Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients (PLATO)

Pfizer

Status and phase: Completed; Phase 4

Conditions: Prostate Cancer

Treatments: Drug: Placebo for Enzalutamide; Drug: Enzalutamide; Drug: Abiraterone; Drug: Prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01995513

2013-000722-54 (EudraCT Number)

MDV3100-10

C3431013 (Other Identifier)

PLATO, C3431013 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.

Enrollment: 509 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men with metastatic castration-resistant prostate cancer
• Progressive disease on androgen deprivation therapy
• Patients must agree to continue androgen deprivation therapy with a GnRH agonist/antagonist throughout the study or have had a prior bilateral orchiectomy
• ECOG performance score ≤ 1
• Estimated life expectancy of ≥ 12 months

Exclusion criteria

• Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or enzalutamide for the treatment of prostate cancer
• Prior participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless the treatment was placebo)
• History of brain metastasis, active leptomeningeal disease or seizure
• Severe cardiovascular or hepatic disease
• Pituitary or adrenal dysfunction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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509 participants in 2 patient groups

Enzalutamide & Abiraterone/prednisone

Experimental group

Description:

Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with abiraterone (1000 mg) administered as four 250-mg tablets by mouth once daily and prednisone (10 mg) administered as one 5-mg tablet by mouth twice daily

Treatment:

Drug: Prednisone

Drug: Abiraterone

Drug: Enzalutamide

Enzalutamide placebo & Abiraterone/prednisone

Active Comparator group

Description:

Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with abiraterone (1000 mg) administered as four 250-mg tablets by mouth once daily and prednisone (10 mg) administered as one 5-mg tablet by mouth twice daily.

Treatment:

Drug: Prednisone

Drug: Abiraterone

Drug: Placebo for Enzalutamide