Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the Prostate

NCT00809991 | Completed Phase 2 Results DMC FDA Device

• 2 other identifiers: J0859NA_00019393
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a Phase II study evaluating the effectiveness and toxicity of a specific radiation therapy regimen. This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens. The total dose is calculated to be effective for late effects which has been shown to be effective and safe in a large prospective Phase II study. If the hypothesis for the prostate is is true, then this regimen should be at least as effective or more effective for tumor control than the current conventional therapy.

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Grade 2 or Greater GU and GI Toxicity

  Assess the number of participants of grade 2 or greater GU and GI toxicity

  Up to 5 years

• Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions) -IPSS

  The International Prostate Symptom Score (IPSS) is a useful subjective assessment tool for BPH patients; it is a modification of the American Urological Association (AUA) Symptom Index. The questionnaire assesses degree of 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.

  Baseline, 12 -, 24 -, and 36-month follow-up

• The Sexual Health Inventory for Men (SHIM) SCORE - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions)

  The SHIM serves several key functions within clinical and research settings. Its core purpose involves screening for and evaluating the severity of erectile dysfunction. 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, 12 months, 24 months, and 36-month follow-up

• EPIC Sexual Score - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions)

  The EPIC-26 (Expanded Prostate Cancer Index Composite-Short Form) is a validated questionnaire for measuring health related quality of life. Score range from 1 to 100, with higher scores better score.

  Baseline, 12 months, 24 months, and 36-month follow-up

Secondary Outcomes (1)

• Number of Patients With Biochemical Failure Associated With the Hypofractionated Dose Regimen

  Up to 5 years

Study Arms (1)

Hypofractionated radiation therapy in prostate adenocarcinoma

EXPERIMENTAL

Participants with histologically confirmed, locally confined adenocarcinoma of the prostate receive 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).

Radiation: hypofractionation

Interventions

hypofractionation RADIATION

3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).

Hypofractionated radiation therapy in prostate adenocarcinoma

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
• Clinical stages T1a to T2b PSA of less than 10 ng per ml
• Gleason score of less than 3+4=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 to 4 disease
• Gleason 4+3=7 or higher score
• PSA greater than 10 ng per ml
• Clinical or Pathological Lymph node involvement N1
• Evidence of distant metastases M1
• Radical surgery for carcinoma of the prostate
• Previous Chemotherapy or 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

The Johns Hopkins University School of Medicne

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Results Point of Contact

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

dsong2@jh.edu

410-502-5875

Study Officials

• Danny Song, MD

  The Johns Hopkins University School of Medcine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: December 17, 2008
• Study Start: December 22, 2008
• Primary Completion: July 24, 2024
• Study Completion: September 1, 2025
• Last Updated: February 18, 2026
• Results First Posted: February 18, 2026

Record last verified: 2026-01

Locations

US (1)