Prostate Cancer Clinical Trial
— DARANAOfficial title:
Dynamics of Androgen Receptor Genomics and Transcriptomics After Neoadjuvant Androgen Ablation
Verified date | August 2017 |
Source | The Netherlands Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 1, 2017 |
Est. primary completion date | April 1, 2017 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Men over 18 years of age. 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: 1. A history of seizures. 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Netherlands Cancer Institute | Astellas Pharma Inc |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effects of enzalutamide on tumor downstaging | To study the effects of enzalutamide on surgical margin status and AR / DNA interaction and gene expression. | From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months). | |
Primary | Genetic and transcriptional changes caused by enzalutamide | The genetic and transcriptional changes caused by neoadjuvant androgen ablation by enzalutamide. | From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months). | |
Secondary | Clinical down-staging of enzalutamide pretreatment | To assess the effects of 3 months enzalutamide pretreatment on clinical down-staging | From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months). | |
Secondary | AR-chromatin binding alterations and Ki-67 expression | Study the correlation between AR-chromatin binding alterations and Ki-67 expression. | From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months). | |
Secondary | AR-dependant genes such as PSA, human kallikrein and PSMA | Compare the AR-chromatin binding with expression alterations of known AR-dependent genes such as PSA, human kallikrein and PSMA. | From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months). | |
Secondary | Gleason grading | Compare AR-chromatin binding patterns with Gleason grading. | From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months). | |
Secondary | Find associated genes in prostate tissue, using tissue microarray (TMA). | Find associated genes on TMA derived from prostatectomy specimens. | From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months). |
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