Dynamics of Androgen Receptor Genomics and Transcriptomics After Neoadjuvant Androgen Ablation

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Collaborator: Astellas Pharma Inc
• Treatments: Androgens; Ascorbic Acid; Estrogens, Conjugated (USP); Methyltestosterone

Criteria

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.