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

Phase 1

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Drug: 64Cu-SAR-bisPSMA

• Registration Number: NCT04839367
• Lead Sponsor: Clarity Pharmaceuticals Ltd

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-09
• Study Start: 2021-07-13
• Primary Completion: 2022-10-19
• Study Completion: 2022-10-19
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 2 - 150 MBq 64Cu-SAR-bisPSMA	64Cu-SAR-bisPSMA	Participants will receive a single administration, a bolus injection of 150 MBq 64Cu-SAR-bisPSMA.
Cohort 3 - 200 MBq 64Cu-SAR-bisPSMA	64Cu-SAR-bisPSMA	Participants will receive a single administration, a bolus injection of 200 MBq 64Cu-SAR-bisPSMA.
Cohort 1 - 100 MBq 64Cu-SAR-bisPSMA	64Cu-SAR-bisPSMA	Participants will receive a single administration, a bolus injection of 100 MBq 64Cu-SAR-bisPSMA.

Primary Outcome Measures

Name	Time	Method
Efficacy of 64Cu-SAR-bisPSMA in the Detection of Primary Prostate Caner Compared to Histopathology	11 weeks	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.
Safety and tolerability of 64Cu-SAR-bisPSMA using Common Terminology Criteria for Adverse Events version 5	11 weeks	Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, ECGs and spontaneous AE reporting.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Nepean Hospital; 🇦🇺 Kingswood, New South Wales, Australia

St. Vincent's Hospital; 🇦🇺 Sydney, New South Wales, Australia

GenesisCare CTA, SJOG Medical Clinic; 🇦🇺 Murdoch, Western Australia, Australia