Study on Radiation and Hormone Therapy for Prostate Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT01517451

Provider View

This clinical trial is testing how well a combination of radiation therapy and hormone therapy works in treating prostate cancer, and how tolerable it is for patients.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness and safety of combining radiation therapy with hormone therapy (androgen deprivation therapy) for prostate cancer. The treatment involves receiving radiation in five sessions, every other day, along with hormone therapy for a total of four months.

Description

This clinical trial is designed to test a treatment plan that combines radiation therapy with hormone therapy for prostate cancer. The radiation therapy will be given in five sessions, with each session spaced every other day, reaching a total dose of 36.25 Gy. Alongside this, patients will receive hormone therapy, known as androgen deprivation therapy (ADT), for a period of four months. The study will assess how effective this combined treatment is in controlling prostate cancer and how well patients tolerate it.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer that is confirmed to be localized and not spread beyond the prostate.
  • Fits specific risk criteria based on clinical stage, PSA levels, and Gleason score.
  • Has chosen external beam radiation as the treatment option for prostate cancer.
  • Has signed a consent form specific to this study before starting.

Exclusion Criteria

  • Prostate cancer that is more advanced (Stage T3-4).
  • Higher Gleason score of 8 or more.
  • PSA levels greater than 20 ng/ml.
  • High score on a prostate symptom questionnaire (IPSS > 15).
  • Cancer has spread to lymph nodes or other parts of the body.
  • Previous major surgery for prostate cancer.
  • Previous chemotherapy unless it was over 5 years ago.
  • Previous radiation therapy to the pelvic area.
  • Other cancers unless they have been disease-free for at least 5 years.
  • History of inflammatory bowel disease.
  • Major medical or psychiatric conditions that could interfere with treatment or follow-up.
  • Recent heart attack or stroke within the past year, or other major vascular risk factors.
  • Abnormal liver function tests that are more than twice the normal limit.

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