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
Darolutamide in addition to androgen deprivation therapyandrogen deprivation therapy only
Darolutamide in addition to androgen deprivation therapy: Darolutamide 600mg twice daily. The ADT regimen was either a gonadotropin-releasing hormone analog agonist or a gonadotropin-releasing hormone antagonist.The ADT administration
androgen deprivation therapy only: The ADT regimen was either a gonadotropin-releasing hormone analog agonist or a gonadotropin-releasing hormone antagonist.The ADT administration type, frequency, and dose were determined by the investigator.
Study summary
This study is an open, prospective, single-center observational clinical study to evaluate the efficacy and safety of immediate adjuvant ADT with darotarolimide in the treatment of patients with positive lymph nodes after radical prostatectomy for prostate cancer.
Eligibility
Sex
MALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Time to CRPC — Time from initiation to the occurrence of PSA progression or imaging progression, whichever occurs first. castrate resistant prostate cancer
Trial sites (1)
Facility
City
Region
Status
Peking University Third Hospital
Beijing
Beijing Municipality
More Peking University Third Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.