Radiation and Androgen Ablation for Prostate Cancer

Completed · Phase 1/Phase 2

Conditions studied: Adenocarcinoma of the Prostate

In brief

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

Key facts

Study ID

NCT01517451

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

45

Starts

2013-05-22

Expected to finish

2025-12-31

Last updated by the study team

2026-02-11

Who can join

Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
• The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• Suburban Hospital — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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