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Radiation plus hormone therapy may slow resistant prostate cancer

NCT ID NCT07717268

Disease control Sponsor: Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study tests whether adding precise, high-dose radiation (SBRT) to standard second-generation antiandrogen drugs (enzalutamide or abiraterone) can better control prostate cancer that has spread to a few spots and stopped responding to hormone therapy. About 51 men with oligometastatic castration-resistant prostate cancer will receive the combination. Researchers will measure how long it takes for the cancer to progress, overall survival, quality of life, and side effects.

What this could mean

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

Active substance
a combination of stereotactic body radiation therapy (SBRT) and a second-generation antiandrogen (either enzalutamide or abiraterone acetate)
What this could lead to
If successful, this combination could delay cancer progression and improve survival and quality of life for men with oligometastatic castration-resistant prostate cancer.
What could go wrong
This is a small, single-group Phase 2 trial, so results may not be definitive. The added radiation could increase side effects, and the benefit over antiandrogen alone is not yet proven.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 51 people

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

Started

May 2024

Expected to finish

May 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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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 with histologically prostate adenocarcinoma, confirmed with a biopsy. * Testosterone in biochemical castration ranges (testosterone \<50 ng/ml or 1.7 nmol/L) and documented progression: biochemical according to Phoenix criteria or distant by radiological confirmation (PSMA PET/CT or Choline PET/CT) * Biochemistry progression confirmed according to Phoenix criteria, with testosterone in castration levels (testosterone \<50 ng/ml or 1.7 nmol/L). * Radiological confirmation (with choline-PET/CT or 68Ga-PSMA-PET/CT) of ≤5 node or bone metastasis, non-visceral, eligible to receive SBRT treatment (\< 3 cm major diameter in bone metastases, \< 5 cm in lymph node metastases). In the case of very close metastases, a limit of up to 5 treatment fields with SBRT is allowed, instead of 5 metastases. * Patients candidate to receive treatment with abiraterone or enzalutamide as per clinical routine, and treatment selection and prescription assigned by responsible physician before the inclusion in the study. or or who has started treatment no more than 14 days prior to signing, as first-line treatment after a diagnosis of oligoresistance. * Patients must provide written informed consent. * Life expectancy \> 3 months. Exclusion Criteria: * Patients with prostate carcinoma with histology other than adenocarcinoma. * No previous biopsy. * \> 5 metastasis, not approachables in 5 treatment fields * Patients with visceral metastasis and or metastasis non elegible to receive SBRT. * Patients with Testosterone above castration levels * Patients with prior treatment with docetaxel as first-line CRPC treatment (previous docetaxel treatment is permitted when administered as hormone-sensitive metastatic prostate cancer treatment.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma Prostatic Neoplasms, Castration-Resistant

As listed by the trial registrant

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

Prostatic neoplasms, castration-resistant

How to take part

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

  1. The places running it

    6 sites. 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

  • Complexo Hospitalario Universitario De Santiago

    ACTIVE_NOT_RECRUITING

    Santiago de Compostela, Galicia, 15706, Spain

  • Consorci Sanitari De Terrassa

    ACTIVE_NOT_RECRUITING

    Terrassa, Catalonia, 08227, Spain

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, Barcelona, 08036, Spain

  • Hospital Clínico San Carlos

    RECRUITING

    Madrid, Madrid, 28040, Spain

  • Hospital Clínico Universitario De Valladolid

    RECRUITING

    Valladolid, Castille and León, 47003, Spain

  • Hospital De La Santa Creu I Sant Pau

    RECRUITING

    Barcelona, Catalonia, 08041, Spain

  • Hospital Ramón y Cajal

    ACTIVE_NOT_RECRUITING

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario Basurto

    ACTIVE_NOT_RECRUITING

    Bilbao, Basque Country, 48013, Spain

  • Hospital Universitario Central De Asturias

    ACTIVE_NOT_RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario De Salamanca

    ACTIVE_NOT_RECRUITING

    Salamanca, Castille and León, 37007, Spain

  • Hospital Universitario Miguel Servet

    ACTIVE_NOT_RECRUITING

    Zaragoza, Aragon, 50009, Spain

  • Hospital Universitario de Navarra (HUN)

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Hospital Universitario y Politécnico de La Fe

    ACTIVE_NOT_RECRUITING

    Valencia, Valencia, 46026, Spain

  • Hospital de Cruces

    ACTIVE_NOT_RECRUITING

    Barakaldo, Vizcaya, 48903, Spain

  • Instituto Catalán de Oncología Hospitalet

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

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