Patient-reported outcomes of rezvilutamide versus bicalutamide in combination with androgen deprivation therapy in high-volume metastatic hormone-sensitive prostate cancer patients (CHART): a randomized, phase 3 study.

The randomized phase 3 CHART trial (NCT03520478) revealed that rezvilutamide (REZ) plus androgen deprivation therapy (ADT) in high-volume, metastatic, hormone-sensitive prostate cancer (mHSPC) significantly enhanced radiographic progression-free and overall survival than bicalutamide (BIC)-ADT. Accordingly, we examined patient-reported outcomes (PROs) results, which were exploratory endpoints in the CHART trial. The patients were randomly allocated to receive REZ-ADT or BIC-ADT in a 1:1 ratio. The PROs were evaluated with the Brief Pain Inventory-Short Form (BPI-SF) and the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaires. Both study groups displayed comparable baseline pain scores and functional status. Patients administered REZ-ADT had an extended time to progression of worst pain intensity in comparison to those treated with BIC-ADT (25th percentile, 9.2 [95% CI 7.4-16.6] vs. 6.4 months [95% CI 5.5-8.3]; HR 0.75 [95% CI 0.57-0.97]; p = 0.026). Similarly, patients received REZ-ADT exhibited a delayed time to progression of pain interference in comparison to those receiving BIC-ADT (25th percentile, 20.2 [95% CI 12.9-31.3] vs. 10.2 months [95% CI 7.4-11.1]; HR 0.70 [95% CI 0.52-0.93]; p = 0.015). Additionally, the REZ-ADT group demonstrated a prolonged delay in the deterioration of the total score on the FACT-P questionnaire (25th percentile, 12.8 [95% CI 7.4-20.3] vs. 6.0 months [95% CI 4.6-9.2]; HR 0.66 [95% CI 0.50-0.86]; p = 0.002), as well as most of the FACT-P subscale scores, in comparison to the BIC-ADT group. In conclusion, REZ-ADT is superior to BIC-ADT regarding the pain alleviation and enhancement of functional scales for high-volume mHSPC.