NCT01942837

Study of Enzalutamide in Patients With Castration-resistant Prostate Cancer

Phase II Trial of Enzalutamide for Castrate-resistant Prostate Cancer (CRPC) With Correlative Assessment of Androgen Receptor (AR) Signaling and Whole-exome and Transcriptome Sequencing

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating a drug called enzalutamide in metastatic castration resistant prostate cancer. Enzalutamide is already FDA approved for metastatic castration resistant prostate cancer after treatment with chemotherapy. The purpose of this study is to analyze features of tumor specimens sampled prior to therapy and at disease progression to determine why patients respond or stop responding to treatment with Enzalutamide. Prior chemotherapy is not a requirement of this trial.

Detailed description

After the screening procedures confirm that the patient is able to participate in the study, * The patient will have the first of two required prostate biopsies prior to starting study treatment. * The patient will be given a prescription for study drug and a study drug-dosing diary for each treatment cycle. Each treatment cycle lasts 28 days (4 weeks), during which time the patient will be taking the study drug once daily. The diary will also include special instructions for taking the study drug. The study drug (enzalutamide) should be taken orally (by mouth) at home. On Day 1 of each cycle (+/- 4 days), the following procedures will be performed in clinic: * A medical history. * A Physical examination * Performance status * Blood tests (2-3 tablespoons). * The patient will be asked about medications they are currently taking, including over-the counter medications, herbal remedies, vitamins, and supplements. * The patient will be asked about any disease-related symptoms they are experiencing. * The patient will receive a new supply and the medication diary will be reviewed. Every 12 weeks (+/-1 week) the following procedures will be performed in clinic: * Blood tests. A small sample of the patient's blood (about 1-2 tablespoons) will be collected. This blood will be collected for specialized laboratory tests. * A (CT) scan of the patient's chest and a CT or MRI scan of abdomen, and pelvis and a bone scan will be performed every 12 weeks (+/- 1 week) while the patient is on active treatment. If your baseline CT of the patient's chest does not show disease, the investigator may not asked for this to be repeated. End of Study Visit in clinic: * A medical history. * A physical examination * Performance status * Blood tests (2-3 tablespoons) * The patient will be asked about any disease-related symptoms If the patient completed at least 4 cycles of enzalutamide, the patient will undergo a second of two required biopsies.

Conditions

• Metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Enzalutamide	Enzalutamide, formerly known as MDV3100, is a rationally-designed second generation AR inhibitor which functions by blocking several steps in the AR signaling cascade. Enzalutamide competitively binds the AR with great potency. Additionally, enzalutamide inhibits nuclear translocation of activated AR and inhibits the association of activated AR with DNA.

Timeline

• Start date: 2013-09-13
• Primary completion: 2021-12-01
• Completion: 2022-09-30
• First posted: 2013-09-16
• Last updated: 2022-10-24
• Results posted: 2022-07-05

Locations

5 sites across 1 country: United States