NCT04552509Active, not recruiting
TRUEBEAM Stereotactic Body Radiotherapy for Localized Prostate Cancer
Prospective Evaluation of TRUEBEAM Stereotactic Body Radiotherapy for Localized Prostate Cancer: Risk Stratified MonoTherapy Versus RADIOSURGERY Boost
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
The purpose of this study is to determine the effects of TrueBeam stereotactic body radiosurgery in patients with prostate cancer. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. The purpose of this evaluation is to see if this treatment will help patients with your condition and to evaluate the effect of this treatment on your quality of life over time. Radiosurgery is a non-invasive treatment technique used to treat tumors. Despite the word "surgery" in the name, the technology does not remove the tumor with a surgical knife. Instead, a focused, high-intensity beam of radiation targets the tumor, while minimizing dose to surrounding normal healthy tissue.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 167 (estimated)
- First submitted
- 3 Sept 2020
- Start date
- 5 Jun 2018
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Linda Chan, MD
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT04552509
What you commit to
- Study type: Interventional
- Planned participants: 167
- From 5 Jun 2018 to the primary completion date, 1 Dec 2026
- 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
- Prior prostatectomy or cryotherapy of the prostate
- Prior radiotherapy to the prostate or lower pelvis
Other
- Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
Who the study is looking for
- 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 6th Edition)
- M-stage determined by physical exam, CT, MRI, or Bone Scan. Bone scan not required for Monotherapy Risk Group patients unless clinical findings suggest possible osseous metastases. Bone Scan and contrast CT of the abdomen should be done patients in the Boost Risk Group patients.
- Prostate volume: ≤ 100 cc (recommended not required)
- Determined using: volume = π/6 x length x height x width
- Measurement from CT or ultrasound ≤90 days prior to registration.
- ECOG performance status 0-1
- Completion of patient questionnaires in section 4.7.
- Consent signed
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 |
|---|---|---|---|
| MemorialCare Saddleback Medical Center Coordinator of this site? Confirm its status | Laguna Hills | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.