NCT00809991CompletedPhase 2
Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the Prostate
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 91 (actual)
- First submitted
- 16 Dec 2008
- Start date
- 22 Dec 2008
- Primary completion date
- 24 Jul 2024
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Prostate cancer
- NCT number
- NCT00809991
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 91
- From 22 Dec 2008 to the primary completion date, 24 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Stage T3 to 4 disease
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Johns Hopkins University School of Medicne Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.