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A Study to Evaluate the Safety, Tolerability and Efficacy of a Liproca® Depot Injection in Patients With Prostate Cancer

NCT03348527 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2020-12-21

No results posted yet for this study

Summary

A Single Blind, Two-Stage Dose Finding Study to Evaluate the Safety, Tolerability and Efficacy of a Single Liproca® Depot Injection into the Prostate in Patients with Localized Prostate Cancer,Assigned to Active Surveillance who are at High Risk for Disease Progression (followed by an Open Label Extension with a Repeat Injection (Optional))

Conditions

Interventions

DRUG

2-Hydroxyflutamide Depot

Liproca® Depot is a depot formulation containing a bioresorbable, controlled-release,formulation of the nonsteroidal antiandrogen 2-hydroxyflutamide

Sponsors & Collaborators

  • CMX Research

    collaborator OTHER

  • Lidds AB

    lead INDUSTRY

Principal Investigators

  • Richard Casey, MD · CMX Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-12
Primary Completion
2020-10-30
Completion
2020-11-30

Countries

  • Canada
  • Finland
  • Lithuania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03348527 on ClinicalTrials.gov