Clinical trial NCT05613842: Copper-64 SAR Bombesin in PSMA Negative Prostate Cancer (BOP)
Official title: Assessment of the Diagnostic Value of 64Cu-SAR-BBN PET Imaging for Men With Negative PSMA PET in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: St Vincent's Hospital, Sydney
Sponsor class: OTHER
Collaborators: name: Clarity Pharmaceuticals Ltd
First posted: 2022-11-14
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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).

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.

Eligibility criteria: 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.

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

Primary outcomes:
measure: Explore the diagnostic potential of 64Cu-SAR-BBN PET In men with rising PSA and negative PSMA PET in the 2 cohorts
timeFrame: 24 months
Secondary outcomes:
measure: To assess the diagnostic value of 64Cu-SAR-BBN PET
timeFrame: 24 months
measure: To evaluate 64Cu-SAR-BBN PET quantitative findings
timeFrame: 24 months
measure: To determine the optimal timing for imaging post BBN injection
timeFrame: 24 months
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
Study officials:
affiliation: Director
name: Louise Emmett, Prof
role: PRINCIPAL_INVESTIGATOR
References: