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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Darolutamide in addition to androgen deprivation therapy; Drug: androgen deprivation therapy only

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.

• Study Type: Observational
• Enrollment (Estimated): 108

Contacts and Locations

• Study Contact: Name: Shudong Zhang, MD; Phone Number: +86 010-82266699; Email: bysy@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
      • Contact: Shudong Zhang, MD; Phone Number: +86 010-82266699; Email: bysy@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population consisted of patients with non-metastatic prostate cancer who underwent radical prostatectomy with positive pathologic lymph nodes

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to CRPC	castrate resistant prostate cancer	Time from initiation to the occurrence of PSA progression or imaging progression, whichever occurs first.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Bayer

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: May 26, 2024
• First Submitted That Met QC Criteria: May 26, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 26, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Prostate Cancer; Radical Prostatectomy; Lymph Node-positive
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protective Agents; Estrogens; Micronutrients; Vitamins; Antioxidants; Anabolic Agents; Ascorbic Acid; Androgens; Methyltestosterone; Estrogens, Conjugated (USP)
• Other Study ID Numbers: LM2023526

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No