Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
105 participants
INTERVENTIONAL
2013-05-22
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Radiation with Androgen Deprivation Therapy (ADT)
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 Therapy
7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions)
Androgen Deprivation Therapy (ADT)
Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.
Interventions
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Radiation Therapy
7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions)
Androgen Deprivation Therapy (ADT)
Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
100 Years
MALE
No
Sponsors
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Daniel Song, M.D.
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Suburban Hospital
Bethesda, Maryland, United States
Countries
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Other Identifiers
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NA_00067963
Identifier Type: OTHER
Identifier Source: secondary_id
J11157
Identifier Type: -
Identifier Source: org_study_id
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