The Impact of Medication Timing Adjustment on the Effect of Novel Hormonal Therapy
NCT Number: NCT06505278
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Prostate Cancer
Interventions: DRUG: Receive Abiraterone plus prednisone/Enzalutamide/Apalutamide/Rezvilutamide in the evening
Sponsor: Sun Yat-sen University
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-12
Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China

Summary:
The purpose of this study is to assess the impact of medication timing adjustment on the effect of novel hormonal therapy (NHT) agents in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The half of the patients will receive NHT agents in the morning, and the other half will receive NHT agents in the evening.

Primary Outcome Measures: PSA response rate defiend as the proportion of participants whose prostate specific antigen (PSA) decreases by more than 90% from baseline after three months of treatment, PSA is a critical indicator for assessing the efficacy of prostate cancer treatment; typically, a lower PSA value suggests better therapeutic outcomes. A second PSA measurement is confirmed after 3 weeks from week 12., Baseline and Week 12
Secondary Outcome Measures: Circulating tumor cell (CTC) clearance rate defiend as the proportion testing negative for circulating tumor cell (CTC) at week 12 in patients with a baseline CTC count of ≥1, CTC are tumor cells that enter the bloodstream and are associated with the metastasis of tumors. Typically, a lower CTC count is indicative of better therapeutic efficacy., Baseline and Week 12|Clinical benefit rate (CBR) defiend as the proportion of patients comfirming partial response (PR), complete response (CR), or stable disease (SD)., Clinical benefit refers to participants achieving PR, CR, or SD., Through study completion, an average of 18 months|Objective response rate (ORR) defiend as the proportion of participants confirming partial response (PR) or complete response (CR), Objective response refers to participants achieving PR or CR, which would be confirmed 4 weeks later., Through study completion, an average of 18 months|Duration of relief defiend from the first assessment of complete response (CR) or partial response (PR) until the detection of disease progression (PD), Duration of relief represents the length of time the tumor remains reduced under this treatment regimen., From CR or PR to PD, up to 18 months|Time to achieve objective relief defiend from randomization until achieving complete response (CR) or partial response (PR)., Time to achieve objective relief is an important indicator of therapeutic efficacy., From start of treatment to CR or PR, up to 18 months|Time to PSA progression defiend the time from detection of PSA nadir to PSA progression, PSA progression refers to PSA\>1ng/ml, with at least a one-week interval between PSA measurement and two consecutive increases of\>50% compared to the baseline value., From start of treatment to PSA progression, up to 18 months|Radiographic progression-free survival (rPFS) defiend from randomization until radiographic progression according to RECIST 1.1 criteria, rPFS refers to the time from randomization to radiographic progression defined as tumor progression assessed by CT, MRI, or ECT according to RECIST 1.1 criteria, which is an important indicator for treatment efficacy., From start of treatment to radiographic progression, up to 18 months|Overall survival defined from randomization until death from any cause., Time to death refers to the time from randomization to death from any cause, which is a crucial indicator for treatment efficacy., From start of treatment to death from any cause, up to 18 months|Treatment emerged adverse event (TEAE), Treatment emerged adverse event would be assessed by NCI-CTCAE 5.0., Throughout the entire study period，an average of 18 months