Prostate cancer and prostatic diseases · 2025
Using patient-reported outcomes from the PROCLAIM trial to assess the impact of universal germline genetic testing for prostate cancer patients.
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Shore Neal D, Pieczonka Christopher M, Heron Sean, Gazi Mukaram, Cahn David J, Belkoff Laurence H, Berger Aaron D, Mazzarella Brian, Veys Joseph, Morris David, Bevan-Thomas Richard, Engelman Alexander, Dato Paul, Wise David R, Hardwick Mary Kay, Aradhya Kerry W, Heald Brandie, Nussbaum Robert L, Hatchell Kathryn E, Bucknor Brianna, Esplin Edward D, Nielsen Sarah M
Аннотация
BACKGROUND: Although germline genetic testing can inform medical management for patients with prostate cancer (PCa), data are limited regarding patient-reported outcomes (PROs) after germline genetic testing for PCa. Recall and comprehension of germline genetic testing results, uptake of post-test clinical recommendations, and psychological impact of germline genetic testing among patients with PCa were evaluated.
METHODS: This is a secondary analysis of data from the PROCLAIM trial. PROs were analyzed overall and by germline genetic testing results. Differences between groups were determined by two-tailed Fisher's exact test with significance set at p < 0.05.
RESULTS: Among 494 patients with informative survey responses, 60% and 71% accurately recalled and interpreted their germline genetic testing results, respectively, with the highest rates among patients with negative results and the lowest among those with variant of uncertain significance-only (VUS) results. Among 42/55 (76%) patients with positive results for whom clinicians made germline genetic testing-informed recommendations, 39 (93%) completed or planned to complete >1 clinical recommendation. Conversely, no further recommendations were made for 160/221 (72%) and 211/218 (97%) patients with VUS and negative results, respectively. However, 57% (213/371) of these patients indicated that they or their family members intended to pursue clinical management strategies that were not recommended by their clinicians. Of the patients who responded to the survey, >90% of patients reported no post-germline genetic testing increase in their level of concern for themselves or their family members.
CONCLUSION: germline genetic testing for patients with PCa did not cause appreciable psychological harm to the tested patients. Furthermore, patients with positive results had a high uptake of clinician-recommended management strategies. Of note, there were inconsistencies in the understanding of VUS results, with some clinicians making recommendations not warranted by personal/family history; conversely, some patients pursued management strategies not recommended by their clinicians. This suggests that educational efforts are needed in the communication of germline genetic testing results and clinical recommendations to patients.
METHODS: This is a secondary analysis of data from the PROCLAIM trial. PROs were analyzed overall and by germline genetic testing results. Differences between groups were determined by two-tailed Fisher's exact test with significance set at p < 0.05.
RESULTS: Among 494 patients with informative survey responses, 60% and 71% accurately recalled and interpreted their germline genetic testing results, respectively, with the highest rates among patients with negative results and the lowest among those with variant of uncertain significance-only (VUS) results. Among 42/55 (76%) patients with positive results for whom clinicians made germline genetic testing-informed recommendations, 39 (93%) completed or planned to complete >1 clinical recommendation. Conversely, no further recommendations were made for 160/221 (72%) and 211/218 (97%) patients with VUS and negative results, respectively. However, 57% (213/371) of these patients indicated that they or their family members intended to pursue clinical management strategies that were not recommended by their clinicians. Of the patients who responded to the survey, >90% of patients reported no post-germline genetic testing increase in their level of concern for themselves or their family members.
CONCLUSION: germline genetic testing for patients with PCa did not cause appreciable psychological harm to the tested patients. Furthermore, patients with positive results had a high uptake of clinician-recommended management strategies. Of note, there were inconsistencies in the understanding of VUS results, with some clinicians making recommendations not warranted by personal/family history; conversely, some patients pursued management strategies not recommended by their clinicians. This suggests that educational efforts are needed in the communication of germline genetic testing results and clinical recommendations to patients.