Actively Recruiting
Led by St Vincent's Hospital, Sydney · Updated on 2025-04-02
50
Participants Needed
1
Research Sites
N/A
Total Duration
S
St Vincent's Hospital, Sydney
Lead Sponsor
C
Clarity Pharmaceuticals Ltd
Collaborating Sponsor
Researchers are evaluating the performance of two imaging scans, 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT, in men who have rising prostate-specific antigen (PSA) levels after undergoing radical prostatectomy for prostate cancer. The study aims to determine differences in the number of cancer recurrence lesions detected, diagnostic accuracy compared to standard care, and how the new imaging might influence clinical management decisions. This is a phase 2 clinical trial sponsored by St Vincent's Hospital, Sydney. Participants will receive a single dose of 200 MBq of 64Cu-SAR-bisPSMA during the study. They will undergo three visits: the first includes the standard 68Ga PSMA-11 PET/CT scan and dose, the second involves the 64Cu-SAR-bisPSMA dose and PET/CT scan, and the third visit will have only the 64Cu-SAR-bisPSMA PET/CT scan. A standard blood test will be done either at the first or second visit. During the study, researchers will assess the detection rate of lesions per participant, compare the number of lesions inside and outside the prostate area, and evaluate the diagnostic accuracy of the new scan compared to the standard. They will also study changes in clinical management based on the additional imaging and monitor PSA response after salvage radiotherapy. The total study duration for outcome measures is 12 months, with ongoing safety and effectiveness assessments throughout.
CONDITIONS
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
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single administration of 64Cu-SAR-bisPSMA and undergo PET/CT imaging to detect prostate cancer recurrence.
1 imaging visit (in-person)
Duration - 12 months
Participants are monitored for up to 12 months to assess detection rates and clinical outcomes following imaging.
Follow-up visits as per clinical care
Total: 1 location
1
St Vincent's Hospital, Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
S
Sobia Khan, MBBS, FRACP
L
Louise Emmett, MBChB, FRACP, MD, FAANMS
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Sobia Khan, Nathan Papa, Andrew Kneebone...
https://pubmed.ncbi.nlm.nih.gov/41904043