Clinical evaluation of biomarkers as predictors of survival in metastatic prostate cancer patients - BOSS 2

niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 123 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

Trial is onging in other countries

•- 18 years or older and capacitated.
•- Patients with histological confirmed prostate adenocarcinoma who are commencing post-hormonal (docetaxel, cabazitaxel, abiraterone or enzalutamide) treatment will be included.
•1. These patients include castration-resistant prostate cancer (CRPC) patients with progression despite castrate levels of testosterone and hormonal treatment (<50 ng/ml). The castration-resistant status was defined as: either biological recurrence (two consecutive increases in the PSA level after the nadir, with a minimum 2 week interval between measurements) and/or radiological recurrence (new osseous lesions and/or new or enlarged soft tissue metastases) during hormonal treatment.
•2. Besides, patients with metastatic PCa and treated with the combination of androgen deprivation therapy and docetaxel chemotherapy will be included as well.;Protocol page 12

•The subject will be ineligible for study enrolment if the subject, clinician, or medical record reports:
•- Symptoms of urinary tract infection (including prostatitis) at the time of enrolment.
•- Baseline PSA level of <= 5,0
•- Eastern Cooperative Oncology Group performance status of > 2
•- Radiation or radionuclide therapy within 30 days of entry
•- History of other malignancies within the last 5 years.
•- Participation in a pharmaceutical or treatment-related clinical study or receipt of treatment for a prostate-related condition within the last six months of enrolment. Trials for non-prostate condition may be acceptable, with approval by the investigator.;Protocol page 13

发起方

niversitair Medisch Centrum Sint Radboud