Clinical trial NCT02268175
Conditions: Prostate Adenocarcinoma Prostate Cancer High Risk Prostate Cancer
Keywords: prostate adenocarcinoma advanced prostate cancer high risk prostate cancer
Sponsor: Dana-Farber Cancer Institute
Start date: 2014-10-01; Completion date: 2021-12-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief 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

Arms: arm 1: Participants will be randomized in a 2:1 ratio to neoadjuvant treatment (ARM 1) or (ARM 2).

Participants will receive the assigned study treatment per cycle

* Enzalutamide- Once daily at prespecified dose, orally
* Abiraterone Acetate- Once daily at prespecified dose, orally
* Prednisone-Once daily at prespecified dose, orally
* Leuprolide Acetate-Intermuscular injection at prespecified dose and duration arm 2: Participants will be randomized in a 2:1 ratio to neoadjuvant treatment (ARM 1) or (ARM 2).

Participants will receive the assigned study treatment per cycle.

* Enzalutamide- once daily at prespecified dose, orally
* Leuprolide Acetate- Intermuscular injection at prespecified dose and duration
Interventions: intervention 1: Enzalutamide intervention 2: Abiraterone Acetate intervention 3: Prednisone intervention 4: Leuprolide Acetate
Intervention descriptions: intervention 1: 160 mg (four 40 mg capsules), oral, once daily, 28 days (4 weeks) 6 cycles maximum. Can be taken with or without food. intervention 2: 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. intervention 3: 5 mg, oral, once daily, 28 days (4 weeks) 6 cycles maximum.Take with food, preferred to be taken in the morning . intervention 4: Either 7.5 mg monthly or 22.5 mg every three months, Intramuscular, monthly or every three months.

Protocol documents:
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