- Not Yet Recruiting
- Treatment
- Interventional
- Randomized
- Drug
- PHASE2
- Sun Yat-sen University
- 18 - 75 Years
Study Purpose
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.
Intervention
Drug : Receive Abiraterone plus prednisone/Enzalutamide/Apalutamide/Rezvilutamide in the evening
Eligibility Requirements
Patients who voluntarily participate in the study and have signed a written informed consent form (ICF);
Male patients aged 18 to 75 years (inclusive) at the time of signing the ICF;
Histologically or cytologically confirmed prostate cancer, without prior novel hormonal therapy (NHT) or chemotherapy;
Assessed as having metastatic hormone-sensitive prostate cancer (mHSPC), defined as: histologically or cytologically confirmed prostate cancer with distant metastases (beyond regional lymph nodes) detected by bone scan, MRI, CT, PET/CT, or pathological examination, and who have not received hormonal therapy or chemotherapy;
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1;
Normal routine blood count and liver and kidney functions, expected to tolerate treatment for mHSPC;
Expected survival period ≥ 12 weeks.
Agreement to sign the ICF.
Minimum age: 18
Patients who do not meet the inclusion criteria;
Patients currently receiving other systemic anticancer treatments (such as chemotherapy and/or immunotherapy);
Patients who have undergone organ transplantation within the past three months;
Patients with active, known, or suspected autoimmune diseases; or those testing positive for hepatitis B virus, hepatitis C virus, or HIV indicating acute or chronic infection;
Patients with severe life-threatening diseases;
Patients who have not signed the ICF;
Other conditions deemed by the researchers to make the patient unsuitable for participation in the trial.
Recruiting status
Not Yet Recruiting
Estimated enrollment
70
Study start date
Aug 31, 2024
Study end date
Dec 31, 2025
Last updated
Mar 23, 2025
Primary purpose
Treatment
Design
Interventional
Intervention
Drug
Study phase
PHASE2
Allocation
Randomized
Sponsor:
Sun Yat-sen University
Collaborator:
N/A
Investigator:
Yonghong Li, M.D.
Publications
Mottet N, Cornford P, Vanden Bergh RCN, et al. EAU-EANM-ESTRO-ESUR-ISUP_SIOG guidelines on prostate cancer. (2023).
Websites
N/A
NCT06505278
Clinic | Location | Investigator | Distance | RECRUITING STATUS | Contact |
---|