Abstract
Serum IGF-1 levels in men with advanced prostate cancer treated with the ERα agonist, GTx-758
Journal of clinical oncology, v 31(6_suppl)
20 Feb 2013
Abstract
Abstract only
171
Background: The insulin pathway and, in particular, insulin-like growth factor-1 (IGF-1), has been implicated in the development of prostate cancer, and serum IGF-1 levels have been associated with advanced disease. GTx-758, an ERα agonist that is being evaluated for the treatment of advanced prostate cancer, reduces serum total testosterone (T) and free T and increases SHBG. Herein, we compare the effects of GTx-758 and leuprolide on serum IGF-1 levels in men with advanced prostate cancer treated with ADT. Methods: In a Phase II study (G200705), men with advanced prostate cancer (n=159) received 1000 mg or 2000 mg of GTx-758 daily or leuprolide. Serum samples were collected from all of the men in the study and serum IGF-1 levels (ng/ml) were analyzed by a reference laboratory. All p values describe the comparison of GTx-758 treatment groups to the leuprolide treated men. Results: Through day 90, in men receiving the 1000 mg and 2000 mg doses of GTx-758 , serum IGF-1 levels were decreased by more than 70 ng/ml (greater than 50%), while levels stayed constant or increased slightly in men on leuprolide (p<0.001). As a result of an increased risk of venous thromboembolic events (VTEs) at these higher doses of GTx-758, the trial was stopped prior to its completion, and not all of the men in the study reached the 90 day treatment date (92 men reached that date). Conclusions: In men with advanced prostate cancer, the ERα agonist, GTx-758, can decrease the active form of testosterone, serum free T, to significantly lower levels than leuprolide. Patients receiving GTx-758 experienced a significant decrease in serum IGF-1. Since changes in insulin metabolism are involved in regulating prostate cancer as well as bone and systemic metabolism, the observed decreases in IGF-1 could be significant. A Phase II clinical trial utilizing lower doses of GTx-758 (G200712) is currently ongoing to determine if similar effects can be observed with a lower rate of VTEs. Clinical trial information: NCT01326312.
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Details
- Title
- Serum IGF-1 levels in men with advanced prostate cancer treated with the ERα agonist, GTx-758
- Creators
- Evan Y. Yu - Fred Hutch Cancer CenterMarc Gittelman - Aventura Hospital and Medical CenterThomas E. Keane - Medical University of South CarolinaRonald Tutrone - Chesapeake Urology AssociatesLaurence Belkoff - Urology AssociatesRobert Given - Urology of VirginiaJoel Bass - AMP of NY - Urology, Syracuse, NYFranklin Chu - San Bernardino Urological Association, San Bernardino, CAMike Gambla - Columbus Oncology and Hematology AssociatesFranklin Gaylis - Genesis HealthCareJames Bailen - Urology of IndianaRobert H. Getzenberg - GTx, Inc., Memphis, TNChristopher Coss - GTx, Inc., Memphis, TNMichael L. Hancock - GTx, Inc., Memphis, TNJames T. Dalton - GTx, Inc., Memphis, TNMitchell S. Steiner - GTx, Inc., Memphis, TN
- Publication Details
- Journal of clinical oncology, v 31(6_suppl)
- Publisher
- AMER SOC CLINICAL ONCOLOGY
- Number of pages
- 1
- Resource Type
- Abstract
- Language
- English
- Academic Unit
- Surgery
- Web of Science ID
- WOS:000333679600172
- Other Identifier
- 991021916913004721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- Web of Science research areas
- Oncology