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Radioactive One-Two punch takes on returning prostate cancer

NCT ID NCT07150715

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This phase II trial is testing two radioactive drugs, 225Ac-PSMA-617 and 177Lu-PSMA-617, combined with precise radiation therapy for prostate cancer that has returned and spread to a few spots in the body. The drugs target a protein on cancer cells and deliver radiation to kill them. The study will compare which drug works better with radiation to control the cancer and improve how long patients live without the disease getting worse.

What this could mean

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

Active substance
Radioactive drugs (225Ac-PSMA-617 or 177Lu-PSMA-617) plus stereotactic body radiotherapy
What this could lead to
If successful, this could offer a more effective way to control recurrent prostate cancer that has spread to a few sites, potentially delaying the need for hormone therapy.
What could go wrong
This is a phase II trial with only 107 participants, so results are preliminary. The radioactive drugs can cause side effects like low blood counts and dry mouth, and the treatment may not work for everyone.

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 107 people

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

Started

Dec 2025

Expected to finish

Oct 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.

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: * Oligorecurrent prostate cancer as determined by the presence of 1-5 asymptomatic lesions outside the prostate or prostate bed identified on PSMA PET/CT by local readers * Serum testosterone \> 150 ng/dL * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * No indication for urgent or emergent radiation * Histological confirmation of prostate adenocarcinoma (histology from original treatment acceptable) * White blood cell count ≥ 2.5 × 109/L * Platelets ≥ 100 × 109/L * Hemoglobin ≥ 9 g/dL * Total bilirubin ≤ 1.5 × institutional upper limits of normal (ULN) or up to 3 × ULN if known history of Gilbert's syndrome * Alanine aminotransferase or aspartate aminotransferase ≤ 3.0 × ULN or ≤ 5.0 × ULN for patients with liver metastases * Glomerular filtration rate creatinine-cystatin C (GFRcr-cys) ≥ 60 mL/min 1.73m2 using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) 2021 equation * Serum albumin \> 3.0 g/dL * Partner and patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 3 months after last study drug administration * Ability to understand, and willingness to sign, the written informed consent Exclusion Criteria: * Patients with neuroendocrine or small cell carcinoma of the prostate * Patients with castrate-resistant disease (i.e., prostate specific antigen \[PSA\] \> 0.5 ng/mL with serum testosterone \<150 ng/dL) * Patients who received androgen deprivation therapy or cytotoxic chemotherapy within 6 months of trial enrolment * Concurrent systemic therapy for a solid organ malignancy * Spinal cord compression * Inability to lie flat * Known hypersensitivity to components of 177-Lu-PSMA-617 or 225-Ac-Lu-PSMA-617 * Inadequate renal function of GFRcr-cys \< 60 mL/min 1.73m2 using the CKD-EPI 2021equation * Total bilirubin \> 1.5 × ULN or \> 3.0 × ULN if known history of Gilbert's syndrome * Alanine aminotransferase or aspartate aminotransferase \> 3 × ULN (or 5 × ULN for patients with known liver metastases) * De novo oligometastatic disease

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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.

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

  • UCLA / Jonsson Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90095, United States

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