NCT02268175

Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate

A Phase II Randomized Study of Enzalutamide+Leuprolide Versus Enzalutamide+Leuprolide+Abiraterone Acetate+Prednisone as Neoadjuvant Therapy for HIgh-Risk Prostate Cancer Undergoing Prostatectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is comparing the effectiveness of enzalutamide with or without abiraterone acetate for men with high-risk, localized prostate cancer.

Detailed description

In this research study, the investigators are comparing the effectiveness of enzalutamide with or without abiraterone acetate for men with high-risk, localized prostate cancer. Abiraterone acetate with prednisone and enzalutamide are currently FDA-approved for use in the treatment of patients with metastatic castration-resistant prostate cancer, however they are investigational for the treatment of localized prostate cancer. Abiraterone acetate works by decreasing the production of male sex hormones, which cause prostate cancer growth. Enzalutamide works by blocking the effects of male sex hormones, which cause prostate cancer growth. The FDA (the U.S. Food and Drug Administration) has not approved the combination of enzalutamide and abiraterone acetate as neoadjuvant therapy for high risk prostate cancer undergoing prostatectomy but each drug has been approved for the treatment of more advanced prostate cancer. Participants will be randomized to one of two study arms. Randomization means that the participant is put into a group by chance. It is like flipping a coin. Neither participant nor the research doctor will choose what group participants are randomized to. The names of the study medications involved in this study are: * Enzalutamide * Abiraterone Acetate * Prednisone * Leuprolide Acetate

Conditions

• Prostate Adenocarcinoma
• Prostate Cancer
• High Risk Prostate Cancer

Interventions

Type	Name	Description
DRUG	Enzalutamide	160 mg (four 40 mg capsules), oral, once daily, 28 days (4 weeks) 6 cycles maximum. Can be taken with or without food.
DRUG	Abiraterone Acetate	1000 mg (four 250 mg tablets), oral, once daily, 28 days (4 weeks) 6 cycles maximum. No food should be consumed for at least two hours before the dose and for at least one hour after the dose.
DRUG	Prednisone	5 mg, oral, once daily, 28 days (4 weeks) 6 cycles maximum.Take with food, preferred to be taken in the morning .
DRUG	Leuprolide Acetate	Either 7.5 mg monthly or 22.5 mg every three months, Intramuscular, monthly or every three months.

Timeline

• Start date: 2014-10-01
• Primary completion: 2018-01-01
• Completion: 2021-12-01
• First posted: 2014-10-20
• Last updated: 2022-04-19
• Results posted: 2019-10-08

Locations

4 sites across 1 country: United States