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Precision radiotherapy may buy time for men with spreading prostate cancer

NCT ID NCT07691697

Disease control Sponsor: Affidea Nu-med Center of Oncological DIagnostics and Therapy 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This study investigates whether precisely targeted radiotherapy can delay the need for stronger drugs in men with prostate cancer that has started to grow in a few new spots while on systemic therapy. Participants have metastatic hormone-sensitive or castration-resistant prostate cancer and develop up to five new or growing lesions detected by PSMA PET imaging. The treatment, called progression-directed radiotherapy, uses techniques like stereotactic body radiotherapy or brachytherapy to target only those active lesions. The goal is to see if this approach can postpone switching to a new line of systemic therapy and maintain control of the disease.

What this could mean

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

Active substance
Progression-directed radiotherapy (stereotactic body radiotherapy, brachytherapy, or external beam radiotherapy)
What this could lead to
If successful, this approach could help men with prostate cancer delay switching to more aggressive systemic treatments, preserving quality of life.
What could go wrong
This is an observational registry, not a controlled trial, so results may be influenced by patient selection. Radiotherapy carries risks like fatigue, urinary or bowel irritation, and may not prevent further progression.

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 1,000 people

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

Started

Jun 2026

Expected to finish

Dec 2031

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

Adults with histologically confirmed prostate adenocarcinoma and metastatic hormone-sensitive or metastatic castration-resistant disease receiving active systemic therapy at participating centers. Before amendment activation, eligible metastatic progression is limited to 1-5 lesions. After site-specific amendment activation, prospective candidates have 1-10 qualifying progressing metastatic lesions on baseline PSMA PET and undergo formal review to determine whether every metastatic and local progressing site can be treated with comprehensive PDRT. Otherwise, eligible local-only cases form a separate descriptive stratum.

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.

* Age 18 years or older. * Histologically confirmed prostate adenocarcinoma. * Metastatic hormone-sensitive or metastatic castration-resistant prostate cancer. * Active systemic anticancer therapy at the qualifying limited-progression assessment. * Qualifying baseline PSMA PET/CT or PSMA PET/MRI with review of relevant anatomical imaging. * Metachronous, repeat, or induced oligoprogression or limited progression according to the protocol framework. * Retrospective cases treated before June 26, 2026: 1-5 qualifying progressing metastatic lesions. * Prospective cases enrolled before the site-specific amendment effective date: 1-5 qualifying progressing metastatic lesions. * Prospective cases enrolled after the site-specific amendment effective date: 1-10 qualifying progressing metastatic lesions, prespecified as 1-5 or 6-10. * Intraprostatic or prostate-bed progressing foci are recorded separately from the metastatic-lesion count and must also be technically amenable to comprehensive PDRT. * Every qualifying metastatic and local progressing site is judged technically amenable to comprehensive definitive-intent PDRT before prospective analytic-cohort enrollment. * For post-amendment prospective enrollment, qualifying PSMA PET performed within 60 days before enrollment and index PDRT planned to begin within 60 days after the scan. * Availability of the qualifying PET date, systemic-therapy dates, locked metastatic-lesion count, separate local-site count, lesion map, and eligibility decision. For retrospective inclusion, PDRT exposure and at least one outcome or censoring time must also be determinable. Exclusion Criteria * Limited progression defined only by conventional CT, MRI, or bone scintigraphy without a qualifying PSMA PET examination. * More than five qualifying progressing metastatic lesions for retrospective or pre-amendment inclusion. * More than 10 qualifying progressing metastatic lesions after amendment activation. * Diffuse, non-enumerable, or rapidly progressive disease that is not considered suitable for comprehensive lesion-directed radiotherapy. * Any known active metastatic or local progressing site that cannot be included in the comprehensive PDRT plan. * Clinical deterioration or an urgent systemic-treatment indication that makes comprehensive PDRT inappropriate or unsafe. * Radiotherapy delivered solely with palliative symptom-control intent rather than definitive progression-directed local-control intent. * For prospective participation, inability to complete the approved consent process. * For retrospective cases, missing baseline imaging or core dates such that metastatic burden, PDRT exposure, or at least one outcome or censoring time cannot be determined reliably.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

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

Metastatic prostate cancer Oligoprogressive prostate cancer

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

  • Affidea Nu-Med Cancer Diagnostics and Therapy Center

    RECRUITING

    Zamość, Lublin Voivodeship, 22-400, Poland

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