Clinical trial · Observational
Androgen Deprivation Therapy Study
Metabolic and Cardiovascular Complications in Men With Prostate Cancer Undergoing Long-term Androgen Deprivation Therapy
NCT00743327CI-TRIAL-00007736ADTterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No Participants completed study
Summary
Brief summary (as posted)
The purpose of this study is to examine the link between low testosterone and insulin resistance/diabetes in men undergoing androgen deprivation therapy for prostate cancer. The study will also evaluate other cardiovascular risk factors in these men.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diabetes | — | UNRESOLVED | — |
| Hypogonadism | — | UNRESOLVED | — |
| Inflammation | — | UNRESOLVED | — |
| Metabolic Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pioglitazone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- 1
- description
- Participants receiving ADT and pioglitazone
- interventionNames
- Drug: Pioglitazone
- label
- 2
- description
- Participants receiving ADT only
- label
- 3
- description
- Participants not receiving ADT and in remission from prostate cancer
Primary outcomes (1)
- measure
- Evaluation for the development of incident diabetes
- timeFrame
- every 3 months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men 18 years of age or older with prostate cancer * Planning to undergo long-term (at least 12 months) ADT * No known history of diabetes * No history of ADT Exclusion Criteria: * History of ADT or any prior diagnosis of hypogonadism * Fasting glucose or oral glucose tolerance test results in the diabetic range * Heart failure (NY classification III or IV) * Testosterone level less than 250 ng/dl on screening * History of heart attack or open-heart surgery within the past 6 months * Use of steroids within the past 3 months, including prednisone, cortisone injections, inhaled steroids (topical steroids are acceptable) * Use of anabolic steroids (testosterone, DHEA, DHEAS) or any growth promoters (growth hormone itself or analogs of growth hormone) in the past 12 months * Liver function tests more than 3 times upper normal limits * Undergoing intermittent ADT * Uncontrolled thyroid disease (hyper- or hypo-thyroidism) * Anemia, defined as hematocrit less than 38% * Not physically capable of completing the tests
References
Publications (5)
- BACKGROUNDDockery F, Bulpitt CJ, Agarwal S, Donaldson M, Rajkumar C. Testosterone suppression in men with prostate cancer leads to an increase in arterial stiffness and hyperinsulinaemia. Clin Sci (Lond). 2003 Feb;104(2):195-201. doi: 10.1042/CS20020209. PMID 12546642
- BACKGROUNDSmith MR, Lee H, Nathan DM. Insulin sensitivity during combined androgen blockade for prostate cancer. J Clin Endocrinol Metab. 2006 Apr;91(4):1305-8. doi: 10.1210/jc.2005-2507. Epub 2006 Jan 24. PMID 16434464
- BACKGROUNDBasaria S, Muller DC, Carducci MA, Egan J, Dobs AS. Hyperglycemia and insulin resistance in men with prostate carcinoma who receive androgen-deprivation therapy. Cancer. 2006 Feb 1;106(3):581-8. doi: 10.1002/cncr.21642. PMID 16388523
- BACKGROUNDKeating NL, O'Malley AJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J Clin Oncol. 2006 Sep 20;24(27):4448-56. doi: 10.1200/JCO.2006.06.2497. PMID 16983113
- BACKGROUNDBraga-Basaria M, Dobs AS, Muller DC, Carducci MA, John M, Egan J, Basaria S. Metabolic syndrome in men with prostate cancer undergoing long-term androgen-deprivation therapy. J Clin Oncol. 2006 Aug 20;24(24):3979-83. doi: 10.1200/JCO.2006.05.9741. PMID 16921050