Status:
ACTIVE_NOT_RECRUITING
Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the Prostate
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Prostate Cancer
Eligibility:
MALE
18-100 years
Phase:
PHASE2
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...
Detailed Description
Radiation therapy is an effective and frequently utilized modality for the treatment of clinically localized prostate cancer. Traditionally, external beam radiation has been delivered in a fractionate...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 22 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00809991
Start Date
December 22 2008
End Date
September 1 2025
Last Update
April 17 2024
Active Locations (1)
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1
The Johns Hopkins University School of Medicne
Baltimore, Maryland, United States, 21231