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Completed

NCT Number: NCT01517451

Radiation and Androgen Ablation for Prostate Cancer

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

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Key information

Conditions

Adenocarcinoma of the Prostate

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sibley Memorial Hospital, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

radiation therapy

Radiation

7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions)

Androgen deprivation therapy (ADT)

Drug

Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.

Primary outcomes

  1. Biochemical Failure Free-rate (BFFR) Associated With the Combined Hypofractionated Dose Regimen and Androgen Deprivation Therapy (ADT).

    Time frame: From consent up to 5 years post treatment completion

    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.

Secondary outcomes

  1. Toxicity as Assessed as Incidence of Grade 3 or Greater Gastrointestinal (GI) and Genitourinary (GU) Adverse Events

    Time frame: Consent to up to 5 years of follow-up or biochemical failure.

    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.

  2. Overall Survival Rate

    Time frame: Start of treatment up to 5 years

    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.

  3. Number of Patients Who Completed Blood Collection of Whole Blood for Future Research

    Time frame: Up to 2 years post treatment

    Biomarker studies. Number of patients who completed blood collection of whole blood for future research.

  4. Self-reported Patient Quality of Life Data Using the International Prostate Symptom Score (IPSS).

    Time frame: Measured at baseline and at 3, 12, 24 and 36 months post treatment

    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.

  5. Patient Reported Sexual Health Inventory for Men (SHIM), a Self-reported Quality of Life Assessment

    Time frame: Baseline and at 3,12, 24 and 36 months follow-up

    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.

  6. The Expanded Prostate Cancer Index Composite 26 (EPIC). Self-reported Quality of Life Assessment of Sexual Health

    Time frame: 3,12, 24 and 36 months follow-up

    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.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2024
Study completion
2025
First posted
Jan 25, 2012
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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