Study 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

Study Details

Description:

The goal of this clinical trial is to compare 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT in men with biochemical failure following radical prostatectomy. The main questions it aims to answer are: Is there a difference in the number of lesions of prostate cancer recurrence detected between the 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT scans. What is the diagnostic accuracy of 64Cu-SAR-bisPSMA PET/CT compared to 68Ga PSMA-11 PET/CT using a standard of care comparator. Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11).

Sponsor:

St Vincent's Hospital, Sydney

Contacts:

Sobia Khan, MBBS, FRACP

svhs.nm@svha.org.au

+61 0283821830

Louise Emmett, MBChB, FRACP, MD, FAANMS

louise.emmett@svha.org.au

+61 0283821830

Government Study Link:

NCT06907641 - Click here to see study on

ClinicalTrials.gov

Drug Details

64Cu-SAR-bisPSMA
Isotope(s):
    COPPER-64
    Radioisotope: Cu-64
    Theranostic Role: PET Imaging
    T1/2 (Half-Life): 12.7 Hours
    Decay Mode: POSITRON β+, BETA, Electron Capture, GAMMA
    Energy: 0.65 MeV, Gamma 511 keV
    Range: max 2.5mm, mean 0.7mm
    Decay Daughters: Ni64 (Stable), Zn64 (Stable)
    Status: FDA Approval: DETECTNET®
  • COPPER-64
Target(s):
  • PSMA
68Ga PSMA-11
Isotope(s):
    GALLIUM-68
    Radioisotope: Ga-68
    Theranostic Role: PET Imaging
    T1/2 (Half-Life): 68 minutes
    Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
    Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
    Range: N/A
    Decay Daughters: Zn68 (Stable)
    Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
  • GALLIUM-68
Target(s):
  • PSMA
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