NCT01517451CompletedPhase 1/2
Radiation and Androgen Ablation for Prostate Cancer
Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
A study to see how effective and tolerable radiation therapy along with androgen deprivation therapy is in treating prostate cancer.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 20 Jan 2012
- Start date
- 22 May 2013
- Primary completion date
- 28 Feb 2024
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Prostate cancer
- NCT number
- NCT01517451
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 45
- From 22 May 2013 to the primary completion date, 28 Feb 2024
- 3 sites 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, 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.
- 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
Other illness
- Stage T3-4 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 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).
- Liver function tests (LFTs) greater than twice the upper limit of normal.
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Suburban Hospital Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| Sibley Memorial Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.