Imaging with novel PET radiotracers has significantly influenced radiotherapy decision making and radiation planning in patients with recurrent prostate cancer (PCa). The purpose of this analysis was to report the final results for management decision changes based on 18 F-fluciclovine PET/CT findings and determine whether the decision change trend remained after completion of accrual. Methods: Patients with detectable prostate-specific antigen (PSA) after prostatectomy were randomized to undergo either conventional imaging (CI) only (arm A) or CI plus 18 F-fluciclovine PET/CT (arm B) before radiotherapy. In arm B, positivity rates on CI and 18 F-fluciclovine PET/CT for detection of recurrent PCa were determined. Final decisions on whether to offer radiotherapy and whether to include only the prostate bed or also the pelvis in the radiotherapy field were based on 18 F-fluciclovine PET/CT findings. Radiotherapy decisions before and after 18 F-fluciclovine PET/CT were compared. The statistical significance of decision changes was determined using the Clopper-Pearson (exact) binomial method. Prognostic factors were compared between patients with and without decision changes. Results: All 165 patients enrolled in the study had standard-of-care CI and were initially planned to receive radiotherapy. Sixty-three of 79 (79.7%) patients (median PSA, 0.33 ng/mL) who underwent 18 F-fluciclovine PET/CT (arm B) had positive findings. 18 F-Fluciclovine PET/CT had a significantly higher positivity rate than CI did for the whole body (79.7% vs. 13.9%; P , 0.001), prostate bed (69.6% vs. 5.1%; P , 0.001), and pelvic lymph nodes (38.0% vs. 10.1%; P , 0.001). Twenty-eight of 79 (35.4%) patients had the overall radiotherapy decision changed after 18 F-fluciclovine PET/CT; in 4 of 79 (5.1%), the decision to use radiotherapy was withdrawn because of extrapelvic disease detected on 18 F-fluciclovine PET/CT. In 24 of 75 (32.0%) patients with a final decision to undergo radiotherapy, the radiotherapy field was changed. Changes in overall radiotherapy decisions and radiotherapy fields were statistically significant (P , 0.001). Overall, the mean PSA at PET was significantly different between patients with and without radiotherapy decision changes (P 5 0.033). Conclusion: 18 F-Fluciclovine PET/CT significantly altered salvage radiotherapy decisions in patients with recurrent PCa after prostatectomy. Further analysis to determine the impact of 18 F-fluciclovine PET/CT guidance on clinical outcomes after radiotherapy is in progress.
Purpose: Accurate preoperative staging of prostate cancer (PCa) is essential for treatment planning. Conventional imaging (CI) is limited in detection of metastases. Our primary aim was to determine if [ 18 F]fluciclovine PET/CT is an early indicator of sub-clinical metastasis among patients with high-risk PCa.Materials and Methods: 68 patients with unfavorable intermediate to very high-risk PCa without systemic disease on CI were recruited before robotic radical prostatectomy with extended pelvic lymph node dissection (EPLND). Diagnostic performance of [ 18 F]fluciclovine PET/CT and CI for detection of metastatic disease, and correlation of positivity to node and metastatic deposit size were determined.Results: 57/68 patients completed the protocol, of which 31/57 had nodal metastasis on histology. [ 18 F]fluciclovine PET/CT sensitivity and specificity in detecting nodal metastasis were 55.3% and 84.8% per-patient, 54.8% and 96.4% per-region (right and left pelvis, presacral and non-regional), respectively. Compared with CI, [ 18 F]fluciclovine PET/CT had significantly higher sensitivity on patient-based (55.3% vs 33.3%; p<0.01) and region-based (54.8% vs 19.4%; p<0.01) analysis, detecting metastasis in 7 more patients and 22 more regions; with similar high
Interferon epsilon increased across pregnancy, but was less abundant in women with HSV. This pilot investigation cannot make any definitive conclusions. However, animal models suggest that IFNe may protect against STIs. Thus, larger studies are required to validate expression of IFNe in the reproductive tract of pregnant women with and without genital infections.
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