A Trial of Androgen Deprivation, Docetaxel, and Enzalutamide for Metastatic Prostate Cancer (NCT03246347)
🩺 Plain-English Summary (8th-Grade Level)
This is a study with the combination of androgen deprivation therapy (ADT) and docetaxel with the addition of enzalutamide in the treatment of subjects with metastatic prostate cancer. The purpose of this study is to assess if ADT + docetaxel + enzalutamide is well tolerated and demonstrates improved efficacy compared to ADT + docetaxel.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (15 items) and avoid the listed exclusions (18 items).
Location: Levine Cancer Institute — Charlotte, North Carolina
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Personal history of seizure.
- Personal history of conditions that may predispose to seizure activity including cortical cerebrovascular accident or brain trauma.
- Known central nervous system metastases, including involvement of brain parenchyma and leptomeninges.
- Personal history of any condition that may impair absorption of enzalutamide.
- Prior or current therapy with ketoconazole, abiraterone, enzalutamide, apalutamide (ARN-509, JNJ-56021927), darolutamide (ODM-201, BAY1841788) or cytotoxic chemotherapy such as docetaxel, cabazitaxel, cyclophosphamide.
- Prior therapy with bicalutamide, nilutamide or flutamide within 14 days of enrollment.
- Within 28 days of major surgery and/or lack of recovery from prior surgical procedure or 14 days of palliative radiation prior to enrollment.
- Prior or current therapy with an investigational agent for metastatic prostate cancer.
- Known hypersensitivity to drugs formulated with polysorbate 80.
- Personal history of posterior reversible encephalopathy syndrome.
- CTCAE version 4.0 grade 2-4 peripheral sensory neuropathy.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Levine Cancer Institute — Charlotte, North Carolina
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.