Impact of ⁶⁸Ga-PSMA-11 PET/CT on the Management of Prostate Cancer Patients with Biochemical Recurrence

Abstract

In this prospective survey of referring physicians, we investigated whether and how Ga-labeled prostate-specific membrane antigen 11 (Ga-PSMA-11) PET/CT affects the implemented management of prostate cancer patients with biochemical recurrence (BCR). We conducted a prospective survey of physicians (NCT02940262) who referred 161 patients with prostate cancer BCR (median prostate-specific antigen value, 1.7 ng/mL; range, 0.05-202 ng/mL). Referring physicians completed one questionnaire before the scan to indicate the treatment plan withoutGa-PSMA-11 PET/CT information (Q1; = 101), one immediately after the scan to denote intended management changes (Q2; = 101), and one 3-6 mo later to document the final implemented management (Q3; = 56). The implemented management was also obtained via electronic chart review or patient contact ( = 45). A complete documented management strategy (Q1 + Q2 + implemented management) was available for 101 of 161 patients (63%). Seventy-six of these (75%) had a positiveGa-PSMA-11 PET/CT result. The implemented management differed from the prescan intended management (Q1) in 54 of 101 patients (53%). The postscan intended management (Q2) differed from the prescan intended management (Q1) in 62 of 101 patients (61%); however, these intended changes were not implemented in 29 of 62 patients (47%). Pelvic nodal and extrapelvic metastatic disease on Ga-PSMA-11 PET/CT (PSMA T0N1M0 and PSMA T0N1M1 patterns) was significantly associated with implemented management changes ( = 0.001 and 0.05). Information fromGa-PSMA-11 PET/CT brings about management changes in more than 50% of prostate cancer patients with BCR (54/101; 53%). However, intended management changes early after Ga-PSMA-11 PET/CT frequently differ from implemented management changes.

How does 68Ga‐prostate‐specific membrane antigen positron emission tomography/computed tomography impact the management of patients with prostate cancer recurrence after surgery?

“…A recent metanalysis including 15 studies showed pooled management changes in 54% of patients by using PSMA PET/CT, with wide differences between the series, due to the heterogeneous populations included, and the different methods to value and classify the concept of clinical impact . The present results are consistent with those previously reported as 68 Ga‐PSMA PET/CT determines an overall clinical impact of 67%, with a major change in therapeutic strategy in 64% of patients.…”

Appropriate Use Criteria for Imaging Evaluation of Biochemical Recurrence of Prostate Cancer After Definitive Primary Treatment

“…68 Ga-PSMA-11 PET localized recurrent prostate cancer in 75% of patients; detection rates significantly increased with PSA level: 38% for , 0.5 ng/mL, 57% for 0.5 to , 1.0 ng/mL, 84% for 1.0 to , 2.0 ng/mL, 86% for 2.0 to , 5.0 ng/mL, and 97% for $ 5.0 ng/mL. PSMA PET resulted in changes in RT plans in 53% of patients undergoing definitive RT (101,102). In the salvage setting, Calais et al (103,104) showed that of 270 patients with a PSA level of , 1 ng/mL, use of 68 Ga-PSMA-11 PET/CT had a major impact on RT planning in 19%, justifying a randomized imaging trial of salvage RT.…”

The Injustice of Being Judged by the Errors of Others: The Tragic Tale of the Battle for PET Reimbursement

“…Three papers in the current issue of The Journal of Nuclear Medicine should add a further sad emoticon or 3 in the tragic tale of the battle fought between the PET community and HTA authorities (20)(21)(22). The papers by Hillner et al (20) and Gareen et al (21) were clearly motivated by an attempt to achieve reimbursement for PET with 18 F-fluoride for bone imaging, for which the NOPR had been collecting data under Medicare coverage with evidence development for nearly 7 years.…”

“…Under newer CMS coverage policy, PET with 68 Ga-PSMA-11 will be reimbursed for its labeled indication once this radiopharmaceutical is approved by the Food and Drug Administration, but that will provide no assurance of coverage by private insurers. Accordingly, the paper by Calais et al (22) was aimed at proactively addressing this potential coverage disparity between Medicare and other third-party payers, thereby avoiding coverage issues encountered to date in the United States with 68 Ga-DOTATATE and 18 F-fluciclovine. In all 3 studies, a large number of cases were analyzed within the NOPR frame-work, and changes in management plan were related to subsequent documentation of use of medical services and patient survival.…”