Document Detail


Kinetics of serum androgen normalization and factors associated with testosterone reserve after limited androgen deprivation therapy for nonmetastatic prostate cancer.
MedLine Citation:
PMID:  18710748     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: Groups have investigated time to testosterone recovery in patients who have undergone androgen deprivation therapy, usually by measuring androgen every 3 months, with varying results. To our knowledge this represents the largest study using monthly testosterone and dihydroxytestosterone measurement to evaluate the kinetics of androgen recovery following limited androgen deprivation therapy.
MATERIALS AND METHODS: Monthly serum androgen levels were analyzed following 2, 6-month cycles of gonadotropin-releasing hormone agonist therapy as part of a randomized, placebo controlled study of the role of thalidomide in delaying time to prostate specific androgen progression.
RESULTS: By the Kaplan-Meier method the median time to testosterone normalization in cycles 1 vs 2 was 15.4 vs 18.3 weeks with similar dihydroxytestosterone recovery times. Neither on-study prostate specific antigen, Gleason score nor thalidomide treatment had a significant impact on time to testosterone normalization. However, in cycle 1 men with low baseline dihydroxytestosterone and those who were more than 67 years old had significantly longer time to T normalization on Cox model analysis. Additionally, in cycle 2 patients with prior local radiation therapy had longer time to testosterone normalization, although this was no longer significant on Cox model analysis. Cox model analysis in cycle 2 showed that low baseline dihydroxytestosterone and testosterone, low testosterone nadir and white race were associated with longer time to testosterone normalization.
CONCLUSIONS: Findings of delayed testosterone recovery may be useful for designing and analyzing clinical trials of limited androgen deprivation therapy and for estimating the duration of treatment associated side effects in patients undergoing limited androgen deprivation therapy.
Authors:
James L Gulley; Jeanny B Aragon-Ching; Seth M Steinberg; Maha H Hussain; Oliver Sartor; Celestia S Higano; Daniel P Petrylak; Gurkamal S Chatta; Philip M Arlen; William D Figg; William L Dahut
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, N.I.H., Intramural     Date:  2008-08-16
Journal Detail:
Title:  The Journal of urology     Volume:  180     ISSN:  1527-3792     ISO Abbreviation:  J. Urol.     Publication Date:  2008 Oct 
Date Detail:
Created Date:  2008-09-12     Completed Date:  2008-09-30     Revised Date:  2012-03-07    
Medline Journal Info:
Nlm Unique ID:  0376374     Medline TA:  J Urol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1432-7; discussion 1437     Citation Subset:  AIM; IM    
Affiliation:
Center for Cancer Research, Laboratory of Tumor Immunology and Biology, National Cancer Institute, Bethesda, Maryland 20892, USA. gulleyj@mail.nih.gov
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Androgen Antagonists / therapeutic use*
Androgens / blood*,  metabolism
Antineoplastic Agents, Hormonal / therapeutic use*
Biopsy, Needle
Dose-Response Relationship, Drug
Drug Administration Schedule
Follow-Up Studies
Goserelin / therapeutic use
Humans
Immunohistochemistry
Leuprolide / therapeutic use
Male
Middle Aged
Neoplasm Staging
Probability
Prospective Studies
Prostate-Specific Antigen / blood
Prostatic Neoplasms / drug therapy*,  pathology*
Recovery of Function
Reference Values
Risk Assessment
Testosterone / blood*,  metabolism
Thalidomide / therapeutic use
Treatment Outcome
Grant Support
ID/Acronym/Agency:
NIH0011802535//PHS HHS; Z99 CA999999/CA/NCI NIH HHS
Chemical
Reg. No./Substance:
0/Androgen Antagonists; 0/Androgens; 0/Antineoplastic Agents, Hormonal; 50-35-1/Thalidomide; 53714-56-0/Leuprolide; 58-22-0/Testosterone; 65807-02-5/Goserelin; EC 3.4.21.77/Prostate-Specific Antigen
Comments/Corrections

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