Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy in Prostate Cancer Patients With Lymph Node-positive After Radical Prostatectomy: A Prospective Observational Cohort Study

Launched by PEKING UNIVERSITY THIRD HOSPITAL · May 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called darolutamide when given alongside hormone therapy for men with prostate cancer who have positive lymph nodes after surgery to remove their prostate. The goal is to see how well this combination treatment works and if it is safe for patients. This study will take place at a single center and is currently not recruiting participants.

To be eligible for this trial, men aged 18 to 80 who have been diagnosed with prostate cancer and have had surgery to remove their prostate can participate. They must have positive lymph nodes after surgery but no signs of cancer spreading to other parts of the body. Participants will need to provide their consent to join the study. Those who have had previous treatments for prostate cancer or have certain health conditions may not be able to take part. If you join this study, you can expect regular check-ups and monitoring to assess how well the treatment is working.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. patients voluntarily enrolled in the study and signed an informed consent form; 2. aged 18-80 years (including 18 and 80 years), male; 3. diagnosed with prostate adenocarcinoma by pathology or cytology; 4. Eastern Cooperative Oncology Group (ECOG) Physical Status (PS) score 0-1. 5. patients who have undergone radical prostatectomy (RP) and pelvic lymph node dissection (PLND) without non-regional lymph node metastasis, bone metastasis, or metastasis to other sites (e.g., visceral metastasis) as confirmed by conventional imaging (bone imaging, CT, or MRI) or PSMA PET/CT 6. have positive postoperative pathologic lymph nodes (pN1); 7. with their consent and have signed an informed consent form.
• Exclusion Criteria:
• * Patients will not be enrolled if they have any of the following:
• • 1. have histologic features of neuroendocrine differentiation or small cell carcinoma;
• • 2. have received prior treatment for prostate cancer: postoperative systemic therapy including ADT for \>3 months, conventional endocrine therapy (e.g., flutamide, bicalutamide) for \>3 months, novel endocrine therapy (e.g., dalotamide, abiraterone, abatacept, enzalutamide), chemotherapy (e.g., docetaxel), immunotherapy, and targeted therapies
• • 3. Inability to tolerate Darotamine or ADT treatment;
• • 4. persons who are allergic or have a known history of allergy to darotarolimide or ADT;
• • 5. other conditions that the investigator considers inappropriate for inclusion.