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New combo attack on returning prostate cancer shows promise in early trial

NCT ID NCT05496959

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether giving a radioactive drug (177Lu-PSMA) before precise radiation (SBRT) can better control prostate cancer that has come back in 1 to 5 spots. About 93 men with recurrent prostate cancer will receive either SBRT alone or the drug first, then SBRT. The goal is to see if the combination delays cancer progression more effectively.

What this could mean

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

Active substance
Lutetium Lu-177 PNT2002 (a radioactive drug that targets prostate cancer cells)
What this could lead to
If it works, this combination could offer a more effective way to control prostate cancer that has returned in a few spots, potentially delaying further spread.
What could go wrong
This is a mid-stage trial with only 93 people, so results may not apply to everyone. The treatment involves radiation, which can cause side effects like fatigue or damage to nearby organs.

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

93 people

The number who actually took part.

Started

Sep 2022

Expected to finish

Sep 2033

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

Anyone

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 * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * No indication for urgent or emergent radiation * Histologic confirmation of prostate adenocarcinoma (histology from original treatment acceptable) * White blood cell count \>= 2.5 × 10\^9/L * Platelets \>= 100 × 10\^9/L * Hemoglobin \>= 9 g/dL * Total bilirubin =\< 1.5 × institutional upper limit 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 * Serum creatinine =\< 1.5 × ULN or creatinine clearance \>= 50 mL/min * 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., PSA \> 0.5 ng/mL with serum testosterone \< 150 ng/dL) * Patients who received androgen deprivation therapy within 6 months of trial enrollment * Concurrent systemic therapy for a solid organ malignancy * Spinal cord compression * Inability to lie flat * Known hypersensitivity to components of 177Lu-PNT2002 * Serum creatinine \> 1.5 × ULN or creatinine clearance \< 50 mL/min * 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.

Contacts and locations

Locations

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095, United States

More trials for these conditions

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