Efficacy and Safety of Darolutamide Combined With ADT in High-risk/Very High-risk Localized Prostate Cancer

Launched by THE AFFILIATED NANJING DRUM TOWER HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL · Feb 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called Darolutamide when combined with hormone therapy (Androgen-Deprivation Therapy) for men with high-risk localized prostate cancer. The goal is to see if this combination therapy can help shrink the cancer before surgery, which is called radical prostatectomy. The trial is currently recruiting participants aged between 18 and 75 who have been diagnosed with prostate cancer that has not spread to other parts of the body and meet specific criteria indicating they have a more aggressive form of the disease.

To be eligible for this trial, participants must have certain characteristics, such as a high Gleason score (a way to grade prostate cancer), a specific level of prostate-specific antigen (PSA), or advanced tumor staging seen on imaging tests. Participants can expect to receive treatment for 24 weeks, and they will need to provide informed consent, meaning they understand the study and agree to participate. It’s important to note that certain health conditions and previous treatments may exclude individuals from participating in the trial. Overall, this study aims to explore promising new treatment options for men facing significant challenges with prostate cancer.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients must be ≥ 18 and ≤75 years of age；
• • 2. All patients must have a histologically or cytologically diagnosis of prostate cancer，without distant metastasis, and suitable for radical prostatectomy；
• • 3. All patients meet at least one of the following criteria：
• • 1. multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ T3；
• • 2. Gleason score of primary tumor ≥ 8；
• • 3. prostate specific antigen (PSA) ≥20 ng/ml； d) Radiographic assessment of regional lymph node metastases (N1)；
• • 4. Eastern Cooperative Oncology Group (ECOG) physical condition score 0- 1；
• • 5. Patients must have adequate organ function： hematologic function：within 28 days prior to registration as evidenced by: white blood cell (WBC) ≥ 4.0 × 109 / L, platelets≥ 100 × 109 / L, hemoglobin ≥ 9 g / dL and international normalized ratio (INR) \< 1.5； renal function：within 28 days prior to registration, as evidenced by serum creatinine ≤2×ULN； hepatic function: within 28 days prior to registration, as evidenced by: total bilirubin (TBIL)≤1.5 x upper limit of normal (ULN),and SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN；
• • 6. Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol.
• • 7. Patients of childbearing potential must be willing to take high-efficiency contraceptive measures during the study period and within 120 days after the last dose of treatment.
• Exclusion Criteria:
• • 1. Patients with prostate having neuroendocrine, small cell, or sarcoma-like features are not eligible.
• • 2. Patients with low-risk and medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: multiparameter MRI or PSMA PET / CT shows clinical staging of primary tumor \< T3, Gleason score of primary tumor \< 8, and prostate specific antigen (PSA)。
• • 3. Patients with clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases are not eligible.（any M1）。
• • 4. Patients who have previously received androgen deprivation therapy (medical or surgical) more than 3 months or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy are not eligible
• • 5. Patients with severe or uncontrolled concurrent infections are not eligible。
• • 6. Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months prior to registration.
• • 7. Patients must not have uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
• • 8. Patients must not have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.
• • 9. The patient is mentally ill, mentally disabled or incapable of giving informed consent