Radiation and Androgen Ablation for Prostate Cancer

Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate

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

Study Overview

• Status: Completed
• Conditions: Adenocarcinoma of the Prostate
• Intervention / Treatment: Radiation: Radiation Therapy; Drug: Androgen Deprivation Therapy (ADT)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20016
      • Sibley Memorial Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Bethesda, Maryland, United States, 20814
      • Suburban Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Radiation with Androgen Deprivation Therapy (ADT); 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, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens.

Radiation: Radiation Therapy; 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions); Drug: Androgen Deprivation Therapy (ADT); Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical Failure Free-rate (BFFR) Associated With the Combined Hypofractionated Dose Regimen and Androgen Deprivation Therapy (ADT).	To assess 5-year biochemical failure free rate (BFFR) associated with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently. BFFR is defined as binary indicator whether PSA has increased by 2 ng/ml or more above the nadir PSA any time before the end of 5 years as the number of events.	From consent up to 5 years post treatment completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity as Assessed as Incidence of Grade 3 or Greater Gastrointestinal (GI) and Genitourinary (GU) Adverse Events	Incidence of grade 3 or greater GU (genitourinary) and GI (gastrointestinal) toxicity with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.	Consent to up to 5 years of follow-up or biochemical failure.
Overall Survival Rate	Assess clinical control rate by measuring the Overall Survival (OS) which is defined as the percentage of participants who completed the study that lived from time of treatment until death from any cause.	Start of treatment up to 5 years
Number of Patients Who Completed Blood Collection of Whole Blood for Future Research	Biomarker studies. Number of patients who completed blood collection of whole blood for future research.	Up to 2 years post treatment
Self-reported Patient Quality of Life Data Using the International Prostate Symptom Score (IPSS).	The International Prostate Symptom Score (IPSS) is a useful subjective assessment tool for Benign prostatic hyperplasia (BPH) patients; it is a modification of the American Urological Association (AUA) Symptom Index. The questionnaire assesses degree of Lower Urinary Tract Symptoms (LUTS) and quality of life. Patients can fill out the IPSS form before examinations, but minimal interference from health care providers must be ensured. Total score range 0-35; A score of 7 or less is mildly symptomatic, 8 to 19 is moderately symptomatic, and 20 to 35 is severely symptomatic.	Measured at baseline and at 3, 12, 24 and 36 months post treatment
Patient Reported Sexual Health Inventory for Men (SHIM), a Self-reported Quality of Life Assessment	The SHIM serves several key functions within clinical and research settings. Its core purpose involves screening for and evaluating the severity of erectile dysfunction (ED). Total score range 5 to 25; higher scores indicate better erectile function. A total score of 21 or less indicates erectile dysfunction. 22-25: No erectile dysfunction, 17-21: Mild ED, 12-16: Mild-to-moderate ED, 8-11: Moderate ED, 5-7: Severe ED.	Baseline and at 3,12, 24 and 36 months follow-up
The Expanded Prostate Cancer Index Composite 26 (EPIC). Self-reported Quality of Life Assessment of Sexual Health	The EPIC-26 (Expanded Prostate Cancer Index Composite-Short Form) is a validated questionnaire for measuring sexual health related quality of life. Scores range from 1 to 100, with higher scores being better score.	3,12, 24 and 36 months follow-up

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Investigators: Principal Investigator: Daniel Song, M.D., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2013
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: January 20, 2012
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (Estimated): January 25, 2012

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Adenocarcinoma; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Therapeutics; Pharmacologic Actions; Chemical Actions and Uses; Androgen Antagonists; Radiotherapy
• Other Study ID Numbers: J11157; NA_00067963 (Other Identifier: JHMIRB)