Proton beam aims to zap prostate cancer return with fewer side effects
NCT ID NCT00969111
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests proton radiation therapy for men with prostate cancer that has returned or is at risk of returning after prostate removal surgery. Researchers want to see if this precise type of radiation can control the cancer while causing fewer side effects than standard radiation. About 70 men will receive different doses of proton therapy depending on their risk level.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- proton radiation therapy
- What this could lead to
- If successful, this could offer a more precise radiation option for prostate cancer patients after surgery, potentially reducing side effects while controlling the disease.
- What could go wrong
- This is a small, early-phase study with only 70 participants, so results may not apply to everyone. Side effects like bowel or bladder issues are still 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 70 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Aug 2009
- Expected to finish
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Aug 2050
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
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: * Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy. * Maximum PSA value of 20 ng/ml. Exclusion Criteria: * Evidence of distant metastasis (M1). * Prior systemic chemotherapy for any reason. * Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment. * Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed). * Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years. * Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
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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
6 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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Inova Schar Cancer Institute
RECRUITINGFairfax, Virginia, 22031, United States
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McLaren Proton Therapy Center
RECRUITINGFlint, Michigan, 48532, United States
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Mercy David C. Pratt Cancer Center
RECRUITINGSt Louis, Missouri, 63141, United States
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Northwestern Medicine Chicago Proton Center
RECRUITINGWarrenville, Illinois, 60555, United States
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Proton Center of Arkansas
RECRUITINGLittle Rock, Arkansas, 72205, United States
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University of Florida Proton Therapy Institute
RECRUITINGJacksonville, Florida, 32206, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radioactive missile aims at prostate cancer that spread
- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains