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New combo therapy aims to cut hormone treatment for prostate cancer

NCT ID NCT05162573

Disease control Sponsor: The Netherlands Cancer Institute 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase study tested a new approach for men with prostate cancer that has spread to nearby lymph nodes. The standard treatment combines radiation with 2-3 years of hormone therapy, which can cause lasting side effects. Researchers added a targeted radioactive drug (Lu-PSMA) to the radiation, hoping to better control the cancer and possibly reduce the need for long-term hormone therapy. The study involved 14 participants and focused on finding the safest dose of Lu-PSMA when given with radiation.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

14 people

The number who actually took part.

Started

Dec 2021

Finished

Sep 2025

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 prostate cancer; * cT2-4, partly determined by MRI; * N1, determined by LND/SNP and/or PSMA PET/CT; * iM0, determined by PSMA PET/CT; * Accepted for curative intent treatment with EBRT of the prostate and regional nodes + 3y ADT; * Visually PSMA-positive primary tumor and nodes, largest lesion ≥ average liver uptake; * WHO performance score 0-1; * Age \> 18 years; * For patients who have partners of childbearing potential: Willingness to use a method of birth control with adequate barrier protection during the study and for 6 months after the study drug administration; and * Signed written informed consen Exclusion Criteria: * Inability to comply to study procedures; * Inability to adhere to radiation safety measures in hospital or at home; * Inability to undergo the required biodistribution scans; * Prior or current malignant disease with potential impact on treatment outcome or survival; * Prior treatment with EBRT; * Prior treatment with ADT, already initiated \>1 month before the start of EBRT; * Prior treatment with radionuclide therapies, 177Lu-PSMA-617 or other; * Reduced bone marrow reserve (Hb\<6 mmol/L, Leukocytes\<2.5 10E9/L, or Platelets\<100 10E9/L not older than 1 month before start of EBRT); * Reduced renal function (GFR \< 60 not older than 1 month before start of EBRT); * Reduced salivary gland function (history of prior salivary gland disease); or * Miction problems requiring pre-treatment with ADT.

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

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

Prostatic neoplasm

Contacts and locations

Locations

  • Netherlands Cancer Institute

    Amsterdam, 1066 CX, Netherlands

  • UMC Utrecht

    Utrecht, 3508 GA, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.