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One and done? new prostate cancer radiotherapy trial aims to cut treatment to a single session

NCT ID NCT07407608

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study is testing whether a single, high-dose radiotherapy session can safely control prostate cancer in men with intermediate or high-risk disease. About 58 participants will receive one focused radiation dose to the tumor, guided by MRI and imaging. The goal is to see if this shorter treatment causes similar side effects as the standard 5-dose regimen, while still keeping the cancer under control.

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 58 people

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

Started

Jan 2026

Expected to finish

Jul 2034

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

Unfavorable Intermediate and Selected High Risk Prostate Cancer (no cT3b and PSA \> 20 ng/mL allowed), as per NCCN definition

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: * Histologically proven prostate adenocarcinoma; * Intermediate and High risk disease, as per the NCCN definition; * a PI-RADS 3-5 dominant intraprostatic lesion on multiparametric MRI (mpMRI); * N0M0 at staging with standard techniques (Bone Scan and Abdominal CT) or (preferably) PSMA PET-CT; * World Health Organization performance status 0-1; * Life expectancy of \> 5 years, in the opinion of the investigator; * IPSS score must be ≤ 15 (alpha blockers allowed); * Prostate gland volume ≤100 g as estimated by computed tomography (CT), ultrasound, or MRI. Exclusion Criteria: * ≥T3b disease according to the 8th AJCC classification; * PSA\>20 ng/ml; * Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy) or transurethral resection; * Previous radiotherapy to the pelvis; * Presence of a periurethral dominant lesion; * Previous invasive malignancy unless disease free for a minimum of 5 years; * Active Crohn's Disease or Ulcerative Colitis; * Presence of hip prostheses.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma prostate adenocarcinoma prostate cancer

As listed by the trial registrant

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

Prostate cancer Prostate cancer (adenocarcinoma) Prostate cancer non-metastatic

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

    RECRUITING

    Monza, MB, 20900, Italy

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