Copper-64 SAR Bombesin in PSMA Negative Prostate Cancer (BOP)

What Was Tested

The trial (phase 2) is built around Bombesin.

This phase 2a study will involve enrolment of men presenting with progression of biopsy proven prostate cancer who require imaging for staging/re-staging of their disease.

The participants enrolled will be further sub-stratified into two groups; one group of men with hormone-sensitive disease (cohort A), and a second group of men with castrate-resistant disease being considered for 177Lu-PSMA-617 therapy (Cohort B).

It had two arms (groups): Male patients with hormone sensitive disease (experimental) and Male patients with metastatic castration resistant prostate cancer (experimental).

Being considered for 177Lu-PSMA-617 therapy with known metastatic disease on conventional imaging and sites with low PSMA expression on 68Ga-PSMA-11 PET scan (defined as SUV max \<10) in the presence of disease volume of \> 1cm.

The registry classes the interventions as drug.

More on the Plan

The study will involve men who are being staged or re-staged for metastatic prostate cancer by their treating doctor.

The treating doctor will refer the patient to the nuclear medicine department at St.

Screening and D0 visits will be combined for this study.

Standard of care bloods (haematology, biochemistry, eGFR and PSA) will be collected at screening/D0 if the results are not already available from the treating doctor.

Who Took Part

Enrollment: 30 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ability to provide informed consent documentation indicating that they understand the purpose and procedures required for the study, and are willing to participate in the study;.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: ECOG status higher than 2;; major surgery (any procedure requiring general anaesthesia) within 6 weeks prior to screening visit;; any other reason that the investigator considers that would make the patient unsuitable to participate in the study.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Bombesin study did not mask who received what.

It started in 2022-08-09 with completion listed for 2023-06-06.

It ran at 1 site in Australia.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Explore the diagnostic potential of 64Cu-SAR-BBN PET In men with rising PSA and negative PSMA PET in the 2 cohorts (time frame: 24 months).

It also tracked 3 secondary outcomes, for example To assess the diagnostic value of 64Cu-SAR-BBN PET, To evaluate 64Cu-SAR-BBN PET quantitative findings and To determine the optimal timing for imaging post BBN injection.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Bombesin in 30 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Bombesin compound page, all human trials.