Study on High Dose Rate Brachytherapy Before Prostate Surgery in Prostate Cancer Patients

Sponsor: The Methodist Hospital Research Institute

Sponsor score: 0

ClinicalTrials ID:NCT07182279

Provider View

This clinical trial is testing whether adding a type of radiation therapy called high dose rate brachytherapy before surgery can help treat prostate cancer more effectively. The study is for patients with high-risk prostate cancer who are scheduled for surgery.

Patient Parameters

Program Overview

This study is exploring the use of high dose rate brachytherapy (HDR-B), a form of targeted radiation therapy, before prostate surgery in patients with high-risk prostate cancer. The goal is to see if this approach is safe and feasible, and to monitor how well patients follow the treatment plan. Patients will receive a single session of HDR-B 4-8 weeks before their scheduled prostate surgery. Some patients may also receive additional treatments after surgery, depending on their specific cancer characteristics.

Description

The study will include about 29 patients with high-risk prostate cancer. These patients will receive one session of high dose rate brachytherapy (HDR-B) with a dose of 15Gy, scheduled 4-8 weeks before their prostate surgery.

For patients with high-risk prostate cancer who have a high genomic risk score or cancer that has spread to nearby lymph nodes, additional treatments may be given after surgery. This includes three months of hormone therapy starting two months after surgery, and possibly radiation therapy to the pelvic area, which is standard care for these patients.

The main goals of the study are to determine if adding HDR-B before surgery is safe and feasible, and to see how well patients adhere to the treatment plan. Patients will be involved in the study for up to 27 months, including 2-3 months of active treatment and possibly an additional 3 months of hormone therapy. Follow-up visits will continue for up to 2 years after surgery to monitor patient health and treatment outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of prostate cancer through a biopsy.
  • Must have negative scans showing no spread of cancer to bones or other areas.
  • Must have one or more of the following risk factors:
    • PSA level of 20 or higher
    • Gleason score of 8 or higher
    • Cancer stage of T3a or higher
    • At least two of the following: PSA between 10-19.9, Gleason score of 4+3, cancer stage of T2b/T2c, or 50% or more positive biopsy samples.
  • Must agree to participate and sign an informed consent form.
  • Must be healthy enough for surgery and radiation therapy.
  • Must be 40 years or older.
  • Must have a performance status score of 0 or 1, indicating good overall health.
  • No history of other invasive cancers in the past 3 years, except for certain skin cancers or if disease-free for at least 2 years.
  • Must not have received hormone therapy in the past 6 months.

Exclusion Criteria

  • Cancer that has spread to other parts of the body.
  • High risk for anesthesia complications as determined by a doctor.
  • Previous radiation therapy to the pelvic area.
  • Prostate gland larger than 70 cc as measured by imaging tests.
  • High score on a urinary symptom questionnaire, even with medical treatment.
  • Recent hormone therapy within the past 6 months, except for certain medications stopped more than 3 months ago.
  • Unable or unwilling to follow the study procedures.

Locations

FACILITYZIPCITYSTATE
Houston Methodist77030HoustonTexas

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.