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

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
64Cu-SAR-bisPSMA
Sponsored by
Clarity Pharmaceuticals Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Nepean Hospital
  • St. Vincent's Hospital
  • GenesisCare CTA, SJOG Medical Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1 - 100 MBq 64Cu-SAR-bisPSMA

Cohort 2 - 150 MBq 64Cu-SAR-bisPSMA

Cohort 3 - 200 MBq 64Cu-SAR-bisPSMA

Arm Description

Participants will receive a single administration, a bolus injection of 100 MBq 64Cu-SAR-bisPSMA.

Participants will receive a single administration, a bolus injection of 150 MBq 64Cu-SAR-bisPSMA.

Participants will receive a single administration, a bolus injection of 200 MBq 64Cu-SAR-bisPSMA.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 7, 2021
Last Updated
January 12, 2023
Sponsor
Clarity Pharmaceuticals Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04839367
Brief Title
Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPELLER)
Acronym
PROPELLER
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 13, 2021 (Actual)
Primary Completion Date
October 19, 2022 (Actual)
Study Completion Date
October 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clarity Pharmaceuticals Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 - 100 MBq 64Cu-SAR-bisPSMA
Arm Type
Experimental
Arm Description
Participants will receive a single administration, a bolus injection of 100 MBq 64Cu-SAR-bisPSMA.
Arm Title
Cohort 2 - 150 MBq 64Cu-SAR-bisPSMA
Arm Type
Experimental
Arm Description
Participants will receive a single administration, a bolus injection of 150 MBq 64Cu-SAR-bisPSMA.
Arm Title
Cohort 3 - 200 MBq 64Cu-SAR-bisPSMA
Arm Type
Experimental
Arm Description
Participants will receive a single administration, a bolus injection of 200 MBq 64Cu-SAR-bisPSMA.
Intervention Type
Drug
Intervention Name(s)
64Cu-SAR-bisPSMA
Intervention Description
64Cu-SAR-bisPSMA
Primary Outcome Measure Information:
Title
Safety and tolerability of 64Cu-SAR-bisPSMA using Common Terminology Criteria for Adverse Events version 5
Description
Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, ECGs and spontaneous AE reporting.
Time Frame
11 weeks
Title
Efficacy of 64Cu-SAR-bisPSMA in the Detection of Primary Prostate Caner Compared to Histopathology
Description
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.
Time Frame
11 weeks
Secondary Outcome Measure Information:
Title
Comparison of image quality at varying dose levels of 64CuSAR-bisPSMA for each dose cohort (100 MBq, 150 MBq and 200 MBq).
Description
Image quality will be assessed by 2 blinded central readers.
Time Frame
11 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2751
Country
Australia
Facility Name
St. Vincent's Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
GenesisCare CTA, SJOG Medical Clinic
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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