Study on Brachytherapy for Prostate Cancer Patients

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT00525720

Provider View

This clinical trial is exploring whether a prostate implant, known as brachytherapy, can effectively control intermediate risk prostate cancer. The study will also assess the safety of this procedure, which involves placing radioactive seeds directly into the prostate to deliver radiation therapy.

Patient Parameters

Program Overview

The aim of this study is to determine if a prostate implant, called brachytherapy, can help manage intermediate risk prostate cancer. Brachytherapy involves inserting small radioactive seeds into the prostate to target cancer cells with radiation. The study will also evaluate the safety of this procedure.

Description

If you qualify for this study, you will first have an ultrasound of your prostate to measure and map it. This helps plan where the needles and seeds will be placed during the brachytherapy. The ultrasound is a quick, 20-minute outpatient procedure where a probe is inserted into the rectum to take pictures of the prostate.

Brachytherapy is done as an outpatient surgery. Under anesthesia, thin needles are inserted through the skin between the anus and scrotum to place the seeds into the prostate. An ultrasound probe stays in the rectum during the procedure to guide the needles. The seeds remain in the prostate permanently, while the needles are removed after placement. Typically, about 25 needles and 100 seeds are used. The procedure takes 1-2 hours, followed by a recovery period of 1-3 hours. A CT scan is done afterwards to ensure the seeds are correctly placed, and then you can go home.

After treatment, you will have a follow-up visit in 4-6 weeks, and then at 4, 8, and 12 months. After that, visits are every 6 months until 5 years post-treatment, and then annually. These visits include a physical exam, blood tests, and questionnaires about your urinary, bowel, and sexual health, as well as overall quality of life. A CT scan of the prostate will be done at the first follow-up visit to check the seed placement.

If blood tests show your cancer is worsening, a biopsy may be needed. This involves taking samples from the prostate using a needle, guided by an ultrasound probe in the rectum.

You will stay in the study unless your disease progresses. Up to 300 patients will participate, all at MD Anderson.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer, stage T1c - T2b, with no lymph node involvement or distant metastases.
  • Good overall health with a performance status of 0-1.
  • Aged 18 or older.
  • Intermediate risk prostate cancer, based on specific Gleason scores and PSA levels.
  • PSA level of 15 ng/ml or lower before joining the study.
  • Have not received hormone therapy.
  • Prostate size of 60 cc or less.
  • AUA symptom score of 15 or less (alpha blockers allowed).
  • Must sign an informed consent form before joining the study.

Exclusion Criteria

  • Prostate cancer stage lower than T1c or higher than T2b.
  • Lymph node involvement or distant metastases.
  • Previous radical prostate surgery, pelvic radiation, chemotherapy for prostate cancer, or certain prostate procedures.
  • Active prostatitis.

Locations

FACILITYZIPCITYSTATE
University of Texas MD Anderson Cancer Center77030HoustonTexas

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