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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06907641




Registration number
NCT06907641
Ethics application status
Date submitted
26/03/2025
Date registered
2/04/2025
Date last updated
2/04/2025

Titles & IDs
Public title
Comparative Performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga PSMA-11 PET CT for the Detection of Prostate Cancer Recurrence in the Setting of Biochemical Failure Following Radical Prostatectomy
Scientific title
Comparative Performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga PSMA-11 PET CT for the Detection of Prostate Cancer Recurrence in the Setting of Biochemical Failure Following Radical Prostatectomy
Secondary ID [1] 0 0
CT-2024-CTN-06035-1
Secondary ID [2] 0 0
CLP11 (Co-PSMA)
Universal Trial Number (UTN)
Trial acronym
Co-PSMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer (Post Prostatectomy) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

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

Outcomes
Primary outcome [1] 0 0
Detection rate of lesions per participants, between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Compare the number of lesions outside of the prostatic fossa per patient between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT.
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Compare the diagnostic accuracy of 64Cu-SAR-bisPSMA versus 68Ga PSMA-11 PET/CT in the detection of recurrent or metastatic prostate cancer using a composite standard of truth
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11).
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Compare the total number of lesions between 1 to 4-hour, and 24-hour 64Cu-SAR-bisPSMA PET/CT imaging timepoints.
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Evaluate the frequency of prostatic fossa recurrence on the 24-hour 64Cu-SAR-bisPSMA images compared to the 1 to 4-hour 64Cu-SAR-bisPSMA and 1-hour 68Ga PSMA-11 PET/CT images
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Evaluate biochemical (PSA) response following salvage radiotherapy by 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT imaging parameters in the presence of normal testosterone levels.
Timepoint [6] 0 0
12 months

Eligibility
Key inclusion criteria
* Male patients aged 18 or above
* Ability to provide informed consent documentation indicating that they understand the purpose of, and procedures required for the study, and are willing to participate in the study.
* Prior radical prostatectomy for confirmed adenocarcinoma on histopathology.
* Rising PSA (0.20 - 0.75 ng/mL) following radical prostatectomy with no prior salvage radiotherapy.
* 68Ga PSMA-11 PET/CT within the last 4 weeks for prostate cancer biochemical recurrence.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior, or contraindication to, salvage radiotherapy for biochemically recurrent prostate cancer.
* History of current active malignancy as per investigator discretion other than prostate cancer.
* Known or expected hypersensitivity to 64Cu-SAR-bisPSMA
* Systemic therapy for metastatic prostate cancer including androgen deprivation therapy.

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 2
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
21/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincent's Hospital, Sydney - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital, Sydney
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Clarity Pharmaceuticals Ltd
Address [1] 0 0
Country [1] 0 0

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
Sobia Khan, MBBS, FRACP
Address 0 0
Country 0 0
Phone 0 0
+61 0283821830
Fax 0 0
Email 0 0
[email protected]
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/NCT06907641