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

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

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

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Drug: 64Cu-SAR-bisPSMA

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kingswood, New South Wales, Australia, 2751
      • Nepean Hospital
    • Sydney, New South Wales, Australia, 2010
      • St. Vincent's Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • GenesisCare CTA, SJOG Medical Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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:

  1. PSA level greater than or equal to 10.0 ng/ml within 12 weeks prior to enrolment;
  2. International Society of Urological Pathology (ISUP) Grade Group 3 (i.e. Gleason score of 7 (4+3) or above;
  3. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clarity Pharmaceuticals Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2021
• Primary Completion (Actual): October 19, 2022
• Study Completion (Actual): October 19, 2022

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CLP03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No