Radiation and Androgen Ablation for Prostate Cancer

NCT01517451 | Completed Phase 1 Results DMC

• 2 other identifiers: J11157NA_00067963
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Adenocarcinoma of the Prostate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

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

• Overall Survival Rate

  Start of treatment up to 5 years

• 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).

  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

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

Study Arms (1)

Radiation with Androgen Deprivation Therapy (ADT)

EXPERIMENTAL

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; Drug: Androgen Deprivation Therapy (ADT)

Interventions

Radiation Therapy RADIATION

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

Radiation with Androgen Deprivation Therapy (ADT)

Androgen Deprivation Therapy (ADT) DRUG

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

Radiation with Androgen Deprivation Therapy (ADT)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (3)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

MeSH Terms

Interventions

Radiotherapy; Androgen Antagonists

Intervention Hierarchy (Ancestors)

Therapeutics; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Dr. Daniel Song
• Organization: Johns Hopkins Department of Radiation Oncology

dsong2@jh.edu

410-502-5875

Study Officials

• Daniel Song, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2012
• First Posted: January 25, 2012
• Study Start: May 22, 2013
• Primary Completion: February 28, 2024
• Study Completion: December 31, 2025
• Last Updated: February 11, 2026
• Results First Posted: February 11, 2026

Record last verified: 2026-01

Locations

US (3)