Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04839367
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : March 3, 2022
Sponsor:
Information provided by (Responsible Party):
Clarity Pharmaceuticals Ltd

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Prostatic Neoplasms Drug: 64Cu-SAR-bisPSMA 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 13, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Safety and tolerability of 64Cu-SAR-bisPSMA using Common Terminology Criteria for Adverse Events version 5 [ Time Frame: 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 [ Time Frame: 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). [ Time Frame: 11 weeks ]
    Image quality will be assessed by 2 blinded central readers.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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:

    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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04839367


Contacts
Layout table for location contacts
Contact: Clarity Pharmaceuticals +61 (0) 2 9209 4037 clinicaltrials@claritypharmaceuticals.com

Locations
Layout table for location information
Australia, New South Wales
Nepean Hospital Recruiting
Kingswood, New South Wales, Australia, 2751
Principal Investigator: Veronica Wong, MD         
St. Vincent's Hospital Recruiting
Sydney, New South Wales, Australia, 2010
Principal Investigator: Louise Emmett, MD         
Australia, Western Australia
GenesisCare CTA, SJOG Medical Clinic Recruiting
Murdoch, Western Australia, Australia, 6150
Principal Investigator: Nat Lenzo, MD         
Sponsors and Collaborators
Clarity Pharmaceuticals Ltd
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Clarity Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT04839367    
Other Study ID Numbers: CLP03
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases