New radiation boost aims to improve prostate cancer control
NCT ID NCT02016248
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether adding a short, high-dose radiation boost to standard radiation therapy can safely improve treatment for men with unfavorable localized prostate cancer. The boost is delivered non-invasively using stereotactic body radiotherapy (SBRT), similar to a needle-free version of brachytherapy. Researchers will track cancer control, side effects, and quality of life in 150 participants over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Stereotactic body radiotherapy (SBRT) boost
- What this could lead to
- If successful, this approach could offer a more effective, non-invasive way to treat unfavorable localized prostate cancer, potentially reducing the chance of cancer returning.
- What could go wrong
- This is a single-arm study with no comparison group, so it's unclear if the SBRT boost is better than standard treatment. Side effects like urinary or bowel problems are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2012
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Long Beach Memorial Medical Center
RECRUITINGLong Beach, California, 90806, United States
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Orange Coast Memorial Medical Center
RECRUITINGFountain Valley, California, 92708, United States
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Saddleback Memorial Medical Center
RECRUITINGLaguna Hills, California, 92653, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?