Proton therapy cuts prostate cancer treatment to two weeks
NCT ID NCT03159676
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a shorter course of proton radiation (5 treatments over 2 weeks) for men with localized prostate cancer, compared to the usual 8 weeks. The goal was to see if this approach maintains quality of life and controls the cancer. 150 men with low- to intermediate-risk prostate cancer took part. The study focused on tracking side effects and cancer recurrence.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Proton beam radiation
- What this could lead to
- If successful, this could offer a more convenient, shorter radiation treatment option for prostate cancer with fewer side effects.
- What could go wrong
- This is a completed early-phase study with 150 participants, so results may not apply to all patients. There is still a risk of side effects like urinary or bowel issues.
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.
- Participants
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150 people
The number who actually took part.
- Started
-
May 2017
- Finished
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Dec 2024
- Lead sponsor
-
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.
Who is studied
Adult male patients with prostate cancer.
- Ages
-
18 years and older
- Sex
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Male participants only
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: * Male, age ≥ 18 years. * Histological confirmation of adenocarcinoma of prostatic origin. * AJCC 7th edition clinical T1b-fdiabetes mellitus T2b. * AJCC clinical staging rules do not include findings from biopsy or imaging. * Gleason score ≤7 (International Society of Urological Pathologists grades 1-3). * Serum prostate-specific antigen ≤20 ng/mL. * Prostate-specific antigen \<10 ng/mL, if dutasteride within last 90 days or finasteride within last 30 days. * Zubrod performance score 0-1. * Prostate volume \<75-cc, determined by ultrasound, computed tomography or magnetic resonance imaging (modality with lesser volume is acceptable). * If neoadjuvant-concurrent androgen suppression is used, the prostate volume after the start of androgen suppression may be used. * American Urological Association voiding symptom index ≤15. * Ability to complete questionnaire(s) by themselves or with assistance. * Participation in a patient-reported outcomes survey program, inclusive of the Expanded Prostate Index Composite and CTCAE instruments. * Ability to provide informed written consent. Exclusion Criteria: * Radiological- or pathologically-confirmed seminal vesicle invasion, lymph node involvement, or distant metastatic disease. * Radiological- or biopsy-confirmed extraprostatic tumor extension without AJCC 7th edition clinical T3a classification remain eligible. * Prior or anticipated external radiotherapy or brachytherapy, transurethral resection of the prostate, prostatic cryoablation/focused ultrasound/laser therapy, prostatectomy, or prostatic enucleation. * Prior bilateral orchiectomy, planned long-term (\>6 months duration) androgen suppression or peripheral androgen blockade, or chemotherapy or immunotherapy for prostate cancer. * Prior hemi- or total hip arthroplasty. * Diabetes mellitus associated with vascular ulcers or wound healing problems, ulcerative colitis, connective tissue disorder, or chronic (≥120 days) warfarin or clotting factor inhibitor (e.g., rivaroxaban) use planned. * Co-morbid severe concurrent disease which, in the judgment of the investigator, would result in life expectancy \<5 years. * Patients with a left cardiac ventricular assist device are ineligible. * Patients with an implanted medical electronic device (e.g., cardiac pacemaker) remain eligible if device monitoring complies with standard of practice (e.g., Cardiology and Medical Physics evaluation, function checks and during-treatment monitoring). * Immunocompromised due to HIV positive state. * Medical or psychiatric conditions that preclude informed decision-making or adherence. * Prior registration to an Institutional Review Board-approved therapeutic research study that includes proton beam therapy or photon-based radiotherapy (e.g., randomization to proton beam therapy vs. photon-based radiotherapy). * Registration to a non-therapeutic (e.g., biomarker, medical physics) only research study is not an exclusion. * Inability to start radiation per protocol.
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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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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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Other studies related to the condition(s) this trial covers.
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- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer