Dynamics of Androgen Receptor Genomics and Transcriptomics After Neoadjuvant Androgen Ablation (NCT03297385) | Clinical Trial Compass
CompletedPhase 2
Dynamics of Androgen Receptor Genomics and Transcriptomics After Neoadjuvant Androgen Ablation
50 participantsStarted 2014-08-28
Plain-language summary
Rationale: Understanding the mechanisms of enzalutamide as an androgen receptor inhibitor in early prostate cancer could lead to improved patient selection for treatment.
Objective: To study the effects of enzalutamide on surgical margin status and AR / DNA interaction and gene expression.
Intervention : Men with localized prostate cancer will undergo an additional set of targeted tumor biopsies and will be subsequently treated with 3 months of enzalutamide. The prostatectomy specimen will be additionally sampled, ex vivo.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Men over 18 years of age.
. clinically non-metastasized prostate cancer, tumor that can be imaged (TRUS or MRI) in order to allow for accurate preoperative biopsies.
. Gleason score 7-10
. written informed consent
. WHO performance 0-1
Exclusion criteria
. A history of seizures.
. Clinically nodal metastases.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effects of enzalutamide on tumor downstaging
Timeframe: From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
2
Genetic and transcriptional changes caused by enzalutamide
Timeframe: From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).