NCT01214291

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

November 15, 2013

Status Verified

November 1, 2013

Enrollment Period

6 months

First QC Date

October 1, 2010

Last Update Submit

November 13, 2013

Conditions

Risk of Bone Fracture Occurrences

Keywords

fracturesprostate cancerandrogen deprivation therapy

Outcome Measures

Primary Outcomes (1)

  • 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

    36 months

Interventions

ToremifeneDRUG

Toremifene 80mg daily

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Fractures, BoneProstatic Neoplasms

Interventions

Toremifene

Condition Hierarchy (Ancestors)

Wounds and InjuriesGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TamoxifenStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Mitchell Steiner, MD

    GTx

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2010

First Posted

October 5, 2010

Study Start

March 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

November 15, 2013

Record last verified: 2013-11

Locations

US(1)