NCT00455624

Brief Summary

The purpose of this study is to find out if androgen deprivation therapy affects insulin, cardiac risk factors such as cholesterol level, and body fat and muscle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2002

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2007

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

3.5 years

First QC Date

April 2, 2007

Last Update Submit

July 9, 2013

Conditions

Prostate Cancer

Keywords

androgen deprivation therapyinsulin resistance

Outcome Measures

Primary Outcomes (1)

  • insulin sensitity

    12 weeks

Interventions

Androgen deprivation therapyDRUG

According to standard medical care

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men identified with prostate cancer.

You may qualify if:

  • Adenocarcinoma of the prostate, clinical stage M0
  • About to initiate GnRH agonist therapy
  • Karnofsky Performance Status 90 or 100
  • Serum creatinine \< 2.0mg/dl

You may not qualify if:

  • Hormone therapy within 12 months
  • History of diabetes mellitus or glucose intolerance
  • Anabolic agents or metabolic agents known to affect insulin or glucose levels
  • Prior hormone therapy within the past 12 months and planned hormone therapy during the 12 week study (Group 2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Smith 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: 16434464BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Prostatic NeoplasmsInsulin Resistance

Interventions

Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hormone AntagonistsHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Matthew Smith, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

April 2, 2007

First Posted

April 4, 2007

Study Start

November 1, 2002

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

US(2)