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Proton therapy cuts prostate cancer treatment to two weeks

NCT ID NCT03159676

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

150 people

The number who actually took part.

Started

May 2017

Finished

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

Male participants only

Show 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

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.