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

NCT06435702 | Not Yet Recruiting FDA Drug

• 1 other identifier: LM2023526
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Lymph Node-positive; Prostate Cancer; Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• Time to CRPC

  castrate resistant prostate cancer

  Time from initiation to the occurrence of PSA progression or imaging progression, whichever occurs first.

Secondary Outcomes (3)

• MFS

  Time to metastasis or death confirmed from enrollment imaging, whichever occurred first

• rPFS

  Time from initiation to imaging progression or death from any cause, whichever occurs first

• PSA-PFS

  Time from initiation to PSA progression or death, whichever occurs first

Study Arms (2)

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

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

Interventions

Darolutamide in addition to androgen deprivation therapy DRUG

Darolutamide 600mg twice daily. The ADT regimen was either a gonadotropin-releasing hormone analog agonist or a gonadotropin-releasing hormone antagonist.The ADT administration

Darolutamide in addition to androgen deprivation therapy

androgen deprivation therapy only DRUG

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.

androgen deprivation therapy only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \. 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.

You may not qualify if:

• Patients will not be enrolled if they have any of the following:
• have histologic features of neuroendocrine differentiation or small cell carcinoma;
• 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
• Inability to tolerate Darotamine or ADT treatment;
• persons who are allergic or have a known history of allergy to darotarolimide or ADT;

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Bayer: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

darolutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Shudong Zhang, MD

CONTACT

+86 010-82266699; bysy@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: May 30, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

CN (1)