Dynamics of Androgen Receptor Genomics and Transcriptomics After Neoadjuvant Androgen Ablation
NCT ID: NCT03297385
Last Updated: 2017-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2014-08-28
2017-04-01
Brief Summary
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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.
Detailed Description
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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
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Prostatectomy after enzalutamide
This is a single-arm study. Patients will have biopsies, after which they will receive enzalutamide for 3 months.
After 3 months they will have a prostatectomy.
Enzalutamide
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.
Interventions
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Enzalutamide
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. clinically non-metastasized prostate cancer, tumor that can be imaged (TRUS or MRI) in order to allow for accurate preoperative biopsies.
3. Gleason score 7-10
4. written informed consent
5. WHO performance 0-1
Exclusion Criteria
2. Clinically nodal metastases.
3. Prostatitis or urinary tract infection.
4. Androgen ablative therapy within 6 weeks of inclusion (including 5 alpha-reductase inhibitors).
5. Tumor of the prostate that can not be visualized by TRUS or MRI.
18 Years
MALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
The Netherlands Cancer Institute
OTHER
Responsible Party
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References
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Zhang M, Moreno-Rodriguez T, Quigley DA. Why ARNT Prostate Tumors Responding to Enzalutamide? Cancer Discov. 2022 Sep 2;12(9):2017-2019. doi: 10.1158/2159-8290.CD-22-0702.
Other Identifiers
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N14DAR
Identifier Type: -
Identifier Source: org_study_id