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

Not yet recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: androgen deprivation therapy only; Drug: Darolutamide in addition to androgen deprivation therapy

• Registration Number: NCT06435702
• Lead Sponsor: Peking University Third Hospital

Brief 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.

Detailed Description

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. The study evaluates the efficacy of immediate adjuvant ADT with darotarolimide in patients with positive lymph nodes after radical prostatectomy for prostate cancer, using time to achieve CRPC as the primary study endpoint. OS will be examined in all patients after the primary study endpoint is achieved and will serve as the key secondary study endpoint. It is planned to enroll 108 patients with positive lymph nodes after radical prostatectomy for prostate cancer. It is divided into a screening period, a treatment period and a follow-up period. Patients will enter the screening period from the time they sign the informed consent form, and those who have been evaluated and qualified in the screening period will be entered into the study. Patients eligible for enrollment will receive 2 years of ADT treatment or ADT treatment + darotarotide adjuvant therapy with or without combination radiotherapy at the investigator's discretion.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-26
• Study First Submitted QC: 2024-05-26
• Last Update Submitted: 2024-05-26
• Study First Posted: 2024-05-30
• Last Update Posted: 2024-05-30
• Study Start: 2024-06-01
• Primary Completion: 2026-07-01
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 108

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
androgen deprivation therapy only	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.
Darolutamide in addition to androgen deprivation therapy	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 type, frequency, and dose were determined by the investigator.

Primary Outcome Measures

Name	Time	Method
Time to CRPC	Time from initiation to the occurrence of PSA progression or imaging progression, whichever occurs first.	castrate resistant prostate cancer

Secondary Outcome Measures

Name	Time	Method
MFS	Time to metastasis or death confirmed from enrollment imaging, whichever occurred first	metastasis-free survival
rPFS	Time from initiation to imaging progression or death from any cause, whichever occurs first	radiography Progression-Free-Survival
PSA-PFS	Time from initiation to PSA progression or death, whichever occurs first	radiography Progression-Free-Survival

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China