Study on Combining External and Internal Radiation Therapy for High-Risk Prostate Cancer

Sponsor: University of Virginia

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04465500

Provider View

This clinical trial is exploring whether a combination of hormone therapy, internal radiation, and external radiation can reduce side effects and improve outcomes for patients with high-risk prostate cancer.

Patient Parameters

Program Overview

The purpose of this study is to determine if using a combination of treatments—hormone therapy, MRI-guided internal radiation (HDR brachytherapy), and external radiation (EBRT)—can lead to fewer side effects and better results for patients with high-risk prostate cancer. The study will also look at how these treatments affect patients' quality of life and overall survival.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed consent and agree to follow study procedures.
  • Male, aged 18 or older.
  • Diagnosed with prostate cancer within the last year.
  • Classified as having unfavorable-intermediate, high, or very high-risk prostate cancer.
  • Completed a medical history and physical exam within the last 6 months.
  • PSA level less than 50 ng/mL before starting hormone therapy, measured within the last year. Exceptions may be made for certain circumstances like COVID-19.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Had a pelvic MRI within the last year.
  • Eligible to receive the combination of internal and external radiation, with or without hormone therapy, which may have started before joining the study.

Exclusion Criteria

  • Evidence of cancer spread to the bones.
  • Previous invasive cancer diagnosis unless disease-free for at least 3 years, except for non-melanoma skin cancer.
  • Previous prostate surgery or cryosurgery.
  • Previous radiation treatment to the pelvic area or prostate.
  • Previous chemotherapy for prostate cancer (chemotherapy for other cancers is allowed).
  • MRI incompatible metal implants that cannot be removed.
  • Severe or active health issues, including:
    • Recent severe heart problems or heart attack.
    • Serious infections needing IV antibiotics.
    • Severe lung disease or liver problems.
    • AIDS, due to potential immune system effects of the treatment.

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