Status:
RECRUITING
A Phase II Neoadjuvant Study of Darolutamide Plus ADT in Men With Localized Prostate Cancer
Lead Sponsor:
Peking University First Hospital
Collaborating Sponsors:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The First Affiliated Hospital of Air Force Medicial University
Conditions:
Prostate Cancer
Eligibility:
MALE
18-75 years
Phase:
PHASE2
Brief Summary
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 therapi...
Eligibility Criteria
Inclusion
- Male ≥18 years of age.
- Able to Sign informed consent form independently.
- Non-metastatic adenocarcinoma of the prostate.
- 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.
- Subjects with pelvic lymph node involvement(N1) can be included.
- Candidate for radical prostatectomy with or without pelvic lymph node dissection as per the investigator.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Subjects must have normal organ and marrow function as defined below:
- 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.
Exclusion
- Prostate cancer with neuroendocrine differentiation or small cell features
- Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.
- History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer.
- Subjects who are planning bilateral orchidectomy during the treatment period of the study.
- Intolerable with darolutamide or ADT treatment.
- Candidates of other clinical trials.
- Any prior malignancy within 5 years.
- Complications include significant cardiovascular disease, active infection, astrointestinal disorders, or any other complications that in the opinion of the investigator.
- Any condition that in the opinion of the investigator would preclude participation in this study.
Key Trial Info
Start Date :
August 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT06029036
Start Date
August 5 2023
End Date
July 31 2026
Last Update
December 12 2023
Active Locations (1)
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1
Peking University First Hospital
Beijing, China