Study Stopped
FDA Clinical Hold
Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer
GTx758
Phase II, Open Label, Dose Finding Study of the Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer Compared to a Luteinizing Hormone Releasing Hormone Agonist
1 other identifier
interventional
159
1 country
36
Brief Summary
The purpose of this study is to determine whether GTx 758 is effective in achieving and maintaining castrate testosterone levels in men with advanced prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Jun 2011
Shorter than P25 for phase_2 prostate-cancer
36 active sites
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
March 25, 2011
CompletedFirst Posted
Study publicly available on registry
March 30, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
June 22, 2023
CompletedJune 22, 2023
February 1, 2021
1.5 years
March 25, 2011
May 22, 2023
June 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Are Castrate by Day 60
60 days
Secondary Outcomes (2)
Number of Participants Who Are Castrate by Day 60 and Maintained Castrate Range From Day 60 to Day 360/End of Study.
12 months
Time to Castration in Participants With Prostate Cancer
60 days
Study Arms (3)
GTx- 758 1000mg
EXPERIMENTALGTx-758/Experimental/ nonsteroidal selective ER alpha agonist
GTx-758 2000mg
EXPERIMENTALGTx-758/Experimental/ nonsteroidal selective ER alpha agonist
Lupron Depot
ACTIVE COMPARATORLuteinizing Hormone Releasing Hormone Agonist
Interventions
comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
Eligibility Criteria
You may qualify if:
- be between age 45 and 80 years of age
- be able to communicate effectively with study personnel
- ECOG is \< or = 2
- screening serum total testosterone\> or = 150ng/dL
- have prostate cancer, confirmed by pathology report
- have not been treated with androgen deprivation therapy(chemical or surgical
- have a clinical indication for the initiation of androgen deprivation therapy
- give written informed consent prior to any study specific procedures
- subject must agree to use acceptable methods of contraception
You may not qualify if:
- known hypersensitivity or allergy to estrogen or estrogen like drugs
- a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol
- history of abnormal blood clotting,Factor V Leiden clotting disorder, thrombotic disease
- have ALT or AST above 2 times the upper normal limit
- have alkaline phosphatase greater than 3 times UNL and/or bilirubin levels above 2mg/dL at baseline
- patients cannot have brain or spinal cord metastases
- patients cannot have or be at risk for spinal cord compression from bone metastases
- received an investigational drug within a period of 90 days prior to enrollment in the study
- received the study medication previously
- currently taking testosterone, testosterone-like agents, or antiandrogens including 5-alpha reductase inhibitors within 4 weeks of randomization
- currently taking Saw Palmetto or PC-SPES (the subject may be considered for randomization after a 4 week washout period prior to randomization)
- have taken diethylstilbestrol or other estrogen products within the previous 12 months prior to randomization
- have taken body building or fertility supplements within 4 weeks of admission into the study (steroids and steroid like supplements)
- have a history of cancer other than prostate cancer, superficial bladder cancer (with no recurrence in the last 5 years) and/or non-melanoma carcinoma of the skin
- QTcB\>480 msec, If the first QTcB reading exceeds 480msec two additional ECGs are to be performed separated at least 5 min apart, then take the average of the three QTcB or readings to determine if the subject satisfies the above criteria. If the average QYcB reading is \>480 msec then the subject is excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GTxlead
Study Sites (36)
GTx Investigative Site
Phoenix, Arizona, 85032, United States
GTx Investigative Site
La Mesa, California, 91942, United States
GTx Investigative Site
Los Angeles, California, 90048, United States
GTx Investigative Site
San Bernardino, California, 92404, United States
GTx Investigative Site
Middlebury, Connecticut, 06762, United States
GTx Investigative Site
Aventura, Florida, 33180, United States
GTx Investigative Site
Daytona Beach, Florida, 32114, United States
GTx Investigative Site
Wellington, Florida, 33449, United States
GTx Investigative Site
Marietta, Georgia, 30060, United States
GTx Investigative Site
Springfield, Illinois, 62703, United States
GTx Investigative Site
Fort Wayne, Indiana, 46825, United States
GTx Investigative Site
Indianapolis, Indiana, 46260, United States
GTx Investigative Site
Jeffersonville, Indiana, 47130, United States
GTx Investigative Site
Annapolis, Maryland, 21401, United States
GTx Investigative Site
Baltimore, Maryland, 21204, United States
GTx Investigative Site
Brick, New Jersey, 08724, United States
GTx Investigative Site
Lawrenceville, New Jersey, 08648, United States
GTx Investigative Site
Albuquerque, New Mexico, 87109, United States
GTx Investigative Site
Albany, New York, 12208, United States
GTx Investigative Site
Garden City, New York, 11530, United States
GTx Investigative Site
New York, New York, 10016, United States
GTx Investigative Site
Oneida, New York, 13421, United States
GTx Investigative Site
Syracuse, New York, 13210, United States
GTx Investigative Site
Chapel Hill, North Carolina, 27514, United States
GTx Investigative Site
Raleigh, North Carolina, 27607, United States
GTx Investigative Site
Cincinnati, Ohio, 45212, United States
GTx Investigative Site
Columbus, Ohio, 43220, United States
GTx Investigative Site
Bala-Cynwyd, Pennsylvania, 19004, United States
GTx Investigative Site
Lancaster, Pennsylvania, 17606, United States
GTx Investigative Site
Pittsburgh, Pennsylvania, 15232, United States
GTx Investigative Site
Myrtle Beach, South Carolina, 29572, United States
GTx Investigative Site
Memphis, Tennessee, 38117, United States
GTx Investigative Site
Nashville, Tennessee, 37209, United States
GTx Investigative Site
Arlington, Texas, 76017, United States
GTx Investigative Site
Houston, Texas, 77030, United States
GTx Investigative Site
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study terminated early
Results Point of Contact
- Title
- Mary Breitmeyer
- Organization
- Oncternal
Study Officials
- STUDY DIRECTOR
Mitchell Steiner, MD
GTx
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2011
First Posted
March 30, 2011
Study Start
June 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
June 22, 2023
Results First Posted
June 22, 2023
Record last verified: 2021-02