Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer

Launched by XIJING HOSPITAL · Aug 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for men with high-risk prostate cancer. The researchers want to find out if using Darolutamide along with a standard treatment called androgen deprivation therapy (ADT) before surgery can help improve the chances of completely removing the cancer with no remaining traces. The study compares this combination treatment to ADT alone to see if it leads to better outcomes.

To participate in this trial, men aged 18 to 75 who have been diagnosed with prostate cancer and are eligible for surgery may qualify. They must have certain characteristics indicating their cancer is more aggressive, such as a higher Gleason score or elevated prostate-specific antigen (PSA) levels. Participants will undergo imaging tests before and after the treatment and will need to sign a consent form to show they understand the study details. If you or someone you know is interested in joining, it’s important to discuss it with a doctor to understand the potential benefits and risks involved.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Patients must be ≥ 18 and ≤75 years of age.
• • All patients must have a histologically or cytologically diagnosis of prostate cancer and must be eligible for radical prostatectomy.
• • Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤1.
• • All patients must complete mpMRI or 68Ga-PSMA PET / CT before and after neoadjuvant treatment.
• • All patients must undergo thorough tumor staging and meet one of the following criteria: 1. multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ cT2c or cN+or locally advanced, 2. Gleason score of primary tumor ≥ 8, 3. prostate specific antigen (PSA) ≥20 ng/ml.
• * Patients must have adequate organ function as defined by the following criteria(within 28 days prior to registration):
• • white blood cell (WBC) ≥ 4.0 × 109 / L platelets≥ 100 × 109 / L hemoglobin ≥ 9 g / dL international normalized ratio (INR) \< 1.5. total bilirubin (TBIL)≤1.5 x upper limit of normal (ULN) SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN serum creatinine ≤2×ULN
• • 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.
• Exclusion Criteria:
• • clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases.
• • Prior androgen deprivation therapy (medical or surgical) or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy.
• • severe or uncontrolled concurrent infections.
• • New York Heart Association Class III or IV congestive heart failure at the time of screening.
• • uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
• • Patients with mental illness, mental disability or inability to give informed consent are not eligible.
• • Patients 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.