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Optimized Patient Inclusion for NaF PET Response-Based Biopsies

A Roth

A Roth*, S Harmon , T Perk , R Jeraj , University of Wisconsin, Madison, WI


SU-F-J-6 (Sunday, July 31, 2016) 3:00 PM - 6:00 PM Room: Exhibit Hall

Purpose: A method to guide mid-treatment biopsies using quantitative [F-18]NaF PET/CT response is being investigated in a clinical trial. This study aims to develop methodology to identify patients amenable to mid-treatment biopsy based on pre-treatment imaging characteristics.

Methods: 35 metastatic prostate cancer patients had NaF PET/CT scans taken prior to the start of treatment and 9-12 weeks into treatment. For mid-treatment biopsy targeting, lesions must be at least 1.5 cm³ and located in a clinically feasible region (lumbar/sacral spine, pelvis, humerus, or femur). Three methods were developed based on number of lesions present prior to treatment: a feasibility-restricted method, a location-restricted method, and an unrestricted method. The feasibility restricted method only utilizes information from lesions meeting biopsy requirements in the pre-treatment scan. The unrestricted method accounts for all lesions present in the pre-treatment scan. For each method, optimized classification cutoffs for candidate patients were determined.

Results: 13 of the 35 patients had enough lesions at the mid-treatment for biopsy candidacy. Of 1749 lesions identified in all 35 patients at mid-treatment, only 9.8% were amenable to biopsy. Optimizing the feasibility-restricted method required 4 lesions at pre-treatment meeting volume and region requirements for biopsy, resulting patient identification sensitivity of 0.8 and specificity of 0.7. Of 6 false positive patients, only one patient lacked lesions for biopsy. Restricting for location alone showed poor results (sensitivity 0.2 and specificity 0.3). The optimized unrestricted method required patients have at least 37 lesions in pretreatment scan, resulting in a sensitivity of 0.8 and specificity of 0.8. There were 5 false positives, only one lacked lesions for biopsy.

Conclusion: Incorporating the overall pre-treatment number of NaF PET/CT identified lesions provided best prediction for identifying candidate patients for mid-treatment biopsy. This study provides validity for prediction-based inclusion criteria that can be extended to various clinical trial scenarios.

Funding Support, Disclosures, and Conflict of Interest: Funded by Prostate Cancer Foundation

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