Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPELLER)

Study Overview
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Brief Summary
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The aim of this study is to determine the safety and tolerability of 64Cu-SARbisPSMA in participants with untreated, confirmed Prostate Cancer.

Detailed Description
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This is a multi-centre, blinded review, dose ranging, non-randomized study of 64Cu-SAR-bisPSMA administered to participants with confirmed Prostate Cancer. 30 eligible participants will be allocated (1:1:3) to 1 of 3 dosing cohorts to be administered with 64Cu-SAR-bisPSMA 100 MBq, 150 MBq or 200 MBq. PET/CT scan images will be sent to blinded central readers to assess the capacity of 64Cu-SAR-bisPSMA to detect primary Prostate Cancer, to assess image quality of the various dose cohorts, and to assess the PET/CT scan features of 64Cu-SAR-bisPSMA in comparison standard of care.

Official Title
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Positron Emission Tomography Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA: A Multi-Centre, Blinded Review, Dose Ranging Phase I Study

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: 64Cu-SAR-bisPSMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent; ≥18 years of age; Life expectancy >3 months; Confirmation of Prostate Cancer by histopathology and planned radical prostatectomy; Have ≥1 of the following intermediate- to high-risk features: PSA level greater than or equal to 10.0 ng/ml within 12 weeks prior to enrolment; International Society of Urological Pathology (ISUP) Grade Group 3 (i.e. Gleason score of 7 (4+3) or above; Clinical stage greater than or equal to T2b; Participants must have adequate renal function; Sexually active participants who have female partners of childbearing potential: Partner and/or participant must agree to use an acceptable form of contraception. Further participants must refrain from donating sperm; A 68Ga-PSMA-11 PET/CT scan performed within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SAR-bisPSMA. Exclusion Criteria: Prior prostatectomy or any other treatment for Prostate Cancer, including Androgen Deprivation Therapy and radiation therapy; Previous treatment with PSMA-targeted therapy within 3 months prior to enrolment, and administration of other investigational agents within 4 weeks prior to entering the study (except 68Ga-PSMA-11); Known hypersensitivity to the components of 64Cu-SAR-bisPSMA; Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer, superficial bladder cancer; Any serious medical condition which the Investigator feels may interfere with the procedures or evaluations of the study; Patients unwilling or unable to comply with protocol or with a history of noncompliance or inability to grant informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 - 100 MBq 64Cu-SAR-bisPSMA<br>Participants will receive a single administration, a bolus injection of 100 MBq 64Cu-SAR-bisPSMA. | Drug: 64Cu-SAR-bisPSMA<br>* 64Cu-SAR-bisPSMA<br>|
| Experimental: Cohort 2 - 150 MBq 64Cu-SAR-bisPSMA<br>Participants will receive a single administration, a bolus injection of 150 MBq 64Cu-SAR-bisPSMA. | Drug: 64Cu-SAR-bisPSMA<br>* 64Cu-SAR-bisPSMA<br>|
| Experimental: Cohort 3 - 200 MBq 64Cu-SAR-bisPSMA<br>Participants will receive a single administration, a bolus injection of 200 MBq 64Cu-SAR-bisPSMA. | Drug: 64Cu-SAR-bisPSMA<br>* 64Cu-SAR-bisPSMA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of 64Cu-SAR-bisPSMA using Common Terminology Criteria for Adverse Events version 5 | Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, ECGs and spontaneous AE reporting. | 11 weeks | 
| Efficacy of 64Cu-SAR-bisPSMA in the Detection of Primary Prostate Caner Compared to Histopathology | Efficacy will be measured by the proportion of 64Cu-SAR-bisPSMA PET/CT scans assessed as True Positive or False Negative for primary Prostate Cancer, as confirmed by histopathology. | 11 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of image quality at varying dose levels of 64CuSAR-bisPSMA for each dose cohort (100 MBq, 150 MBq and 200 MBq). | Image quality will be assessed by 2 blinded central readers. | 11 weeks |