European urology · 2026
Prospective Comparison of 64Copper [64Cu]SAR-bisPSMA vs 68Gallium[68Ga] PSMA-11 PET/CT for Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy (Co-PSMA Trial).
Клиническое исследование II фазыСравнительное исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Khan Sobia, Papa Nathan, Kneebone Andrew, Eade Thomas, Ayati Narjess, Nguyen Andrew, Wong Keith, Chen Jeff, Ho Bao, Idiare Jordan, Sidhom George, Roberts Matthew J, Thompson James, Sharma Shikha, Weir Shraddha, Devitt Katrina, Kooner Raji, Lieng Hester, Rasiah Kris, Olphert Joanna, de Leon Jeremy, Hruby George, Stricker Phillip, Emmett Louise
Аннотация
BACKGROUND AND OBJECTIVE: Prostate-specific membrane-antigen positron emission tomography (PSMA-PET) has transformed management of prostate cancer biochemical recurrence (BCR) with higher diagnostic accuracy than previous imaging modalities. 64Cu-SAR-bisPSMA PET/computed tomography (CT) (64Cu-bisPSMA) is a bivalent-PSMA-peptide with 12.7-hr half-life. The study objective was detection rate (per-patient) comparison between 64Cu-bisPSMA and 68GaPSMA-11 PET/CT (68Ga-PSMA) in BCR post radical prostatectomy (RP) (NCT06907641).
METHODS: This prospective imaging trial enrolled 50 participants with BCR (PSA 0.2-0.75 ng/ml). 64Cu-bisPSMA (1 and 24 hr) and 68Ga-PSMA were acquired within 3-wk. Images were prospectively reported, and triple read for concordance. Management impact was evaluated after 68Ga-PSMA and 64Cu-bisPSMA. A reference standard (RS) for accuracy included biopsy, targeted treatment response (no androgen deprivation therapy), PSA increase/decrease on observation or repeat imaging (64Cu-bisPSMA). The primary endpoint was mean per-participant lesional difference. Paired t tests and mixed-effects Poisson regression assessed lesion number differences between scans.
KEY FINDINGS AND LIMITATIONS: Median prostate specific antigen (PSA) was 0.43 (interquartile range: 0.31-0.63). Mean per-participant lesions were higher in 64Cu-bisPSMA (1.26) versus 68GaPSMA (0.48), difference 0.78 (95% CI: 0.52-1.04), ratio 2.63 (95% CI: 1.64-4.20) (p < 0.0001). At a per-participant level 78% (39/50) were positive on 24-hr 64Cu-bisPSMA compared to 36% (18/50) on 68GaPSMA. Management changed between scans in 22/50 (44%). 64Cu-bisPSMA were triple concordant in 84% (42/50) and 68Ga-PSMA reads in 80% (40/50). RS-true positive was 71% (24/34) versus 29% (10/34) and RS-false negative rate was 21% (7/34) versus 65% (22/34) for 64Cu-bisPSMA versus 68Ga-PSMA, respectively.
CONCLUSION AND CLINICAL IMPLICATIONS: 64Cu-bisPSMA-PET/CT identifies a higher number of disease recurrences than 68Ga PSMA-PET/CT with substantial management impact and a high RS true positive rate in men with BCR post RP.
METHODS: This prospective imaging trial enrolled 50 participants with BCR (PSA 0.2-0.75 ng/ml). 64Cu-bisPSMA (1 and 24 hr) and 68Ga-PSMA were acquired within 3-wk. Images were prospectively reported, and triple read for concordance. Management impact was evaluated after 68Ga-PSMA and 64Cu-bisPSMA. A reference standard (RS) for accuracy included biopsy, targeted treatment response (no androgen deprivation therapy), PSA increase/decrease on observation or repeat imaging (64Cu-bisPSMA). The primary endpoint was mean per-participant lesional difference. Paired t tests and mixed-effects Poisson regression assessed lesion number differences between scans.
KEY FINDINGS AND LIMITATIONS: Median prostate specific antigen (PSA) was 0.43 (interquartile range: 0.31-0.63). Mean per-participant lesions were higher in 64Cu-bisPSMA (1.26) versus 68GaPSMA (0.48), difference 0.78 (95% CI: 0.52-1.04), ratio 2.63 (95% CI: 1.64-4.20) (p < 0.0001). At a per-participant level 78% (39/50) were positive on 24-hr 64Cu-bisPSMA compared to 36% (18/50) on 68GaPSMA. Management changed between scans in 22/50 (44%). 64Cu-bisPSMA were triple concordant in 84% (42/50) and 68Ga-PSMA reads in 80% (40/50). RS-true positive was 71% (24/34) versus 29% (10/34) and RS-false negative rate was 21% (7/34) versus 65% (22/34) for 64Cu-bisPSMA versus 68Ga-PSMA, respectively.
CONCLUSION AND CLINICAL IMPLICATIONS: 64Cu-bisPSMA-PET/CT identifies a higher number of disease recurrences than 68Ga PSMA-PET/CT with substantial management impact and a high RS true positive rate in men with BCR post RP.
Предметные рубрики MeSH
AgedHumansMaleMiddle AgedAntigens, SurfaceCopper RadioisotopesEdetic AcidGallium IsotopesGallium RadioisotopesKallikreinsNeoplasm Recurrence, LocalOligopeptidesPositron Emission Tomography Computed TomographyProspective StudiesProstate-Specific AntigenProstatectomyProstatic NeoplasmsRadiopharmaceuticals