Double-Dose precision: new combo radiation aims to shrink prostate tumors faster
NCT ID NCT04945642
First seen Jul 09, 2026 · Last updated Aug 21, 2026 · Updated 3 times
Summary
This trial tests a combination of two advanced radiation techniques for men with intermediate- to high-risk prostate cancer that has not spread beyond the prostate. One technique, high-dose rate brachytherapy, places radioactive material directly into the tumor. The other, stereotactic body radiotherapy, delivers highly focused radiation from outside the body. The goal is to see if this combination can control the cancer while reducing side effects and treatment time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- High-dose rate brachytherapy and stereotactic body radiotherapy
- What this could lead to
- If successful, this approach could offer a shorter, more precise radiation treatment for prostate cancer with fewer side effects.
- What could go wrong
- This is a phase 2 trial with a small number of participants, so results may not apply to all patients. Radiation can still cause urinary or bowel side effects.
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 52 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2021
- Expected to finish
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Jul 2028
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 Criteria: * Ability to understand a written informed consent document, and the willingness to sign it * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration * Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA \> 10, and/or Gleason score \>= 7 * No evidence of disease beyond the prostate and/or seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis) * Prostate size =\< 60cc * International Prognostic Scoring System (IPSS) score =\< 15 * Able to safely receive moderate sedation or general anesthesia Exclusion Criteria: * Patients with neuroendocrine or small cell carcinoma of the prostate * Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years * Regional lymph node involvement * Evidence of distant metastases * Previous radical surgery (prostatectomy) or cryosurgery or high-intensity focused ultrasound for prostate cancer * Previous pelvic irradiation or prostate brachytherapy * Previous or concurrent cytotoxic chemotherapy for prostate cancer * Patients with history of inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), high predisposition for radio-toxicity compared to general population (i.e., ataxia telangiectasia), or at risk for major bowel surgery * Transurethral resection of the prostate (TURP) procedure within 6 months of radiation treatment
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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
1 site. 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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University of California at Los Angeles / Jonsson Comprehensive Cancer Center
RECRUITINGLos Angeles, California, 90095, United States
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Other studies related to the condition(s) this trial covers.
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- Can MRI-Guided radiation zero in on prostate tumors with fewer side effects?
- Can 3D imaging make prostate radiation more precise and worth the cost?
- Can surgery boost control of spread prostate cancer?
- Can a better scan sharpen radiation for prostate cancer?