Study on Hypo-fractionated Radiation Therapy With or Without Hormone Therapy for Intermediate Risk Prostate Cancer

Sponsor: Proton Collaborative Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01492972

Provider View

This clinical trial is comparing two treatment methods for men with intermediate risk prostate cancer: proton beam radiation therapy alone and proton therapy combined with hormone therapy. The study aims to understand the benefits and effects of adding hormone therapy to radiation treatment.

Patient Parameters

Program Overview

The purpose of this study is to compare the effects of two treatment methods for men with intermediate risk prostate cancer. One method uses proton beam radiation therapy alone, while the other combines this radiation therapy with hormone therapy (androgen suppression). Researchers want to find out if adding hormone therapy provides any additional benefits in controlling prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer at intermediate risk for recurrence, confirmed by a biopsy within the past year.
  • Cancer stage between T1 and T2c, with no spread to lymph nodes or other parts of the body.
  • Gleason score between 2 and 7 from a prostate biopsy.
  • PSA level of 20 ng/ml or lower, measured within 90 days before joining the study.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Must sign a consent form to participate in the study.
  • Must complete all required tests before starting the study.
  • Must be able to start treatment within 56 days of joining the study.
  • Must be at least 18 years old.
  • For those receiving brachytherapy, a urinary symptom score of 21 or lower, or 17 or lower if on medication for urination.
  • Prostate size must be less than 55cc before starting hormone therapy.

Exclusion Criteria

  • Enlarged pelvic lymph nodes unless tested and found not to have cancer.
  • Previous prostate cancer surgeries like prostate removal or cryosurgery.
  • Previous radiation treatment for prostate cancer.
  • Previous hormone therapy for prostate cancer.
  • Active bowel diseases like rectal diverticulitis or Crohn's disease affecting the rectum.
  • Previous chemotherapy for prostate cancer.
  • History of urethral stricture needing treatment.
  • Current use of blood thinners unless they can be stopped if needed.
  • Major medical, mental health, or addiction issues that could interfere with treatment or follow-up.
  • Other cancers within the past 5 years with less than a 50% chance of 5-year survival, except for certain skin cancers.
  • Heart attack within the last 6 months.

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