NCT02016248Recruiting
SBRT Boost for Unfavorable Prostate Cancer'
Prospective Evaluation of Stereotactic Body Radiotherapy Boost for Unfavorable Localized Prostate Cancer
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
The purpose of this study is to find out whether giving a short course of focused radiation called an SBRT "boost" is a safe and effective way to treat prostate cancer. This boost delivers a high dose of radiation to the prostate in a non-invasive way, similar to what is done with high dose rate (HDR) brachytherapy but without using needles. The study looks at how well this treatment controls the cancer, what side effects it may cause, and how it affects patients' quality of life over time.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 4 Dec 2012
- Start date
- 1 Jun 2012
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- MemorialCare Health System
- Diseases
- Prostate cancer
- NCT number
- NCT02016248
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 1 Jun 2012 to the primary completion date, 30 Jun 2028
- 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.
Criteria the registry did not label
- Inclusion
- Histologically proven prostate adenocarcinoma
- Biopsy within 12 months of date of registration required except for patients who already meet criteria for enrollment in the high risk arm of the protocol. For these patients, repeat biopsy will be at the discretion of the treating physician. In general, repeat biopsy is recommended for these patients, but is not required if it will not affect the treating physician's management decisions in regards to the care of the patient.
- Clinical Stage I-IV, MX-M0 (AJCC VERSION 9)
- M-stage determined by physical exam, CT, MRI, bone scan, PSMA PET/CT, or biopsy.
- Prostate volume: ≤ 100 cc (recommended not required)
- Determined using: volume = π/6 x length x height x width
- Measurement from CT, MRI or ultrasound ≤ 90 days prior to registration.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- No prior prostatectomy or cryotherapy of the prostate
- No prior radiotherapy to the prostate or lower pelvis
- No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
- Completion of patient questionnaires in section 3.7.
- Consent signed
- Exclusion
- No prior prostatectomy or cryotherapy of the prostate
- No prior radiotherapy to the prostate or lower pelvis
- No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
Age in the registry: 18 years to - · 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 |
|---|---|---|---|
| Orange Coast Memorial Medical Center Coordinator of this site? Confirm its status | Fountain Valley | United States | Recruiting |
| Saddleback Memorial Medical Center Coordinator of this site? Confirm its status | Laguna Hills | United States | Recruiting |
| Long Beach Memorial Medical Center Coordinator of this site? Confirm its status | Long Beach | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.