Status:
ACTIVE_NOT_RECRUITING
Radiation and Androgen Ablation for Prostate Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Adenocarcinoma of the Prostate
Eligibility:
MALE
18-100 years
Phase:
PHASE1
PHASE2
Brief Summary
A study to see how effective and tolerable radiation therapy along with androgen deprivation therapy is in treating prostate cancer.
Detailed Description
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 de...
Eligibility Criteria
Inclusion
- Histologically confirmed, locally confined adenocarcinoma of the prostate
- 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
- Stage T3-4 disease.
- 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.
Key Trial Info
Start Date :
May 22 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01517451
Start Date
May 22 2013
End Date
December 1 2026
Last Update
June 7 2024
Active Locations (3)
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1
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
2
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
3
Suburban Hospital
Bethesda, Maryland, United States, 20814