Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer (GTx758)

June 20, 2023 updated by: GTx

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Prostate cancer is one of the most frequently diagnosed noncutaneous cancers among men in the US and is the second most common cause of cancer deaths. Patients with advanced prostate cancer undergo androgen deprivation therapy (ADT), by either LHRH agonists, LHRH antagonists, DES and other nonselective estrogens, or by bilateral orchiectomy. ADT by LHRH agonists, LHRH antagonists, or bilateral orchiectomy not only reduces testosterone, but also substantially lowers estrogen levels as estrogen is derived from the aromatization of testosterone. ADT-induced estrogen deficiency causes significant side effects which include hot flushes, gynecomastia, bone loss, decreases in bone quality and strength, osteoporosis and life-threatening fractures, adverse lipid changes, increase in body fat composition, and higher cardiovascular disease and myocardial infarction, and depression and other mood changes.

GTx-758 is a nonsteroidal selective ER agonist that suppresses LH secretion by the pituitary by feedback inhibition of the hypothalamic-pituitary-gonadal axis to induce castrate levels of testosterone. However, because it is a selective ER agonist, GTx-758 may maintain bone, does not induce hot flushes, avoids adverse lipid changes and body fat composition changes, and does not have the acute testosterone surge that are associated with other forms of ADT.

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 2

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
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • GTx Investigative Site
    • California
      • La Mesa, California, United States, 91942
        • GTx Investigative Site
      • Los Angeles, California, United States, 90048
        • GTx Investigative Site
      • San Bernardino, California, United States, 92404
        • GTx Investigative Site
    • Connecticut
      • Middlebury, Connecticut, United States, 06762
        • GTx Investigative Site
    • Florida
      • Aventura, Florida, United States, 33180
        • GTx Investigative Site
      • Daytona Beach, Florida, United States, 32114
        • GTx Investigative Site
      • Wellington, Florida, United States, 33449
        • GTx Investigative Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • GTx Investigative Site
    • Illinois
      • Springfield, Illinois, United States, 62703
        • GTx Investigative Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • GTx Investigative Site
      • Indianapolis, Indiana, United States, 46260
        • GTx Investigative Site
      • Jeffersonville, Indiana, United States, 47130
        • GTx Investigative Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • GTx Investigative Site
      • Baltimore, Maryland, United States, 21204
        • GTx Investigative Site
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • GTx Investigative Site
      • Lawrenceville, New Jersey, United States, 08648
        • GTx Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • GTx Investigative Site
    • New York
      • Albany, New York, United States, 12208
        • GTx Investigative Site
      • Garden City, New York, United States, 11530
        • GTx Investigative Site
      • New York, New York, United States, 10016
        • GTx Investigative Site
      • Oneida, New York, United States, 13421
        • GTx Investigative Site
      • Syracuse, New York, United States, 13210
        • GTx Investigative Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • GTx Investigative Site
      • Raleigh, North Carolina, United States, 27607
        • GTx Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • GTx Investigative Site
      • Columbus, Ohio, United States, 43220
        • GTx Investigative Site
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • GTx Investigative Site
      • Lancaster, Pennsylvania, United States, 17606
        • GTx Investigative Site
      • Pittsburgh, Pennsylvania, United States, 15232
        • GTx Investigative Site
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • GTx Investigative Site
    • Tennessee
      • Memphis, Tennessee, United States, 38117
        • GTx Investigative Site
      • Nashville, Tennessee, United States, 37209
        • GTx Investigative Site
    • Texas
      • Arlington, Texas, United States, 76017
        • GTx Investigative Site
      • Houston, Texas, United States, 77030
        • GTx Investigative Site
      • San Antonio, Texas, United States, 78229
        • GTx Investigative Site

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

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. be between age 45 and 80 years of age
  2. be able to communicate effectively with study personnel
  3. ECOG is < or = 2
  4. screening serum total testosterone> or = 150ng/dL
  5. have prostate cancer, confirmed by pathology report
  6. have not been treated with androgen deprivation therapy(chemical or surgical
  7. have a clinical indication for the initiation of androgen deprivation therapy
  8. give written informed consent prior to any study specific procedures
  9. subject must agree to use acceptable methods of contraception

Exclusion Criteria:

  1. known hypersensitivity or allergy to estrogen or estrogen like drugs
  2. 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
  3. history of abnormal blood clotting,Factor V Leiden clotting disorder, thrombotic disease
  4. have ALT or AST above 2 times the upper normal limit
  5. have alkaline phosphatase greater than 3 times UNL and/or bilirubin levels above 2mg/dL at baseline
  6. patients cannot have brain or spinal cord metastases
  7. patients cannot have or be at risk for spinal cord compression from bone metastases
  8. received an investigational drug within a period of 90 days prior to enrollment in the study
  9. received the study medication previously
  10. currently taking testosterone, testosterone-like agents, or antiandrogens including 5-alpha reductase inhibitors within 4 weeks of randomization
  11. currently taking Saw Palmetto or PC-SPES (the subject may be considered for randomization after a 4 week washout period prior to randomization)
  12. have taken diethylstilbestrol or other estrogen products within the previous 12 months prior to randomization
  13. have taken body building or fertility supplements within 4 weeks of admission into the study (steroids and steroid like supplements)
  14. 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
  15. 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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GTx- 758 1000mg
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
Drug: GTx-758 2000mg
comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
Experimental: GTx-758 2000mg
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
Drug: GTx-758 1000mg
comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
Active Comparator: Lupron Depot
Luteinizing Hormone Releasing Hormone Agonist
Drug: Lupron Depot
comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Who Are Castrate by Day 60
Time Frame: 60 days
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Are Castrate by Day 60 and Maintained Castrate Range From Day 60 to Day 360/End of Study.
Time Frame: 12 months
12 months
Time to Castration in Participants With Prostate Cancer
Time Frame: 60 days
Median time to castration was summarized using the Kaplan-Meier method.
60 days

Collaborators and Investigators

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

Sponsor

GTx

Investigators

  • Study Director: Mitchell Steiner, MD, GTx

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

June 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 25, 2011

First Submitted That Met QC Criteria

March 29, 2011

First Posted (Estimated)

March 30, 2011

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G200705

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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