NCT00182052

Brief Summary

The purpose of this study it to learn the effects (good or bad) that rosiglitazone has on patients and their prostate cancer. This study is going to look at what effects rosiglitazone has on prostate specific antigen (PSA) levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2000

Typical duration for phase_3

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

September 1, 2000

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

May 23, 2013

Status Verified

May 1, 2013

Enrollment Period

2.9 years

First QC Date

September 14, 2005

Last Update Submit

May 22, 2013

Conditions

Adenocarcinoma of the ProstateProstate Cancer

Keywords

rosiglitazoneAvandiaandrogen dependant prostate cancer

Outcome Measures

Primary Outcomes (1)

  • To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men.

    3 years

Secondary Outcomes (1)

  • Evaluate time to PSA progression as a measure of the activity of rosiglitazone.

    3 years

Study Arms (2)

Group 1

ACTIVE COMPARATOR
Drug: Rosiglitazone

Group 2

PLACEBO COMPARATOR
Other: Placebo

Interventions

RosiglitazoneDRUG

Given orally twice daily. Participants may continue study treatment as long as their disease does not progress and they don't experience any serious side effects.

Also known as: Avandia
Group 1
PlaceboOTHER

Given orally twice daily.

Group 2

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed adenocarcinoma of the prostate
  • Biochemical disease progression following local therapy defined as three rises in PSA with each PSA determination at least 4 weeks apart and each PSA value \> or = 0.2ng/ml
  • For men treated with radical prostatectomy, PSA \> or = 2 ng/ml
  • For men treated with primary radiation therapy or post-prostatectomy radiation therapy, PSA \> or = 2 ng/ml and \> 150% post-radiation nadir
  • Not an appropriate candidate for salvage radiation therapy or salvage prostatectomy
  • Baseline PSADT \< 24 months
  • CALGB performance status of 0,1 or 2

You may not qualify if:

  • Metastatic disease
  • Prior hormonal therapy for recurrent prostate cancer
  • Prior chemotherapy for prostate cancer
  • Current treatment with insulin or an oral hypoglycemic
  • History of treatment with thiazolidinediones
  • Radiation therapy within 6 months
  • SGOT \> 1.5 x ULN
  • Fasting blood glucose \< 60 mg/dl
  • NYHA Class 3 or 4 cardiac status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Smith MR, Manola J, Kaufman DS, George D, Oh WK, Mueller E, Slovin S, Spiegelman B, Small E, Kantoff PW. Rosiglitazone versus placebo for men with prostate carcinoma and a rising serum prostate-specific antigen level after radical prostatectomy and/or radiation therapy. Cancer. 2004 Oct 1;101(7):1569-74. doi: 10.1002/cncr.20493.

    PMID: 15468186BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Matthew Smith, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

September 1, 2000

Primary Completion

August 1, 2003

Study Completion

August 1, 2003

Last Updated

May 23, 2013

Record last verified: 2013-05

Locations

US(2)