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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06056830




Registration number
NCT06056830
Ethics application status
Date submitted
21/09/2023
Date registered
28/09/2023
Date last updated
24/09/2024

Titles & IDs
Public title
Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants with High-risk Prostate Cancer Prior to Radical Prostatectomy
Scientific title
Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants with High-risk Prostate Cancer Prior to Radical Prostatectomy: a Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study
Secondary ID [1] 0 0
CLP04
Universal Trial Number (UTN)
Trial acronym
CLARIFY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
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: 64Cu-SAR-bisPSMA - 200MBq 64Cu-SAR-bisPSMA.


Treatment: Drugs: 64Cu-SAR-bisPSMA
All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases
Timepoint [1] 0 0
Up to 16 weeks
Secondary outcome [1] 0 0
Safety and tolerability of 64Cu-SAR-bisPSMA
Timepoint [1] 0 0
Up to 16 weeks
Secondary outcome [2] 0 0
Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers
Timepoint [2] 0 0
Up to 16 weeks
Secondary outcome [3] 0 0
PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs
Timepoint [3] 0 0
Up to 16 weeks
Secondary outcome [4] 0 0
Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer
Timepoint [4] 0 0
Up to 16 weeks
Secondary outcome [5] 0 0
Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching
Timepoint [5] 0 0
Up to 16 weeks

Eligibility
Key inclusion criteria
* At least 18 years of age.
* Signed informed consent.
* Untreated, histologically confirmed adenocarcinoma of the prostate.
* High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.202327 (clinical stage =T3a, or Grade Group =4, or PSA >20 ng/mL).
* Patients electing to undergo RP with PLND.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Administration of any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
* Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
* Patients with known predominant small cell or neuroendocrine PC.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
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
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
383
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
St. Vincent's Sydney - Sydney
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah

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
Clarity Pharmaceuticals
Address 0 0
Clarity Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clarity Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
+61 (0) 2 9209 4037
Fax 0 0
Email 0 0
clinicaltrials@claritypharmaceuticals.com
Contact person for scientific queries

No information has been provided regarding IPD availability


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/NCT06056830