Prognostic Value of the Intermediate-risk Feature in Men with Favorable Intermediate-risk Prostate Cancer: Implications for Active Surveillance.

BACKGROUND

Guidelines suggest that active surveillance (AS) may be considered for select patients with favorable intermediate-risk (fIR) prostate cancer.

OBJECTIVE

To compare the outcomes between fIR prostate cancer patients included by Gleason score (GS) or prostate-specific antigen (PSA). Most patients are classified with fIR disease due to either a 3 + 4 = 7 GS (fIR-GS) or a PSA level of 10-20 ng/ml (fIR-PSA). Previous research suggests that inclusion by GS 7 may be associated with worse outcomes.

DESIGN SETTING AND PARTICIPANTS

We conducted a retrospective cohort study of US veterans diagnosed with fIR prostate cancer from 2001 to 2015.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

We compared the incidence of metastatic disease, prostate cancer-specific mortality (PCSM), all-cause mortality (ACM), and receipt of definitive treatment between fIR-PSA and fIR-GS patients managed with AS. Outcomes were compared with those of a previously published cohort of patients with unfavorable intermediate-risk disease using cumulative incidence function and Gray's test for statistical significance.

RESULTS AND LIMITATIONS

The cohort included 663 men; 404 had fIR-GS (61%) and 249 fIR-PSA (39%). There was no evidence of difference in the incidence of metastatic disease (8.6% vs 5.8%,  = 0.77), receipt of definitive treatment (77.6% vs 81.5%,  = 0.43), PCSM (5.7% vs 2.5%,  = 0.274), and ACM (16.8% vs 19.1%,  = 0.14) between the fIR-PSA and fIR-GS groups at 10 yr. On multivariate regression, unfavorable intermediate-risk disease was associated with higher rates of metastatic disease, PCSM, and ACM. Limitations included varying surveillance protocols.

CONCLUSIONS

There is no evidence of difference in oncological and survival outcomes between men with fIR-PSA and fIR-GS prostate cancer undergoing AS. Thus, presence of GS 7 disease alone should not exclude patients from consideration of AS. Shared decision-making should be utilized to optimize management for each patient.

PATIENT SUMMARY

In this report, we compared the outcomes of men with favorable intermediate-risk prostate cancer in the Veterans Health Administration. We found no significant difference between survival and oncological outcomes.