Limitations
comorbidity
SECONDARY
This study has limitations. First, it is a secondary subgroup analysis, and therefore these results are hypothesis-generating and should be evaluated in a new cohort study. Second, our observation of the significant factors associated with the shorter time to PSA failure may not be applicable in treatment settings outside the one used in this study. Therefore, the question remains whether these factors are maintained in the postoperative settings. Third, it is important to recognize that the high ECOG performance status observed in this cohort, which was a requirement for inclusion in the initial trial design, may limit the generalizability of our findings to populations with different performance status profiles. Fourth, it is important to acknowledge that the study cohort primarily consisted of non-Hispanic White men, which may limit the generalizability of our findings to more racially diverse populations. Fifth, the patient’s level of comorbidity may affect the survival benefit from the treatment intensification, and therefore future randomized clinical trials should consider prerandomization stratification by comorbidity level in addition to the high-risk group defined by our study.