Dynamics of Androgen Receptor genomics and transcriptomics after neoadjuvant androgen ablation (DARANA)
Phase 2
- Conditions
- 10038597prostate cancerprostate carcinoma
- Registration Number
- NL-OMON40287
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Objective:<br /><br>1. to evaluate whether 3 months neoadjuvant androgen ablation with enzalutamide<br /><br>can reduce the surgicial positive margin rate of men with non-metastasized<br /><br>prostate cancer.<br /><br>2. Analyse the effects of short term (3 months) enzalutamide on distinct<br /><br>AR-chromatin binding patterns in correlation with tissue proliferation in<br /><br>normal prostate tissue and prostate cancer.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Objective(s):<br /><br>= To assess the effects of 3 months enzalutamide pretreatment on down-staging<br /><br>= Study the correlation between AR-chromatin binding alterations and Ki-67<br /><br>expression.<br /><br>= Compare the AR-chromatin binding with expression alterations of known<br /><br>AR-dependent genes such as PSA, human kallikrein and PSMA.<br /><br>= Compare AR-chromatin binding patterns with gleason grading.<br /><br>= Confirm findings of associated genes on TMA derived from prostatectomy<br /><br>specimens.<br /><br></p><br>