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A Prospective Pilot Study Investigating Performance of 18F-Fluciclovine PET Imaging for Detection of Prostate Cancer 2 Years Following Primary Partial Gland Cryoablation

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Abstract

Purpose

The goal of partial gland ablation (PGA) is to eradicate focal lesions of clinically significant prostate cancer (csPCa) with minimal adverse impact on functional outcomes. The primary objective of this study is to characterize the performance of 18F-Fluciclovine PET imaging for detection of prostate cancer following PGA.

Materials and Methods

Subjects 2 years following primary partial gland cryoablation (PPGCA) were invited to participate in an IRB-approved study providing they met the following inclusion criteria: a single reported mpMRI region of interest (ROI) concordant with biopsy Gleason Grade Group (GGG) < 4, no gross extra-prostatic extension on mpMRI, and no GGG > 1 or GGG 1 with a core length > 6 mm on contralateral systematic biopsy. 18F-Fluciclovine PET MRI imaging of the prostate was performed followed by in and out-of-field biopsies.

Results

Twenty-seven men who met eligibility criteria participated in the prospective study. In-field and out-of-field csPCa recurrence rate was 7.4% and 22.2%, respectively. The sensitivity and positive predictive value of mpMRI and PET imaging did not reach performance to reliably inform who should undergo prostate biopsy.

Conclusion

At 2 years following PPGCA, the rate of in-field csPCa was exceedingly low indicating a limited role for imaging to inform in-field biopsy decisions. The csPCa detection rate of out-of-field recurrence was 22% which provides an opportunity for imaging to inform out-of-field biopsy decisions. Based on our findings, 18F-Fluciclovine PET MRI cannot be used to inform who should undergo out-of-field prostate biopsy at 2 years following PPGCA.

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Data Availability

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Funding

This study was funded by BlueEarthDx.

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Authors and Affiliations

  1. Department of Urology, New York University Grossman School of Medicine, New York, NY, USA

    Azadeh Nazemi, William C. Huang, James Wysock, Samir S. Taneja, Rozalba Gogaj & Herbert Lepor

  2. Department of Nuclear Medicine, New York University Grossman School of Medicine, New York, NY, USA

    Kent Friedman

Authors
  1. Azadeh Nazemi
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  2. William C. Huang
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  3. James Wysock
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  4. Samir S. Taneja
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  5. Kent Friedman
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  6. Rozalba Gogaj
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  7. Herbert Lepor
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Contributions

A Nazemi: data collection, data analysis, manuscript writing/editing. WC Huang: protocol/project development, data collection, manuscript writing/editing. J Wysock: protocol/project development, data collection, manuscript writing/editing. SS Taneja: protocol/project development, data collection, manuscript writing/editing. R Gogaj: data collection, data analysis. K Friedman: data collection, data analysis. H Lepor: protocol/project development, data collection, data analysis, manuscript writing/editing.

Corresponding author

Correspondence to Herbert Lepor.

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Conflict of Interest

Azadeh Nazemi, William C Huang, James Wysock, Samir S Taneja, Kent Friedman, Rozalba Gogaj, and Herbert Lepor declare that they have no conflict of interest.

Ethics Approval

The study was approved by the institutional review board of New York University (s17-00354), and informed consent was obtained from all individual participants included in the study. All procedures performed in studies involving human participants were in accordance with the Helsinki declaration as revised in 2013 and its later amendments.

Consent to Participate

Informed consent was obtained from all individual participants included in the study.

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Nazemi, A., Huang, W.C., Wysock, J. et al. A Prospective Pilot Study Investigating Performance of 18F-Fluciclovine PET Imaging for Detection of Prostate Cancer 2 Years Following Primary Partial Gland Cryoablation. Nucl Med Mol Imaging 56, 196–201 (2022). https://doi.org/10.1007/s13139-022-00755-5

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  • DOI: https://doi.org/10.1007/s13139-022-00755-5

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