The Impact of Medication Timing Adjustment on the Effect of Novel Hormonal Therapy

  • 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

info icon Patients who voluntarily participate in the study and have signed a written informed consent form (ICF);

info icon Male patients aged 18 to 75 years (inclusive) at the time of signing the ICF;

info icon Histologically or cytologically confirmed prostate cancer, without prior novel hormonal therapy (NHT) or chemotherapy;

info icon 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;

info icon Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1;

info icon Normal routine blood count and liver and kidney functions, expected to tolerate treatment for mHSPC;

info icon Expected survival period ≥ 12 weeks.

info icon Agreement to sign the ICF.

info icon Minimum age: 18

info icon Patients who do not meet the inclusion criteria;

info icon Patients currently receiving other systemic anticancer treatments (such as chemotherapy and/or immunotherapy);

info icon Patients who have undergone organ transplantation within the past three months;

info icon 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;

info icon Patients with severe life-threatening diseases;

info icon Patients who have not signed the ICF;

info icon 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.

NCT06505278

Clinic Location Investigator Distance RECRUITING STATUS Contact