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Radiation boost may extend Drug-Free time in prostate cancer recurrence

NCT ID NCT07782112

Disease control Sponsor: Ente Ospedaliero Cantonale, Bellinzona 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This trial tests whether adding targeted radiation to standard hormone therapy can help men with recurring prostate cancer stay off cancer drugs longer. Men with a rising PSA and 1 to 5 metastases will receive either hormone therapy alone or hormone therapy plus radiation to the metastases and possibly the pelvic area. The goal is to see if radiation leads to a deeper PSA drop and delays the need to restart treatment, while also checking its impact on quality of life.

What this could mean

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

Active substance
enzalutamide plus androgen-deprivation therapy, with or without metastasis-directed radiotherapy and/or pelvic radiotherapy
What this could lead to
If adding radiation works, men with recurring prostate cancer might enjoy longer drug-free periods while keeping the cancer in check, improving quality of life.
What could go wrong
The trial is still in progress, so results are not yet known. Radiation may not extend the drug-free period, and side effects from added treatment could affect quality of life.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 140 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

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.

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: * Histologically proven initial diagnosis of adenocarcinoma of the prostate * Rising PSA after local therapy as defined by PSA ≥ 0.2 ng/mL after RP +/- adjuvant/salvage prostate bed RT and at least 2 ng/mL above nadir for primary RT, with a PSADT ≤ 9 months * Serum Testosterone ≥ 150 ng/dl (6.9343 nM/L) * On PSMA PET/CT restaging presence of: 1 to 5 distant metastases that are amenable to MDT ± N1 patients (no limit in the number of nodes) * ECOG performance status 0 - 2 * Age \> or =18 years * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial * Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations Exclusion Criteria: * More than 5 distant PSMA positive metastases and/or brain or leptomeningeal metastases. * Prostate recurrence (positive PSMA disease) after primary prostate irradiation * Prostate bed recurrence (positive PSMA disease) after salvage/adjuvant irradiation * Pelvic nodal recurrence (positive PSMA disease) after primary WPRT irradiation * Contraindications to pelvic RT and/or MDT * Prior evidence of distant metastatic disease * Contraindications to ADT * Contraindication for treatment with enzalutamide * Prior hormonal therapy (Neoadjuvant/adjuvant therapy to treat PCa ≤ 36 months in duration and ≥ 9 months before randomization is allowed) * Previous treatment with cytotoxic agent for PCa * Any active malignancies (i.e., progressing or requiring any treatment in the previous 36 months) other than prostate cancer (except non-muscle invasive bladder cancer; non-melanomatous skin cancer or a malignancy that is considered cured with minimal risk of recurrence

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate cancer prostate neoplasm

As listed by the trial registrant

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

Biochemical recurrence Oligometastatic prostate cancer Prostatic neoplasms

How to take part

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

  1. The places running it

    19 sites in 3 countries. 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

  • AZ Groeninge

    Kortrijk, Belgium

  • AZ Sint-Jan

    Bruges, Belgium

  • AZ Sint-Maarten Mechelen

    Mechelen, Belgium

  • AZorg Aalst

    Aalst, Belgium

  • CHU de Saint-Etienne

    Saint-Etienne, France

  • Centre Oscar Lambret

    Lille, France

  • IOSI-EOC

    Bellinzona, 6500, Switzerland

  • Inselspital

    Bern, Switzerland

  • Institut Bergonié

    Bordeaux, France

  • Institut Bordet - HUB Brussel

    Brussels, Belgium

  • Institut Gustave Roussy

    Villejuif, France

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, France

  • Iridium Netwerk

    Antwerp, Belgium

  • Jessa ziekenhuis

    Hasselt, Belgium

  • KSA

    Aarau, Switzerland

  • KSGR

    Chur, Switzerland

  • KSW

    Winterthur, Switzerland

  • Spital Thurgau

    Münsterlingen, Switzerland

  • USZ

    Zurich, Switzerland

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