Status:
NOT_YET_RECRUITING
The Impact of Medication Timing Adjustment on the Effect of Novel Hormonal Therapy
Lead Sponsor:
Sun Yat-sen University
Conditions:
Prostate Cancer
Eligibility:
MALE
18-75 years
Phase:
PHASE2
Brief 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 (mH...
Detailed Description
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. ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06505278
Start Date
August 1 2024
End Date
December 1 2025
Last Update
August 5 2024
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060