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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05613842




Registration number
NCT05613842
Ethics application status
Date submitted
31/10/2022
Date registered
14/11/2022
Date last updated
26/09/2023

Titles & IDs
Public title
Copper-64 SAR Bombesin in PSMA Negative Prostate Cancer (BOP)
Scientific title
Assessment of the Diagnostic Value of 64Cu-SAR-BBN PET Imaging for Men With Negative PSMA PET in Prostate Cancer
Secondary ID [1] 0 0
062022-01
Universal Trial Number (UTN)
Trial acronym
BOP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Copper-64 labelled SAR-Bombesin

Experimental: Male patients with hormone sensitive disease - who demonstrate rising PSA levels (>0.2ng/ml) following definitive therapy and a negative 68Ga-PSMA-11 PET scan (defined as SUV max < 3);

Experimental: Male patients with metastatic castration resistant prostate cancer - 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.


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Explore the diagnostic potential of 64Cu-SAR-BBN PET In men with rising PSA and negative PSMA PET in the 2 cohorts
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
To assess the diagnostic value of 64Cu-SAR-BBN PET
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
To evaluate 64Cu-SAR-BBN PET quantitative findings
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
To determine the optimal timing for imaging post BBN injection
Timepoint [3] 0 0
24 months

Eligibility
Key inclusion criteria
- 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;

- Male patients 18 years or above with hormone sensitive disease, who demonstrate rising
PSA levels (>0.2ng/ml) following definitive therapy and a negative 68Ga-PSMA-11 PET
scan (defined as SUV max < 3);

- Male patients with metastatic castration resistant prostate cancer 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Significant inter-current acute illness including (but not limited to) requiring the
use of intravenous antibiotics, illness associated with any signs of haemodynamic
instability, or illness as determined by trial investigators that warrant other
emergent treatment;

- ECOG status higher than 2;

- Major surgery (any procedure requiring general anaesthesia) within 6 weeks prior to
screening visit;

- History of significant active cancers requiring treatment other than prostate cancer
as per Investigator discretion;

- Any other reason that the investigator considers that would make the patient
unsuitable to participate in the study.

- eGFR < 40 mL/min/1.73m2

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/06/2023
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital, Sydney
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Clarity Pharmaceuticals Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05613842
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Louise Emmett, Prof
Address 0 0
Director
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries