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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04839367




Registration number
NCT04839367
Ethics application status
Date submitted
7/04/2021
Date registered
9/04/2021

Titles & IDs
Public title
Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPELLER)
Scientific 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
Secondary ID [1] 0 0
CLP03
Universal Trial Number (UTN)
Trial acronym
PROPELLER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 64Cu-SAR-bisPSMA

Experimental: Cohort 1 - 100 MBq 64Cu-SAR-bisPSMA - Participants will receive a single administration, a bolus injection of 100 MBq 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.

Experimental: Cohort 3 - 200 MBq 64Cu-SAR-bisPSMA - Participants will receive a single administration, a bolus injection of 200 MBq 64Cu-SAR-bisPSMA.


Treatment: Drugs: 64Cu-SAR-bisPSMA
64Cu-SAR-bisPSMA
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of 64Cu-SAR-bisPSMA using Common Terminology Criteria for Adverse Events version 5
Timepoint [1] 0 0
11 weeks
Primary outcome [2] 0 0
Efficacy of 64Cu-SAR-bisPSMA in the Detection of Primary Prostate Caner Compared to Histopathology
Timepoint [2] 0 0
11 weeks
Secondary outcome [1] 0 0
Comparison of image quality at varying dose levels of 64CuSAR-bisPSMA for each dose cohort (100 MBq, 150 MBq and 200 MBq).
Timepoint [1] 0 0
11 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/10/2022
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [3] 0 0
GenesisCare CTA, SJOG Medical Clinic - Murdoch
Recruitment postcode(s) [1] 0 0
2751 - Kingswood
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
6150 - Murdoch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Clarity Pharmaceuticals Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04839367