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One-Time radiation blast shows promise for prostate cancer

NCT ID NCT02104362

Disease control Sponsor: Centre Antoine Lacassagne Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested a single, high-dose radiation treatment for men with low-risk or low intermediate-risk prostate cancer. The goal was to see how well the body tolerates this one-time treatment by tracking side effects in the bladder and digestive system within the first 6 months. The approach uses a special gel to protect the rectum during the procedure.

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

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

35 people

The number who actually took part.

Started

Feb 2014

Finished

Jun 2021

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

18 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.

Inclusion Criteria: * Patients suffering from histologically-proven adenocarcinoma-type prostate cancer: * with low risk of biochemical recurrence * with a low intermediate risk of biochemical recurrence (maximum of 1 intermediate risk factor)\* * stage T1c, T2a, T2b * Gleason score 6 (3+3) or 7 (3+4) with at most 3 positive biopsies * PSA \< 15 ng/ml * Age ≥ 18 years * Karnofsky index ≥ 70% * Life expectancy ≥ 10 years * No contraindication to injection of hyaluronic acid in the prostate-rectal interspace * Patient aware of the information leaflet and having signed the informed consent form * Patient covered by medical insurance Exclusion Criteria: * Stage ≥ T2c * Gleason score 7 (4+3) or ≥ 8 * PSA \> 15 ng/ml * Presence of the following anatomico-pathological criteria: * Involvement of the nerve fibers * Peri-tumoral vascular embolisms * Capsule involvement * Number of positive biopsies ≥ 50% * 100% positive biopsies in a lobe * Involvement of the seminal vesicle * Prostate volume ≥60 cc * Large prostatic transurethral resection and/or dating from less than 6 months * Poor urinary function in the absence of alpha-blockers * IPSS score \> 15 * Post-mictional residue \> 50 cc * Flow rate with Qmax \< 12 ml/s * Remote metastasis * Neoadjuvant anti-androgenic treatment * Prior treatment with pelvic irradiation and/or chemotherapy * Active infection or other underlying severe pathology likely to prevent the patient from receiving treatment * History of cancer other than basocellular cutaneous cancer or other form of cancer in complete remission for more than 5 years * Evolving psychiatric disorder * Vulnerable persons as defined by article L1121-5 to -8

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

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

Prostate cancer

Contacts and locations

Locations

  • Centre Antoine Lacassagne

    Nice, 06000, France

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