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New radiation therapy shows promise for slowing prostate cancer spread

NCT ID NCT04443062

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tested a drug called Lutetium-177-PSMA-617, which delivers radiation directly to prostate cancer cells. It included 58 men with prostate cancer that had spread to a few spots in bones or lymph nodes but was still hormone-sensitive. The study compared the drug to standard care to see if it could delay disease progression.

What this could mean

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

Active substance
Lutetium-177-PSMA-617 (a targeted radioactive drug)
What this could lead to
If successful, this could offer a new treatment option for men with prostate cancer that has spread to a few places, potentially delaying the need for stronger hormone therapy.
What could go wrong
This is a small, early-phase study with only 58 participants. The treatment may not work better than standard care, and there are risks from radiation exposure to healthy tissues.

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

58 people

The number who actually took part.

Started

Jul 2020

Finished

Jan 2026

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: * Histological proven adenocarcinoma of the prostate with sufficient archived tumor material. This material has to be archived till study closure. * Biochemical recurrence (PSA \> 1.0 µg/l). * PSA-doubling time \< 6 months. Serum PSA progression is defined as 2 consecutive rising PSA values measured at least 1 week apart. The minimal start value is 0.2 µg/l. * 18F-PSMA-PET-CT positive metastases in bones and/or lymph nodes (N1/M1ab): ≥1, maximally 5 metastases. * Local treatment for oligo-metastases with radiotherapy or surgery appears to be no option anymore (due to prior treatment or the location of the metastatic lesions or if the patient refuse these treatments). * No prior hormonal therapy (including any androgen directed treatment such as finasteride, dutasteride, bicalutamide, apalutamide, abiraterone or enzalutamide) or taxane based chemotherapy (docetaxel or cabazitaxel); testosterone \> 1.7 nmol/l. Exception: local prostate cancer treated with local radiotherapy plus adjuvant ADT; these patients need to be stopped with ADT at least 6 months. * A detectable lesion on the 18F-PSMA PET/CT with significant PSMA avidity, defined by a SUVmax \> 15 (partial volume corrected). * ECOG 0-1 * Patients must have a life expectancy \>6 months. * Laboratory values: * White blood cells \> 3.0 x 109/l * Platelet count \> 75 x 109/l * Hemoglobin \> 6.2 mmol/l * ASAT, ALAT \< 3 x ULN * MDRD-GFR ≥ 50 ml/min * Signed informed consent. Exclusion Criteria: * A known subtype other than prostate adenocarcinoma. * Previous PSMA based radioligand treatment. * Visceral or brain metastases. * Any medical condition present that in the opinion of the investigator will affect patients' clinical status when participating in this trial. * Prior hip replacement surgery potentially influencing performance of PSMA PET/CT. * Sjogren's syndrome * A second active malignancy other than prostate cancer. * Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Amsterdam UMC

    Amsterdam, Netherlands

  • German Oncology Center

    Limassol, Cyprus

  • Radboud University

    Nijmegen, Netherlands

  • University Medical Center Groningen

    Groningen, Netherlands

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