Comparing Two Radiation Treatments for Localized Prostate Cancer: High-Dose Rate Brachytherapy vs. Stereotactic Ablative Radiotherapy

Sponsor: Rutgers, The State University of New Jersey

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04253483

Provider View

This study is comparing two types of radiation treatments to see which one is better for patients with prostate cancer that hasn't spread. It focuses on how these treatments affect patients' quality of life.

Patient Parameters

Program Overview

This clinical trial is exploring two different radiation treatments for prostate cancer that hasn't spread beyond the prostate. One treatment, high-dose rate brachytherapy, involves placing a temporary radioactive seed directly into the prostate. The other, stereotactic ablative radiotherapy, uses external beams to deliver high doses of radiation over a few sessions. The study aims to determine which treatment provides a better quality of life for patients.

Description

The main goal of this study is to see if it's feasible to conduct a trial comparing two radiation treatments for localized prostate cancer: stereotactic ablative radiotherapy (SABR) and high-dose rate brachytherapy.

Participants can choose between two treatment options:

  • Option 1: High-dose rate brachytherapy, where radiation is delivered directly into the prostate.
  • Option 2: Stereotactic ablative radiotherapy (SABR), which involves receiving radiation every other day for a total of five treatments.

After completing the treatment, patients will have regular follow-up visits to monitor their progress.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer within the last 9 months.
  • Cancer is low-risk or intermediate-risk, defined as:
    • Clinical stage T1-T2, Gleason score of 7 or less, and PSA level under 15 ng/ml.
  • Optional lymph node evaluation by CT or MRI and bone scan.
  • Recommended but not required prostate MRI.
  • No use of alpha reductase inhibitors within 2 weeks before starting the study.
  • Good overall health with an ECOG status of 0 or 1.
  • Medically fit for brachytherapy as judged by a radiation oncologist.
  • No concurrent or additional hormone therapy allowed.
  • Prostate size of 60 cc or less by ultrasound.
  • IPSS score of 20 or less (alpha blockers allowed).
  • Must sign an informed consent form.
  • Must be available for treatment and follow-up at the study center.
  • Treatment must start within 4 weeks of joining the study.

Exclusion Criteria

  • History of other cancers, except for certain skin cancers or other solid tumors treated successfully over 5 years ago.
  • History of bleeding disorders.
  • Previous prostate surgery, pelvic radiation, chemotherapy, or other prostate cancer treatments.
  • Advanced cancer stage T3b or evidence of cancer spread.
  • Plans to receive other cancer treatments during the study.
  • Severe health conditions, such as recent heart issues, infections, or liver problems.
  • AIDS or other immune system issues.
  • History of inflammatory bowel diseases or certain autoimmune diseases.
  • Significant psychiatric illness.
  • Men who do not agree to use effective birth control methods.

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