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Clinical Trial
. 2025 Aug;52(10):3709-3719.
doi: 10.1007/s00259-025-07208-z. Epub 2025 Mar 31.

Prospective comparison of 18F-PSMA-1007 PET/CT and MRI with histopathology as the reference standard for intraprostatic tumour detection and T-staging of high-risk prostate cancer

Aino Kivikallio  1   2 , Simona Malaspina  2   3 , Irena Saarinen  1   2 , Marko Seppänen  2   3 , Mikael Anttinen  2   4 , Ivan Jambor  5   6 , Janne Verho  2   5 , Jukka Kemppainen  2   3 , Hannu J Aronen  2   5 , Peter J Boström  2   4 , Otto Ettala #  2   4 , Pekka Taimen #  7   8
Affiliations
Clinical Trial

Prospective comparison of 18F-PSMA-1007 PET/CT and MRI with histopathology as the reference standard for intraprostatic tumour detection and T-staging of high-risk prostate cancer

Aino Kivikallio et al. Eur J Nucl Med Mol Imaging. 2025 Aug.

Abstract

Purpose: To prospectively compare the ability of 18F-PSMA-1007 PET/CT and whole-body MRI (WBMRI) with DWI to detect prostate cancer (PCa) lesions and assess their local stage. Additionally, to evaluate the correlation between PSMA uptake on PET/CT and PSMA expression as assessed by immunohistochemistry.

Methods: Men with newly diagnosed unfavourable intermediate or high-risk PCa underwent 18F-PSMA-1007 PET/CT and WBMRI with DWI before robot-assisted laparoscopic prostatectomy. Diagnostic accuracy for intraprostatic tumour localization, seminal vesicle invasion (SVI), and extraprostatic extension (EPE) was evaluated using whole-mount prostatectomy specimens as the reference standard. SUVmax was compared with immunohistochemical PSMA staining intensity quantified using QuPath software.

Results: 19 patients with 39 intraprostatic lesions in histopathology were included. The overall lesion detection rates for PET/CT were 84.6% and 82.1% for two independent readers, compared to 74.4% and 46.2% for MRI readers. The detection rates of index lesions were 94.7% for PET/CT and 74.0-84.0% for MRI, whereas those of non-index lesions were 70.0-75.0% for PET/CT and 20.0-65.0% for MRI. For detecting EPE, AUC values were 0.500-0.591 for PET/CT and 0.648-0.682 for MRI. For detecting SVI, AUC values ranged from 0.629 to 0.700 across both modalities. SUVmax showed a weak correlation with immunohistochemical expression of PSMA multiplied by lesion diameter (Spearman's ρ = 0.427, p = 0.013). Lesion diameters measured using 30% and 40% of SUVmax, as well as prostate SUVbackground x2, showed the closest agreement with histopathological measurements.

Conclusion: 18F-PSMA-1007 PET/CT demonstrated high sensitivity in localizing intraprostatic carcinoma lesions but seemed inferior to WBMRI in detecting EPE. PSMA uptake appears to depend on both PSMA expression and lesion size. These findings highlight the complementary roles of PET/CT and MRI in the detection and tumor staging of PCa.

Clinical trial registration: Clinicaltrials.gov ID: NCT03537391. Registered 25 May 2018.

Keywords: 18F-PSMA-1007 PET/CT; Immunohistochemistry; PSMA; Primary staging; Prostate cancer; Tumour staging; WBMRI.

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Conflict of interest statement

Declarations. Ethics approval: This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of the Hospital District of Southwest Finland. Consent to participate: Informed consent was obtained from all individual participants included in the study. Competing interests: The authors have no relevant financial or non-financial interests to disclose.

Figures

Fig. 1
Fig. 1
PET/CT accurately detected intraprostatic tumours with strong PSMA staining. (a) HE-stained cross section of mid gland, low magnification. Three PCa lesions are present: right posterior (index lesion, Gleason 4 + 4), left posterior (Gleason 4 + 3) and left anterior (Gleason 3 + 4). (b) Immunohistochemical PSMA staining, low magnification. The right and left posterior lesions show strong staining intensity (mean DAB ODmax 1.164 and 1.838), while the left anterior lesion shows weak to moderate staining intensity (mean DAB ODmax 0.241). (c) Fused PET/CT images of the prostate show two pathological uptakes (arrows), one on the right posterior mid gland (SUVmax 9,6) and the other on the left posterior mid gland (SUVmax 5,8). These lesions correspond to the Gleason 4 + 4 and 4 + 3 lesions in histopathology. (d-e) WBMRI DWI shows diffusion restriction in the right posterior and left anterior lesion (arrows), while the left posterior lesion is not confidently visualised. Scale bar 5 mm (a-b)
Fig. 2
Fig. 2
Heterogenous PSMA staining leading to the underestimation of lesion size in PET/CT. (a) HE-stained cross section of mid gland, low magnification. A large index lesion (Gleason 4 + 5) covers the left lobe and shows extensive EPE as well as bilateral SVI. (b) Immunohistochemical PSMA staining, low magnification. PSMA staining intensity is heterogeneous. More homogenous, strong PSMA expression is seen around and in the left seminal vesicle (arrowhead). (c) Immunohistochemical PSMA staining, high magnification. Abundant cribriform growth pattern is seen. PSMA staining is notably heterogenic with completely negative glands mixed with highly positive glands. (d) Fused PET/CT images show pathological uptake (arrow) in the posterior base and left seminal vesicle (SUVmax 7.0). The remaining lesion of the left lobe, the IHC staining of which was heterogenous, does not show clear pathological uptake. (e) WBMRI DWI shows diffusion restriction in the lesion in the left mid gland and base (arrow). EPE and SVI was detected on the left. Scale bars 5 mm (a-b) and 0.5 mm (c)
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