Radiation and Androgen Ablation for Prostate Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT01517451

Patient View

This Phase I/II study assesses the effectiveness and toxicity of combining 7.25 Gy radiation fractions (total 36.25 Gy) with 4 months of androgen deprivation therapy (ADT) in treating prostate cancer. Eligible participants have locally confined adenocarcinoma, meet D'Amico intermediate risk criteria, and choose external beam radiation. Consent is required.

Patient Parameters

Program Overview

A study to see how effective and tolerable radiation therapy along with androgen deprivation therapy is in treating prostate cancer.

Description

This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total.

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed, locally confined adenocarcinoma of the prostate
  • Patient must fit D'Amico intermediate risk criteria by clinical stage (T2b-T2c), PSA (prostatic specific antigen) (10-20 ng/mL), and/or Gleason score (Gleason 7).
  • The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer.
  • Signed study-specific consent form prior to registration

Exclusion Criteria

  • Stage T3-4 disease.
  • Gleason 8 or higher score.
  • PSA > 20 ng/ml.
  • IPSS (International Prostate Symptom Score) > 15
  • Clinical or Pathological Lymph node involvement (N1).
  • Evidence of distant metastases (M1).
  • Radical surgery for carcinoma of the prostate.
  • Previous Chemotherapy, unless intervention was greater than 5 years from beginning treatment for current prostate cancer.
  • Previous pelvic radiation therapy.
  • Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years.
  • History of inflammatory bowel disease.
  • Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.
  • Myocardial infarction or cerebrovascular accident within one year from consultation, or other major vascular risk factor which would prevent a patient from receiving appropriate androgen deprivation therapy.11
  • Liver function tests (LFTs) greater than twice the upper limit of normal.

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