A Phase 2 interventional study of Receive Abiraterone plus prednisone/Enzalutamide/Apalutamide/Rezvilutamide in the evening in Prostate Cancer, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-05.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
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.
Metastatic hormone-sensitive prostate cancer (mHSPC) can be treated with androgen deprivation therapy (ADT) plus novel hormonal therapy (NHT) agents such as abiraterone, enzalutamide and apalutamide. However, after a period of treatment, patients inevitably develop resistance to hormonal therapy, progressing to metastatic castration-resistant prostate cancer (mCRPC). Once resistance occurs, treatment options are limited and the prognosis is poor. Therefore, enhancing the efficacy of hormonal therapy and delaying the onset of resistance is currently a focal point of research in advanced prostate cancer.
Androgens are a fundamental basis for the growth, proliferation, and metastasis of prostate cancer cells, exhibiting significant circadian rhythms in their synthesis and secretion. The synthesis of androgens and their products such as androstenedione (A4) and testosterone (T) accelerates in the early morning, peaks around 8:00 AM, then declines, reaching a nadir around 8:00 PM. NHT agents, such as abiraterone, primarily inhibit the synthesis of androgens by blocking the CYP17A1 enzyme, thereby aiming to suppress tumor growth. However, abiraterone is currently administered mainly on an empty stomach in the morning, when androgen and its metabolites have already peaked and been released into the bloodstream. Hence, inhibiting androgen synthesis at this time may not yield optimal effects.
Chronotherapy refers to the administration of therapy in alignment with the circadian rhythms of the patient, tumor, and drug to enhance therapeutic efficacy and reduce adverse reactions. In certain malignancies, research has been conducted to adjust the timing of drug administration based on these circadian characteristics, resulting in improved efficacy and reduced adverse reactions compared to traditional dosing schedules.
However, no study has explored the impact of different timing of NHT agents administration on the therapeutic efficacy and safety currently.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's planned enrollment of 70 is above the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
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Exclusion Criteria:
Participants receive Abiraterone plus prednisone/Enzalutamide/Apalutamide/Rezvilutamide between 10:00 pm and 12:00 pm.
Drug: Receive Abiraterone plus prednisone/Enzalutamide/Apalutamide/Rezvilutamide in the evening
Participants receive Abiraterone plus prednisone/Enzalutamide/Apalutamide/Rezvilutamide between 7:00 am and 9:00 am.
Participants receive Abiraterone plus prednisone/Enzalutamide/Apalutamide/Rezvilutamide between 10:00 pm and 12:00 pm in the evening.
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.
Time frame: Baseline and Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Throughout the entire study period，an average of 18 months
Plan to share: No
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