Pilot Study on High-Dose Radiotherapy for Intermediate Risk Prostate Cancer

Sponsor: Albert Einstein College of Medicine

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04147806

Provider View

This study is testing two different high-dose radiotherapy methods to see how well they work and how safe they are for men with intermediate-risk prostate cancer. The study will compare the effects of giving the treatment in either five sessions or a single session.

Patient Parameters

Program Overview

The study aims to evaluate the outcomes and side effects of two high-dose radiotherapy methods for men with intermediate-risk prostate cancer. Using advanced technology, the study will deliver precise radiation to the prostate while minimizing exposure to surrounding tissues. Participants will be randomly assigned to receive either five doses of radiation over a week or a single high dose. The study will monitor patients' health and cancer response through regular follow-ups, including PSA tests and MRI scans, over several years.

Description

This study is exploring a new way to treat intermediate-risk prostate cancer using high-dose radiotherapy. Participants will receive either five doses of radiation over one week or a single high dose. The goal is to see which method is more effective and has fewer side effects.

Patients will be closely monitored for any side effects, especially those affecting urinary, rectal, and sexual functions. Regular follow-ups will include PSA blood tests and MRI scans to track the cancer's response to treatment. A biopsy will be done two years after treatment to check how well the cancer has responded. The study will last for at least five years, and if severe side effects occur in any treatment group, that part of the study will be stopped.

Eligibility Criteria

Inclusion Criteria

  • Must sign a consent form to participate.
  • Confirmed diagnosis of prostate cancer through a biopsy.
  • PSA level of 20 ng/mL or less.
  • Gleason score of 7.
  • Cancer stage T1, T2a, T2b, or T2c confirmed by MRI.
  • No signs of cancer spread to other areas.
  • Age 50 or older.
  • Good overall health with a performance status of 0 to 2.
  • Prostate symptom score of 15 or less (medications allowed).
  • Prostate size of 100 grams or less as measured by CT or ultrasound.

Exclusion Criteria

  • Cancer has spread to lymph nodes or other parts of the body.
  • History of another invasive cancer unless cancer-free for at least 5 years.
  • Cancer stage T3 or T4 on MRI.
  • PSA level greater than 20 ng/mL.
  • Gleason score greater than 7.
  • Previous radiation therapy to the pelvic area.
  • Previous surgery for prostate cancer.
  • Previous prostate surgery (TURP).
  • History of Crohn's Disease or Ulcerative Colitis.
  • Significant urinary problems in the past.
  • Severe mental health issues.
  • Prostate size greater than 100 grams.
  • Severe, active health problems.

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