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Clinical Trial VICCURO1450

Title

PROSPER: A Multinational, Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Enzalutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer

Principal Investigator(s)

David Penson

Details

  • Protocol No. VICCURO1450
  • Open Date: 08/13/2014
  • Staging: Phase III
  • Age Group: Adults
  • Scope: International
  • Objective: To determine the efficacy of enzalutamide compared with placebo as assessed by metastasis-free survival (MFS).
  • Disease Sites: Prostate
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Enzalutamide; MDV3100
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02003924
  • Secondary Protocol No: MDV3100-14

Description

None Provided.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Male
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
• Ongoing androgen deprivation therapy with a GnRH agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
• Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;
• Progressive disease on androgen deprivation therapy at enrollment;
• PSA and the screening PSA assessed by the central laboratory (central PSA) should be ≥ 2 µg/L (2 ng/mL:
• PSA doubling time ≤ 10 months;
• No prior or present evidence of metastatic disease;
• Asymptomatic prostate cancer;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Estimated life expectancy ≥ 12 months.
Exclusion Criteria:
• Prior cytotoxic chemotherapy;
• Use of hormonal therapy or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) or use of an investigational agent within 4 weeks of randomization;
• Known or suspected brain metastasis or active leptomeningeal disease;
• History of another invasive cancer within 3 years of randomization;
• Absolute neutrophil count < 1000/μL, platelet count < 100,000/μL, or hemoglobin < 10 g/dL (6.2 mmol/L) at screening;
• Total bilirubin ≥ 1.5 times the upper limit of normal;
• Creatinine > 2 mg/dL (177 µmol/L) at screening;
• Albumin < 3.0 g/dL (30 g/L) at screening;
• History of seizure or any condition that may predispose to seizure;
• Clinically significant cardiovascular disease;
• Gastrointestinal disorder affecting absorption;
• Major surgery within 4 weeks of randomization;
• Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;
• Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.