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One-Shot radiation for recurrent prostate cancer: game changer or risky bet?

NCT ID NCT06941363

Disease control Sponsor: University of Milano Bicocca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a single, very high dose of radiation (17 Gy) to the prostate area in men whose prostate cancer has come back after surgery. The goal is to see if this precise, one-time treatment can control the cancer while reducing side effects. Fifty men will be enrolled, and researchers will track side effects and quality of life for up to 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
single high-dose radiation therapy (17 Gy) to the prostate bed
What this could lead to
If successful, this could offer a shorter, more precise radiation option for men whose prostate cancer returns after surgery, potentially with fewer side effects.
What could go wrong
This is a small, early-phase study with only 50 participants, so results may not apply to everyone. The high single dose may still cause bladder or bowel side effects.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

May 2033

An estimate. End dates often move.

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

Patients with biochemical relapse following radical prostatectomy

Ages

18 to 90 years

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: * Subjects of male sex ≥ 18 years of age. * Subjects have freely signed the pertinent informed consent before the beginning of the study * Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy) * Detectable post-prostatectomy PSA of ≥ 0.1 - \< 2.0 ng/mL either (1) persistently detectable post-operatively or (2) developing biochemical recurrence after prostatectomy (initially undetectable) * No evidence of N1 and/or M1 disease assessed by PSMA PET-CT within 90 days prior to registration * Negative Magnetic Resonance Imaging (MRI) of the pelvis in case of equivocal evidence of local relapse on PSMA PET-CT * Androgen deprivation therapy (ADT) allowed as per physician's discretion * ECOG performance status of 0-1 * Ability to complete the questionnaires Exclusion Criteria: * N1 and or M1 patients * Macroscopic local relapse at pelvic MRI. * Prior radiation of any kind to the prostate gland or pelvis * Prior brachytherapy * History of inflammatory colitis or other active severe comorbidities * Patients who are on immunosuppressant medication

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer

As listed by the trial registrant

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

Prostate cancer (post prostatectomy)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Radiation Oncology, Fondazione IRCCS San Gerardo dei Tintori (University of Milan Bicocca)

    RECRUITING

    Monza, Italy, 20900, Italy

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