Prostate cancer
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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 (
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is to determine whether CTC*s, PSA, PCA3, TMPRSS2-ERG and the NGMP are a reliable predictor of survival in men with CRPC receiving post-hormonal treatment (docetaxel, cabazitaxel, abiraterone or enzalutamide) or men with metastatic PCa receiving combination therapy (androgen deprivation therapy and docetaxel). The primary endpoint of this study is overall survival (OS). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint of this study will be biomarker response to treatment and biochemical and/or radiological recurrence of disease. | — |
Countries
Netherlands
Outcome results
None listed