NCT05613842

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

Assessment of the Diagnostic Value of 64Cu-SAR-BBN PET Imaging for Men With Negative PSMA PET in Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: St Vincent's Hospital, Sydney · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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). 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. Vincent's Hospital, Sydney for study enrolment. 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. Prior 68Ga-PSMA-11 PET scan within 3 months will be collected from the treating doctor. The PI will ensure that the bloods and 68Ga-PSMA-11 PET scan are reviewed to establish final eligibility before participant undergoes 64Cu-SAR-BBN injection (200mbq) and imaging. After screening/Day 0 visit, the participant will undergo two imaging scans at 1 hour and 3 hours after having 64Cu-SAR-BBN administration. Total lesional assessment will be calculated with MIM Encore 6.8.7 (MIM Software, Cleveland) using data from the above time points. Safety assessment will be conducted once the participant is enrolled in the study at screening/Day 0 and 48 hours post 3 hours scan by phone call. All adverse events will be recorded on a case report form as source documentation.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Copper-64 labelled SAR-Bombesin	radiolabeled antagonist analog of bombesin for the diagnosis and treatment of gastrin releasing peptide receptor (GRPR)-positive tumors in adults. The product is Copper-64 labelled SAR-Bombesin (Cu-SAR-BBN). Cu-SAR-BBN uses radioactive forms (radionuclide) of copper, copper-64 (64Cu) to image cancers using Positron Emission Tomography (PET) and then copper-67 (67Cu) for therapy by internal beta radiation. 64Cu-SAR-BBN has 3 basic components; the radionuclide (64Cu), bound via MeCOSar (a bifunctional metal chelator, SAR) to a bombesin analog that targets GRPR.

Timeline

• Start date: 2022-08-09
• Primary completion: 2023-06-06
• Completion: 2023-06-06
• First posted: 2022-11-14
• Last updated: 2023-09-26

Locations

1 site across 1 country: Australia