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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT00809991
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • hypofractionation — RADIATION
    3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).

Study Details

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.

Key Dates

Start date
Dec 22, 2008
Status verified
Jan 2026
Primary completion
Jul 24, 2024
Completion
Sep 30, 2025

Study Design

Enrollment
91 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Hypofractionated radiation therapy in prostate adenocarcinoma
    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).

Primary Outcome Measure

Number of Participants With Grade 2 or Greater GU and GI Toxicity [ Time Frame: Up to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Johns Hopkins University School of MedicneBaltimoreMaryland21231-

Find similar trials in Baltimore, MD

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
The Johns Hopkins University School of Medicne· Baltimore, MD

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