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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01326312
Recruitment Status : Terminated (FDA Clinical Hold)
First Posted : March 30, 2011
Last Update Posted : April 24, 2014
Sponsor:
Information provided by (Responsible Party):
GTx

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: GTx-758 Drug: Lupron Depot Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: GTX 758
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
Drug: GTx-758
comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension

Experimental: GTx-758
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
Drug: GTx-758
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




Primary Outcome Measures :
  1. To determine the proportion of men who are castrate by Day 60 in those taking GTx 758 compared to those taking Lupron Depot. [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. To determine the proportion of men who are castrate by Day 60 and are maintained in the castrate range from Day 60 to Day 360/end of study. [ Time Frame: 12 months ]
  2. To determine the time to castration in men with prostate cancer treated with GTx-758 [ Time Frame: 60 days ]
  3. The change from baseline to Day 60 in free testosterone in GTx-758 treatment group compared to the Lupron treatment group will be assessed. [ Time Frame: 12 months ]


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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326312


Locations
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United States, Arizona
GTx Investigative Site
Phoenix, Arizona, United States, 85032
United States, California
GTx Investigative Site
La Mesa, California, United States, 91942
GTx Investigative Site
Los Angeles, California, United States, 90048
GTx Investigative Site
San Bernardino, California, United States, 92404
United States, Connecticut
GTx Investigative Site
Middlebury, Connecticut, United States, 06762
United States, Florida
GTx Investigative Site
Aventura, Florida, United States, 33180
GTx Investigative Site
Daytona Beach, Florida, United States, 32114
GTx Investigative Site
Wellington, Florida, United States, 33449
United States, Georgia
GTx Investigative Site
Marietta, Georgia, United States, 30060
United States, Illinois
GTx Investigative Site
Springfield, Illinois, United States, 62703
United States, Indiana
GTx Investigative Site
Fort Wayne, Indiana, United States, 46825
GTx Investigative Site
Indianapolis, Indiana, United States, 46260
GTx Investigative Site
Jeffersonville, Indiana, United States, 47130
United States, Maryland
GTx Investigative Site
Annapolis, Maryland, United States, 21401
GTx Investigative Site
Baltimore, Maryland, United States, 21204
United States, New Jersey
GTx Investigative Site
Brick, New Jersey, United States, 08724
GTx Investigative Site
Lawrenceville, New Jersey, United States, 08648
United States, New Mexico
GTx Investigative Site
Albuquerque, New Mexico, United States, 87109
United States, New York
GTx Investigative Site
Albany, New York, United States, 12208
GTx Investigative Site
Garden City, New York, United States, 11530
GTx Investigative Site
New York City, New York, United States, 10016
GTx Investigative Site
Oneida, New York, United States, 13421
GTx Investigative Site
Syracuse, New York, United States, 13210
United States, North Carolina
GTx Investigative Site
Chapel Hill, North Carolina, United States, 27514
GTx Investigative Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
GTx Investigative Site
Cincinnati, Ohio, United States, 45212
GTx Investigative Site
Columbus, Ohio, United States, 43220
United States, Pennsylvania
GTx Investigative Site
Bala Cynwyd, Pennsylvania, United States, 19004
GTx Investigative Site
Lancaster, Pennsylvania, United States, 17606
GTx Investigative Site
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
GTx Investigative Site
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
GTx Investigative Site
Memphis, Tennessee, United States, 38117
GTx Investigative Site
Nashville, Tennessee, United States, 37209
United States, Texas
GTx Investigative Site
Arlington, Texas, United States, 76017
GTx Investigative Site
Houston, Texas, United States, 77030
GTx Investigative Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
GTx
Investigators
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Study Director: Mitchell Steiner, MD GTx
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Responsible Party: GTx
ClinicalTrials.gov Identifier: NCT01326312    
Other Study ID Numbers: G200705
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: April 24, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents