A Phase II Neoadjuvant Study of Darolutamide Plus ADT in Men With Localized Prostate Cancer

  • Recruiting
  • Treatment
  • Interventional
  • Drug
  • PHASE2
  • Peking University First Hospital
  • 18 - 75 Years


Study Purpose

Scientific Rationale: High risk localized prostate cancer (PCa) is associated with higher rates of biochemical recurrence, clinical recurrence, metastasis and PCa-specific death. Novel hormone therapies(NHT) have shown a significant survival advantage with respect to classical ADT in later stages of PCa and have already been investigated in neoadjuvant setting. PURPOSE: To assess antitumor effect by measuring pathological tumor volume with pathological downstaging following radical prostatectomy + pelvic lymph-node dissection (RP + PLND) for high-risk localized prostate cancer patients.

Intervention

Drug : Darolutamide+ADT


Eligibility Requirements

info icon Male ≥18 years of age.

info icon Able to Sign informed consent form independently.

info icon Non-metastatic adenocarcinoma of the prostate.

info icon Subjects must have as least one of the following features according to NCCN definition of high-risk: Gleason score ≥8, or PSA \>20ng/ml,or≥clinical T3a.

info icon Subjects with pelvic lymph node involvement(N1) can be included.

info icon Candidate for radical prostatectomy with or without pelvic lymph node dissection as per the investigator.

info icon Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

info icon Subjects must have normal organ and marrow function as defined below:

info icon Hemoglobin ≥ 9.0 g/dL;Absolute neutrophil count (ANC) ≥ 1,500/mcL; Platelets ≥ 100,000/mcL, independent of transfusions/growth factors within 3 months of treatment start; Serum potassium ≥ 3.5 mmol/L; Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN) (except in subjects with Gilbert's syndrome who have a total bilirubin \> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN;Serum albumin ≥ 3.0 g/dL;Serum creatinine \< 2.0 x ULN.

info icon Prostate cancer with neuroendocrine differentiation or small cell features

info icon Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.

info icon History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer.

info icon Subjects who are planning bilateral orchidectomy during the treatment period of the study.

info icon Intolerable with darolutamide or ADT treatment.

info icon Candidates of other clinical trials.

info icon Any prior malignancy within 5 years.

info icon Complications include significant cardiovascular disease, active infection, astrointestinal disorders, or any other complications that in the opinion of the investigator.

info icon Any condition that in the opinion of the investigator would preclude participation in this study.

Recruiting status

Recruiting

Estimated enrollment

53

 
Study start date

Aug 05, 2023

Study end date

Jul 31, 2026

Last updated

Mar 22, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Drug

Study phase

PHASE2

Allocation

Na

 

Sponsor:

Peking University First Hospital

Collaborator:

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

The First Affiliated Hospital of Air Force Medicial University

Investigator:

N/A

NCT06029036

Clinic Location Investigator Distance RECRUITING STATUS Contact