men with high-risk prostate cancer that has not been treated before.

Patient Parameters

Program Overview

The study aims to test the effectiveness and safety of a new treatment approach for high-risk prostate cancer. This includes a gene therapy called HSV-tk+ valacyclovir, combined with hormone therapy, internal and external radiation, and surgery. Researchers will monitor changes in PSA levels, physical exams, and tissue samples to evaluate the treatment's impact on cancer cells. Blood tests will also be conducted to check immune response and organ function. The study will track how well patients do over time, including cancer progression and survival rates.

Description

This trial is designed to evaluate a new treatment strategy for men with high-risk prostate cancer. The treatment combines gene therapy (HSV-tk+ valacyclovir) with hormone therapy, two types of radiation therapy, and surgery. Researchers will assess how well the treatment works by looking at changes in PSA levels, physical exams, and tissue samples from biopsies and surgeries. They will also collect blood samples to study immune responses and check liver function. The safety of the treatment will be evaluated using standard criteria for side effects. Patients will be closely monitored for cancer progression and overall survival.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of prostate cancer through a biopsy.
  • Must have high-risk features such as a PSA level over 20, a Gleason score of 8-10, or advanced cancer stage.
  • No previous treatments for prostate cancer, including surgery, hormone therapy, or radiation.
  • Must be in good general health with an ECOG performance status of 0 or 1.
  • No signs of cancer spread or other cancers, except for certain skin cancers.
  • Must have a PSA test within 3 months before joining the study.
  • Must agree to provide tissue samples for the study.
  • Must have normal organ function based on specific blood tests.
  • Must be willing to sign an informed consent form after understanding the study details.

Exclusion Criteria

  • No recent treatments with immune therapies or gene therapies within the last 3 months.
  • No recent chemotherapy, radiation, or experimental drugs within 3 weeks before starting the study.
  • No evidence of cancer spread.
  • Prostate size must be 50cc or smaller.
  • No previous prostate surgeries or pelvic radiation.
  • No previous hormone therapy, except for certain medications stopped more than 3 months ago.
  • No use of steroids or immune-suppressing drugs.
  • No history of liver disease or alcohol abuse in the past year.
  • No allergies to the study medications.
  • Must be able to swallow pills.
  • No other active cancers, except for certain skin or cervical cancers, or cancers treated and disease-free for over 5 years.
  • No active infections or immune system issues, including HIV.
  • Must be 18 years or older.
  • Must be willing and able to follow the study procedures.

Locations

FACILITYZIPCITYSTATE
Houston Methodist Hospital77030HoustonTexas

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