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Tiny trial tests Dual-Radiation attack on returning prostate cancer

NCT ID NCT05230251

Disease control Sponsor: Glenn Bauman 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This early study tested whether adding a radioactive drug (177Lu-PSMA) to standard brachytherapy is safe and feasible for men whose prostate cancer returned after initial radiation. Only 3 men took part. The goal was to see if the combination could control cancer both in the prostate and elsewhere in the body. Because it was so small, the results are very preliminary.

What this could mean

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

Active substance
177Lu-PNT2002 (a radioactive drug that targets prostate cancer cells)
What this could lead to
If it works, this combination could offer a new way to treat prostate cancer that has come back after initial radiation, potentially targeting cancer both inside and outside the prostate.
What could go wrong
This was a very small, early-phase study with only 3 participants, so results may not apply to most patients. The treatment also carries risks from radiation exposure.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

3 people

The number who actually took part.

Started

Mar 2022

Finished

Dec 2024

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: * Men with prostate adenocarcinoma treated with prior primary radiotherapy at least 2 years previously * Biochemical failure according to the Phoenix criteria(Roach et al. 2006) * PSMA PET demonstrating isolated uptake (SUV\>3) within the prostate * Biopsy confirmation of local recurrence within the prostate * Not currently experiencing genitourinary (GU) or gastrointestinal (GI) Grade 3 or higher toxicity associated with prior treatment * Adequate marrow function (Absolute neutrophil count ≥ 1.5 x 109/L -Platelet count ≥ 100 x 109/L -Hemoglobin ≥ 90 g/L with no transfusions in the past 2 weeks) * Adequate renal function: Estimated creatinine clearance ≥ 30 ml/min according to Cockroft Gault equation: (140 - age) x (weight in kg) / 72 x (serum creatinine) * Adequate liver function: Total bilirubin \< 1.5 x upper limit of normal (ULN). Alanine aminotransferase (ALT) \< 3.5 x ULN * No contraindication to treatment with \[177Lu-PSMA Agent\] * No contraindication to MRI * No contraindication to therapy with high dose rate brachytherapy under general anaesthetic Exclusion Criteria: * Does not meet eligibility criteria * Prior ablative radiotherapy to the prostate (prior HDR or LDR brachytherapy or SBRT/SABR to prostate) * Documented extraprostatic or distant recurrence on PSMA PET * Consent not obtained or declines randomization * Declines HDR salvage or not fit for HDR salvage procedure * Concurrent use of hormone therapy

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer

As listed by the trial registrant

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

Prostate cancer

Contacts and locations

Locations

  • London Health Sciences Centre

    London, Ontario, N6A5W9, Canada

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