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

Clarity Pharmaceuticals Ltd (Industry)
Overall Status
Active, not recruiting
CT.gov ID

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Actual Enrollment :
30 participants
Intervention Model:
Sequential Assignment
None (Open Label)
Primary Purpose:
Official Title:
Positron Emission Tomography Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA: A Multi-Centre, Blinded Review, Dose Ranging Phase I Study
Actual Study Start Date :
Jul 13, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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

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

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Secondary Outcome Measures

  1. 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.

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 Nepean Hospital Kingswood New South Wales Australia 2751
2 St. Vincent's Hospital Sydney New South Wales Australia 2010
3 GenesisCare CTA, SJOG Medical Clinic Murdoch Western Australia Australia 6150

Sponsors and Collaborators

  • Clarity Pharmaceuticals Ltd


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Clarity Pharmaceuticals Ltd
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • CLP03
First Posted:
Apr 9, 2021
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2022