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

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Sep 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach for men with high-risk localized prostate cancer, which is a type of cancer that hasn’t spread to other parts of the body but has certain aggressive features. The researchers want to see if adding a new hormone therapy called darolutamide to standard hormone therapy (ADT) can reduce the size of the tumor before surgery. The goal is to measure how effective this combination treatment is in lowering tumor volume after surgery.

To participate in the trial, you must be a man aged 18 or older, diagnosed with non-metastatic prostate cancer, and meet specific high-risk criteria, such as having a high Gleason score or a high PSA level. Participants will receive the treatment and then undergo surgery to remove the prostate and possibly nearby lymph nodes. Throughout the study, your health will be closely monitored, and you'll receive support from the research team. This trial is currently recruiting participants, so if you meet the criteria and are interested, you can discuss it with your doctor for more information.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Male ≥18 years of age.
• • 2. Able to Sign informed consent form independently.
• • 3. Non-metastatic adenocarcinoma of the prostate.
• • 4. 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.
• • 5. Subjects with pelvic lymph node involvement(N1) can be included.
• • 6. Candidate for radical prostatectomy with or without pelvic lymph node dissection as per the investigator.
• • 7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
• 8. 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 Criteria:
• • 1. Prostate cancer with neuroendocrine differentiation or small cell features
• • 2. Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.
• • 3. History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer.
• • 4. Subjects who are planning bilateral orchidectomy during the treatment period of the study.
• • 5. Intolerable with darolutamide or ADT treatment.
• • 6. Candidates of other clinical trials.
• • 7. Any prior malignancy within 5 years.
• • 8. Complications include significant cardiovascular disease, active infection, astrointestinal disorders, or any other complications that in the opinion of the investigator.
• • 9. Any condition that in the opinion of the investigator would preclude participation in this study.