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New radiation approach shows promise for prostate cancer control

NCT ID NCT02761889

Disease control Sponsor: Fundacao Champalimaud Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new way to give radiation therapy for prostate cancer. It used very precise, high-dose radiation over just five days. The goal was to control the cancer while reducing side effects on the bladder and bowel. 444 men with localized prostate cancer took part, and researchers tracked their health and quality of life for five years.

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Study facts

What this study's own registry entry says, in plain language.

Phase

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

444 people

The number who actually took part.

Started

May 2013

Finished

Dec 2025

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.

Ages

40 years and older

Sex

Male participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Participants must meet all of the following criteria: * Signed study-specific informed consent. * Histologic confirmation of adenocarcinoma of the prostate by biopsy. * Localized low-risk, intermediate-risk, or selected high-risk adenocarcinoma of the prostate. Selected high-risk disease is limited to patients with no MRI evidence of radiographic T3/T4 disease and no radiographic regional or distant metastases. * No direct evidence of regional or distant metastases after appropriate staging studies. * Previous or concomitant hormonal therapy is allowed but not required. - Previous hormonal therapy must not have been given for more than 6 months before protocol therapy. * Age ≥40 years. * Performance status 0-2. * IPSS score ≤20; alpha blockers are allowed. * CT- or ultrasound-based prostate volume estimate ≤150 grams. Participants meeting any of the following criteria are ineligible: * Metastatic prostate cancer on imaging studies. * MRI evidence of radiographic T3 or T4 disease. * Previous pelvic radiotherapy. * Previous surgery for prostate cancer. * Previous hormonal therapy given for more than 6 months before protocol therapy. * History of Crohn's disease or ulcerative colitis. * Significant obstructive urinary symptoms, defined as IPSS \>20. * Significant psychiatric illness that would interfere with protocol participation. * Severe active comorbidity that, in the investigator's judgment, would preclude safe protocol therapy or required follow-up.

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adenocarcinoma of the prostate

Contacts and locations

Locations

  • Champalimaud Foundation

    Lisbon, 1400-038, Portugal

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