Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
GTx

Tracking Information
First Submitted Date  ICMJE March 25, 2011
First Posted Date  ICMJE March 30, 2011
Last Update Posted Date February 4, 2021
Study Start Date  ICMJE June 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2011)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2011)
  • 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 ]
  • To determine the time to castration in men with prostate cancer treated with GTx-758 [ Time Frame: 60 days ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: GTx-758
    comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
  • Drug: Lupron Depot
    comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
Study Arms  ICMJE
  • Experimental: GTX 758
    GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
    Intervention: Drug: GTx-758
  • Experimental: GTx-758
    GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
    Intervention: Drug: GTx-758
  • Active Comparator: Lupron Depot
    Luteinizing Hormone Releasing Hormone Agonist
    Intervention: Drug: Lupron Depot
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 29, 2011)
156
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01326312
Other Study ID Numbers  ICMJE G200705
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GTx
Study Sponsor  ICMJE GTx
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mitchell Steiner, MD GTx
PRS Account GTx
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP