Efficacy and Safety Study of Toremifene Citrate for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer (TREAT2)

November 13, 2013 updated by: GTx

Phase III Randomized, Double-Blind, Placebo Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate 80 mg for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer on Androgen Deprivation Therapy

The purpose of this study is to determine whether Toremifene Citrate is effective in reducing the risk of bone fractures in men with prostate cancer who are on Androgen Deprivation Therapy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • give voluntary signed informed consent
  • have histologically documented prostate cancer
  • have been on ADT treatment for 6 months prior to randomization or intermittent LHRHa for preceeding 12 months
  • expected to continue LHRHa therapy uninterrupted for the next 12 months
  • have total testosterone levels less than 50 ng/dL
  • Have BMD of lumbar spine or femoral neck at or below the BMD thresholds
  • have a Zubrod performance status <or equal to 1
  • subject weight <300 lbs(<136 kg)
  • agree to complete a daily diary of medication intake
  • agree not to take excluded medications throughout the trial
  • agree to use an effective method of contraception
  • have adequate bone marrow, liver and renal functions

Exclusion Criteria:

  • Currently or previously exposed
  • within the past 5 years to intravenous bisphosphonates, strontium ranelate or Denosumab
  • for more than 3 years to oral bisphosphonates
  • within the last 45 days to PTH or PTH derivative, anabolic steroids or testosterone, SERMs, calcitonin, calcitriol or oral gluccorticoids
  • have any disease or condition that would preclude an accurate evaluation of radiographs of the thoracic or lumbar spine
  • have <8 evaluable vertebrae
  • have a BMD T score <-4 at the lumbar spine or total hip or femoral neck
  • have any history of other carcinomas within the last 5 years
  • Serum PSA > 5ng/mL at baseline under ADT
  • have Paget's disease, Cushing's disease, chronic hepatitis or cirrhosis or rheumatoid arthritis
  • have active uncontrolled systemic viral, bacterial or fungal infections
  • have a clinically significant concurrent illness or psychological, familial, sociological, geograhical or other condition that would not permit adequate follow-up and compliance
  • received treatment with other investigational agents within 30 days
  • taking finasteride, dutasteride, danazol or testosterone like substances
  • taking herbal medicines or dietary supplements
  • have a history of thromboembolic disease including DVT or pulmonary embolus
  • have a QTcF of > or equal to 450 msec or congenital or acquired QTc prolongation
  • have HIV
  • calcicum urolithiasis prohibiting the use of vitamin D

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To confirm the efficacy of toremifene 80mg compared with placebo in the reduction in the risk of new bone fracture occurrences in men with prostate cancer on androgen deprivation therapy as measured by semiquantitative assessment of vertebral fractures
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GTx

Collaborators

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

October 1, 2010

First Submitted That Met QC Criteria

October 1, 2010

First Posted (Estimate)

October 5, 2010

Study Record Updates

Last Update Posted (Estimate)

November 15, 2013

Last Update Submitted That Met QC Criteria

November 13, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G300213

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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