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

Sponsor
Clarity Pharmaceuticals Ltd (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04839367
Collaborator
(none)
30
3
3
12.6
10
0.8

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:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
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

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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clarity Pharmaceuticals Ltd
ClinicalTrials.gov Identifier:
NCT04839367
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:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2022