Back to resultsEfficacy and Safety Study of Toremifene Citrate for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer (TREAT2)
Primary Purpose
Risk of Bone Fracture Occurrences
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Toremifene
Sponsored by
About this trial
This is an interventional prevention trial for Risk of Bone Fracture Occurrences focused on measuring fractures, prostate cancer, androgen deprivation therapy
Eligibility Criteria
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
Sites / Locations
- VA Puget Sound
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01214291
First Posted
October 1, 2010
Last Updated
November 13, 2013
Sponsor
GTx
Collaborators
Ipsen
1. Study Identification
Unique Protocol Identification Number
NCT01214291
Brief Title
Efficacy and Safety Study of Toremifene Citrate for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer
Acronym
TREAT2
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Withdrawn
Why Stopped
cost of conducting the study and increased burden on the clinical trial professionals make it impossible for us to proceed with the development of the drug.
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GTx
Collaborators
Ipsen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Risk of Bone Fracture Occurrences
Keywords
fractures, prostate cancer, androgen deprivation therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Toremifene
Intervention Description
Toremifene 80mg daily
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Steiner, MD
Organizational Affiliation
GTx
Official's Role
Study Director
Facility Information:
Facility Name
VA Puget Sound
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Toremifene Citrate for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer
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