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

Sponsor

GTx (Industry)

Overall Status

Terminated

CT.gov ID

NCT01326312

Collaborator

(none)

156

Enrollment

Locations

Arms

Duration (Months)

4.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 Drug: GTx-758	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.

Study Design

Study Type:

Interventional

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 :

Jun 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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. [12 months]
To determine the time to castration in men with prostate cancer treated with GTx-758 [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. [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GTx Investigative Site	Phoenix	Arizona	United States	85032
2	GTx Investigative Site	La Mesa	California	United States	91942
3	GTx Investigative Site	Los Angeles	California	United States	90048
4	GTx Investigative Site	San Bernardino	California	United States	92404
5	GTx Investigative Site	Middlebury	Connecticut	United States	06762
6	GTx Investigative Site	Aventura	Florida	United States	33180
7	GTx Investigative Site	Daytona Beach	Florida	United States	32114
8	GTx Investigative Site	Wellington	Florida	United States	33449
9	GTx Investigative Site	Marietta	Georgia	United States	30060
10	GTx Investigative Site	Springfield	Illinois	United States	62703
11	GTx Investigative Site	Fort Wayne	Indiana	United States	46825
12	GTx Investigative Site	Indianapolis	Indiana	United States	46260
13	GTx Investigative Site	Jeffersonville	Indiana	United States	47130
14	GTx Investigative Site	Annapolis	Maryland	United States	21401
15	GTx Investigative Site	Baltimore	Maryland	United States	21204
16	GTx Investigative Site	Brick	New Jersey	United States	08724
17	GTx Investigative Site	Lawrenceville	New Jersey	United States	08648
18	GTx Investigative Site	Albuquerque	New Mexico	United States	87109
19	GTx Investigative Site	Albany	New York	United States	12208
20	GTx Investigative Site	Garden City	New York	United States	11530
21	GTx Investigative Site	New York	New York	United States	10016
22	GTx Investigative Site	Oneida	New York	United States	13421
23	GTx Investigative Site	Syracuse	New York	United States	13210
24	GTx Investigative Site	Chapel Hill	North Carolina	United States	27514
25	GTx Investigative Site	Raleigh	North Carolina	United States	27607
26	GTx Investigative Site	Cincinnati	Ohio	United States	45212
27	GTx Investigative Site	Columbus	Ohio	United States	43220
28	GTx Investigative Site	Bala-Cynwyd	Pennsylvania	United States	19004
29	GTx Investigative Site	Lancaster	Pennsylvania	United States	17606
30	GTx Investigative Site	Pittsburgh	Pennsylvania	United States	15232
31	GTx Investigative Site	Myrtle Beach	South Carolina	United States	29572
32	GTx Investigative Site	Memphis	Tennessee	United States	38117
33	GTx Investigative Site	Nashville	Tennessee	United States	37209
34	GTx Investigative Site	Arlington	Texas	United States	76017
35	GTx Investigative Site	Houston	Texas	United States	77030
36	GTx Investigative Site	San Antonio	Texas	United States	78229

Sponsors and Collaborators

Investigators

Study Director: Mitchell Steiner, MD, GTx

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GTx

ClinicalTrials.gov Identifier:

NCT01326312

Other Study ID Numbers:

G200705

First Posted:

Mar 30, 2011

Last Update Posted:

Feb 4, 2021

Last Verified:

Feb 1, 2021

Additional relevant MeSH terms:

Prostatic Neoplasms

Leuprolide

Study Results

No Results Posted as of Feb 4, 2021