Evaluation and Effectiveness of Clinical Trials with Hormone Therapy in the Treatment of Prostate Cancer

Background: Prostate cancer is currently the most common malignant tumour in men. Research on hormone therapy advances is necessary because, unfortunately, some tumours are not organ-confined. Objective: To review and analyse the current state of evidence regarding clinical trials with neoadjuvant or adjuvant hormone therapy for prostate cancer and determine the contribution of these trials to the clinical practice. Methods: A critical systematic analysis of hormone therapy clinical trials for prostate cancer in the American Society of Clinical Oncology (ASCO) 2022 official database was carried out and following the Cochrane Handbook for Systematic Reviews of Interventions, a meta-analysis of random effects and standard mean descriptive statistics were performed. Groups: Group A = Neoadjuvant (n = 53) clinical trials and Group B = Adjuvant (n = 73) clinical hormone therapy. Variables: Phase of the trial, modality of primary treatment, investigated intervention or drug, molecular targets, trial length, sponsors and collaborators, country/countries of trial development, estimated enrolment, assignment of patients, intervention and masking model, trial purpose, related articles, the average number of studied patients, and conclusive results in clinical practice. Results: A total of 7.15% of the studies were in phase I, 14.28% between phase I-phase II, 52.38% in phase II, 0.23% between phase II-phase III and 23.80% in phase III. In the neoadjuvant group, enzalutamide and abiraterone were more frequently used, the androgen receptor was more frequently investigated as a molecular target. In the adjuvant group, abiraterone and prednisone were more frequently used and the androgen receptor and cytochrome P450 were more frequently investigated. The mean number of articles related to each trial was 5.26 (SD 3.15, 1-10). In 47.27% of the published articles directly related to the trials, the investigated treatment was superior to the standard treatment. Adjuvant investigated drugs showed more superiority (52.22%) than neoadjuvant drugs (41.33%). Conclusions: Only 41.33% of neoadjuvant studies and 52.22% of adjuvant studies show conclusive results of superiority for the proposed therapeutic strategies. About a third of related scientific publications that transfer the results to clinical practice did not report conclusive results for either neoadjuvant (32%) or adjuvant (37.78%) therapy.

Automated summary

Clinical trials on hormone therapy for prostate cancer show varying levels of uncertainty. Only about half of the trials demonstrate superiority in the proposed treatment strategies, and a substantial portion of related scientific publications do not report conclusive results.