Precision proton beams take aim at High-Risk prostate tumors
NCT ID NCT03624660
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 4 times
Summary
This study tests whether a higher dose of proton radiation, focused on tumors seen on MRI, can better control high-risk prostate cancer. About 100 participants will receive radiation over 8-9 weeks, plus hormone therapy for 18 months. The goal is to lower the chance of cancer returning within 5 years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2018
- Expected to finish
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Sep 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 to 100 years
- 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: * Patient must give study-specific informed consent on an IRB-approved consent prior to any research related procedures or study treatment. * Patient must be at least 18 years at the time of consent. * Adenocarcinoma of the prostate with AJCC Clinical Stage T1to T3b disease with histological evaluation via biopsy or repeat biopsy within 12 months prior to registration. * Patients must undergo a pretreatment diagnostic MRI of the prostate on a 1.5T to 3T Tesla machine within 6 months prior to study registration. * A focal IPT must be visible on MRI within the prostate and/or seminal vesicles and this MRI must be obtained within 6 months of planning CT scan. * A biopsy of the dominant lesion is recommended but not required. If an ultrasound guided sextant biopsy was positive for prostatic adenocarcinoma in the area of the MRI identified intraprostatic lesion, this will be acceptable and another guided biopsy targeting the MRI identified disease will not be necessary. * Patients with at least one of the following high-risk factors: cT3a-T3b OR Gleason 9-10 OR PSA \> 30 OR more than 1 high-risk factors must be present: clinical stage of T3, Gleason score 8-10, or PSA 20 ng/ml or greater. * Hemoglobin must be ≥ 10 g/ml within 4 months prior to registration. * Zubrod performance status must be 0-1 within 4 months prior to registration. * If patient has child-producing potential, they must be willing to use medically acceptable contraception during treatment and must be advised to use it for at least 1 year thereafter. This is not applicable if the patient is not sexually active or has had a vasectomy. * Patients must be able to start treatment within 16 weeks of registration. Exclusion Criteria: * T4 prostate disease on CT, MRI, or physical exam. * Patients unable to undergo MRI of the prostate. * Patients with a greater than 25% change in prostate volume from the pretreatment MRI of the prostate demonstrating the IPT and the treatment planning MRI. Patients in this case must undergo a repeat diagnostic MRI on a 1.5T to 3.0T Tesla machine and an IPT must still be visible. * IPT that is more than 75% of the prostate volume when measured on the CT simulation scan. * Evidence of distant metastasis (M1). * Patients with positive nodes on cross-sectional imaging. * Previous prostate cancer local treatment including prostatectomy, hyperthermia, high intensity focused ultrasound, brachytherapy, external-beam radiation therapy, and/or cryotherapy. * Prior pelvic radiation therapy. * No prior myocardial infarction within the last 6 months, severe congestive heart failure, or end stage renal disease. * Active inflammatory bowel disease (diverticulitis, Crohn's disease, ulcerative colitis) affecting the rectum. * Bilateral hip replacement * Prior intrapelvic surgery. This includes the following: • Bladder surgery * Prior transurethral resection of the prostate (TURP) or laser ablation for benign prostatic hyperplasia (BPH). * Patients receiving continuous and current anticoagulation with warfarin sodium (Coumadin), heparin sodium, clopidogrel bisulfate (Plavix), dabigatran etexilate mesylate (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa), enoxaparin sodium (Lovenox), prasugrel (Effient), ticagrelor (Brilinta), aspirin/er dipyridamole (Aggrenox), or fondaparinux sodium (Arixtra).
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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.
Contacts and locations
Locations
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University of Florida Health Proton Therapy Institute
Jacksonville, Florida, 32206, United States
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Other studies related to the condition(s) this trial covers.
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