NCT Number: NCT03297385
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.
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Notify Me18 year and older
Male
Interventional
Phase 2
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.
Study design: A phase II prospective single-arm analysis. With a power of 80% to detect an expected reduction in positive surgical margin rate from 34% to 17% the investigators will have to included 55 men. For the AR/DNA interaction patients will serve as there own control since biopsies will be taken before and after enzalutamide treatment.
Study population: Patients over 18 years of age with localized prostate cancer that are planned for prostatectomy.
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.
Main study parameters/endpoints: 1. The effects of neoadjuvant androgen ablation on tumor downstaging. 2. The genetic and transcriptional changes caused by neoadjuvant androgen ablation by enzalutamide.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Burden and risks: Patients will be submitted to an additional set of 4 tumor targeted biopsies under local anesthesia and antibiotic prophylaxis. This comprises a 5 minute intervention with an elevated (2%) risk of postbiopsy urinary tract infection. Additionally oral enzalutamide treatment for a period of 3 months will result in temporary signs of androgen ablation such as: hot flushes (20%), headache (12%), diarrhea (1%), and seizures (0.9%). Benefits: neoadjuvant enzalutamide treatment has been shown to result in tumor and prostate downsizing. Earlier neoadjuvant androgen ablation studies with other agents have shown a reduced positive surgical margin rate and reduced intraoperative blood loss
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Xtandi
Time frame: From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
To study the effects of enzalutamide on surgical margin status and AR / DNA interaction and gene expression.
Time frame: From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
The genetic and transcriptional changes caused by neoadjuvant androgen ablation by enzalutamide.
Time frame: From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
To assess the effects of 3 months enzalutamide pretreatment on clinical down-staging
Time frame: From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
Study the correlation between AR-chromatin binding alterations and Ki-67 expression.
Time frame: From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
Compare the AR-chromatin binding with expression alterations of known AR-dependent genes such as PSA, human kallikrein and PSMA.
Time frame: From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
Compare AR-chromatin binding patterns with Gleason grading.
Time frame: From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
Find associated genes on TMA derived from prostatectomy specimens.
The Netherlands Cancer Institute
Other
Acronym: DARANA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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