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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

Phase 2
45 Years
80 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

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

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

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.

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the proportion of men who are castrate by Day 60 in those taking GTx 758 compared to those taking Lupron Depot.

Outcome Time Frame:

60 days

Safety Issue:


Principal Investigator

Ronald Morton, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

October 2012

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



GTx Investigative Site Phoenix, Arizona  85032
GTx Investigative Site La Mesa, California  91942
GTx Investigative Site Middlebury, Connecticut  06762
GTx Investigative Site Aventura, Florida  33180
GTx Investigative Site Marietta, Georgia  30060
GTx Investigative Site Springfield, Illinois  62703
GTx Investigative Site Fort Wayne, Indiana  46825
GTx Investigative Site Annapolis, Maryland  21401
GTx Investigative Site Brick, New Jersey  08724
GTx Investigative Site Albuquerque, New Mexico  87109
GTx Investigative Site Albany, New York  12208
GTx Investigative Site Chapel Hill, North Carolina  27514
GTx Investigative Site Cincinnati, Ohio  45212
GTx Investigative Site Bala Cynwyd, Pennsylvania  19004
GTx Investigative Site Myrtle Beach, South Carolina  29572
GTx Investigative Site Memphis, Tennessee  38117
GTx Investigative Site Arlington, Texas  76017