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

Prostate Cancer Clinical Trial

— GTx758  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01326312
• Other study ID #: G200705
• Status: Terminated
• Phase: Phase 2
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: February 2021
• Source: GTx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 159
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• GTx-758 1000mg
comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
• Lupron Depot
comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
• GTx-758 2000mg
comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension

Locations

Country	Name	City	State
United States	GTx Investigative Site	Albany	New York
United States	GTx Investigative Site	Albuquerque	New Mexico
United States	GTx Investigative Site	Annapolis	Maryland
United States	GTx Investigative Site	Arlington	Texas
United States	GTx Investigative Site	Aventura	Florida
United States	GTx Investigative Site	Bala-Cynwyd	Pennsylvania
United States	GTx Investigative Site	Baltimore	Maryland
United States	GTx Investigative Site	Brick	New Jersey
United States	GTx Investigative Site	Chapel Hill	North Carolina
United States	GTx Investigative Site	Cincinnati	Ohio
United States	GTx Investigative Site	Columbus	Ohio
United States	GTx Investigative Site	Daytona Beach	Florida
United States	GTx Investigative Site	Fort Wayne	Indiana
United States	GTx Investigative Site	Garden City	New York
United States	GTx Investigative Site	Houston	Texas
United States	GTx Investigative Site	Indianapolis	Indiana
United States	GTx Investigative Site	Jeffersonville	Indiana
United States	GTx Investigative Site	La Mesa	California
United States	GTx Investigative Site	Lancaster	Pennsylvania
United States	GTx Investigative Site	Lawrenceville	New Jersey
United States	GTx Investigative Site	Los Angeles	California
United States	GTx Investigative Site	Marietta	Georgia
United States	GTx Investigative Site	Memphis	Tennessee
United States	GTx Investigative Site	Middlebury	Connecticut
United States	GTx Investigative Site	Myrtle Beach	South Carolina
United States	GTx Investigative Site	Nashville	Tennessee
United States	GTx Investigative Site	New York	New York
United States	GTx Investigative Site	Oneida	New York
United States	GTx Investigative Site	Phoenix	Arizona
United States	GTx Investigative Site	Pittsburgh	Pennsylvania
United States	GTx Investigative Site	Raleigh	North Carolina
United States	GTx Investigative Site	San Antonio	Texas
United States	GTx Investigative Site	San Bernardino	California
United States	GTx Investigative Site	Springfield	Illinois
United States	GTx Investigative Site	Syracuse	New York
United States	GTx Investigative Site	Wellington	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GTx

Country where clinical trial is conducted

United States, 

Outcome

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