ClinicalTrials.Veeva

Menu

Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer (PROSPER)

Pfizer logo

Pfizer

Status and phase

Active, not recruiting
Phase 3

Conditions

Nonmetastatic Castration-Resistant Prostate Cancer
Prostate Cancer
Cancer of the Prostate

Treatments

Drug: Placebo
Drug: Enzalutamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02003924
C3431005 (Other Identifier)
2012-005665-12 (EudraCT Number)
MDV3100-14

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.

Enrollment

1,401 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 gonadotropin-releasing hormone (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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,401 participants in 2 patient groups

Placebo
Sham Comparator group
Description:
Sugar pill manufactured to mimic enzalutamide 40 mg capsule
Treatment:
Drug: Placebo
Enzalutamide
Experimental group
Description:
160 mg by mouth once daily
Treatment:
Drug: Enzalutamide

Trial documents
2

Trial contacts and locations

398

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems