prostate cancer prostate carcinoma
Conditions
Interventions
1. tumor directed prostate biopsies
2. 3 months of neoadjuvant enzalutamide treatment
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Men over 18 years of age. 2. non-metastasized prostate cancer, visible on transrectal ultrasound or MRI planned for prostatectomy 3. Gleason score 7-10 4. written informed consent 5. WHO performance 0-1
Exclusion criteria
Exclusion criteria: 1. A history of seizures 2. Clinically nodal metastases 3. Prostatitis or urinary tract infection Androgen ablative therapy within 6 weeks of inclusion (including 5 alpha-reductase inhibitors)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: 1. to evaluate whether 3 months neoadjuvant androgen ablation with enzalutamide can reduce the surgicial positive margin rate of men with non-metastasized prostate cancer. 2. Analyse the effects of short term (3 months) enzalutamide on distinct AR-chromatin binding patterns in correlation with tissue proliferation in normal prostate tissue and prostate cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective(s): = To assess the effects of 3 months enzalutamide pretreatment on down-staging = Study the correlation between AR-chromatin binding alterations and Ki-67 expression. = Compare the AR-chromatin binding with expression alterations of known AR-dependent genes such as PSA, human kallikrein and PSMA. = Compare AR-chromatin binding patterns with gleason grading. = Confirm findings of associated genes on TMA derived from prostatectomy specimens. | — |
Countries
Netherlands
Outcome results
None listed