In this article
FDA Approval of Enzalutamide for Prostate Cancer
The FDA has authorized enzalutamide for the treatment of non-metastatic castration-sensitive prostate cancer in cases of biochemical recurrence.
The Food and Drug Administration approved enzalutamide (Xtandi, Astellas Pharma US, Inc.) for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) on November 16, 2023.
EMBARK Clinical Trial Overview and Study Design
The effectiveness was assessed in EMBARK (NCT02319837), a randomized, controlled clinical study involving 1068 patients with non-metastatic castration-sensitive prostate cancer and high-risk biochemical recurrence. All patients had undergone radical prostatectomy and/or radiation with curative intent before, had a PSA doubling time of 9 months or less, and were not eligible for salvage radiotherapy when they joined the study. Participants were randomly assigned in a 1:1:1 ratio to receive either enzalutamide 160 mg once daily together with leuprolide in a blinded manner, enzalutamide 160 mg once daily as a single agent in an open-label manner, or a blinded placebo once daily along with leuprolide.
Metastasis-Free Survival and Treatment Efficacy
The primary outcome studied in the study was metastasis-free survival (MFS), evaluated by an impartial central review, comparing enzalutamide with leuprolide to placebo plus leuprolide. Additional efficacy outcome measures were the median failure-free survival (MFS) for enzalutamide monotherapy compared to placebo + leuprolide and overall survival (OS).
Enzalutamide plus leuprolide showed a statistically significant improvement in metastasis-free survival compared to placebo plus leuprolide, with a hazard ratio of 0.42 and a p-value of less than 0.0001. Enzalutamide monotherapy showed a statistically significant improvement in metastasis-free survival compared to placebo plus leuprolide, with a hazard ratio of 0.63 (95% CI: 0.46, 0.87; p-value = 0.0049). During the MFS analysis, the OS data were incomplete, showing a 12% mortality rate in the total population.
Common Side Effects and Adverse Reactions
Common side effects (≥ 20% incidence) in individuals treated with enzalutamide in combination with leuprolide were hot flush, musculoskeletal pain, weariness, fall, and bleeding. Common side effects of enzalutamide monotherapy include weariness, gynecomastia, musculoskeletal pain, breast tenderness, hot flush, and bleeding.
Recommended Dosage and Treatment Guidelines
The suggested enzalutamide dosage is 160 mg taken orally once a day, with or without food, until illness progression or unacceptable toxicity. Enzalutamide can be given with or without a GnRH analog. Enzalutamide medication may be stopped if PSA levels are below 0.2 ng/mL after 36 weeks of therapy. Treatment can be restarted when PSA levels reach > 2.0 ng/mL for individuals who underwent radical prostatectomy or ≥ 5.0 ng/mL for those who have primary radiation therapy.
How CancerFax Helps
CancerFax is a specialist cancer access and patient-navigation platform. We help patients and families understand their options, organise medical records, coordinate hospital communication, and support cross-border treatment planning where appropriate.
We help collect and organise reports, scans, pathology, biomarker results, and treatment history for structured case review.
We communicate with hospitals or trial teams to assess whether a case may be suitable for further screening.
We support appointment coordination, document submission, translation, and direct communication with international departments.
For international patients, we help with practical coordination — travel planning, hospital admission guidance, and local support.
If this option is not suitable, we help explore other relevant treatments, clinical trials, or advanced care pathways.
From inquiry through to follow-up, our coordinators provide a single point of contact for the family.
CancerFax does not guarantee treatment access, eligibility, or clinical outcome. Our role is to help patients access accurate information, structured review, and appropriate specialist pathways.
About Susan Hau
Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy. Hau's expertise lies in cancer cell biolo…
✓ Reviewed for medical accuracy by the CancerFax review panel.
Medical Disclaimer
This article is for educational purposes only and should not replace medical advice, diagnosis, or treatment from a qualified oncology specialist. Every patient's case is different. Treatment decisions should always be made after a review of complete medical records by the treating medical team.
Treatment availability, eligibility, timelines, and access can change. Any clinical trial participation depends on detailed review and approval by the trial hospital or investigator.