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

Launched by SUN YAT-SEN UNIVERSITY · Jul 10, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how the timing of taking a new type of hormone therapy affects its effectiveness in treating prostate cancer that has spread to other parts of the body. The study will involve two groups of men with metastatic hormone-sensitive prostate cancer (mHSPC). One group will take the medication in the morning, while the other will take it in the evening. By comparing the outcomes of these two groups, researchers hope to find the best time for patients to take their medication for improved results.

To participate in this trial, men aged 18 to 75 who have been diagnosed with prostate cancer and have not yet received hormone therapy or chemotherapy may be eligible. They should be able to tolerate treatment and have a life expectancy of at least 12 weeks. Participants will need to sign a consent form to join the study. This trial is not yet recruiting, so interested individuals should stay tuned for updates on when they can enroll. Overall, this study aims to find ways to enhance the effectiveness of treatment for prostate cancer, which could lead to better outcomes for patients.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.