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Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer

Primary Purpose

Adenocarcinoma of the Prostate, Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rosiglitazone
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Prostate focused on measuring rosiglitazone, Avandia, androgen dependant prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 14, 2005
Last Updated
May 22, 2013
Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00182052
Brief Title
Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer
Official Title
Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer: A Randomized Double-Blind, Placebo Controlled Phase III Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Patients will be randomly assigned to initial treatment with either rosiglitazone or placebo orally twice daily, every day as long as there is no disease progression or serious side effects. Patients will be asked to complete a drug log to keep track of the medication. Before treatment begins the following tests will be performed: physical exam; bone scan; blood work (including PSA level test) and a urine sample. While on this study the following tests and procedures will be done once a month: review of side effects and routine blood tests (including PSA levels). While on this study the following tests and procedures will be done on months 2 and 4: review of side effects; routine blood tests (including PSA levels) and urine tests. If the patient's disease progressed the treatment code will be broken and if the patient was on placebo, they will have the option to begin taking rosiglitazone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate, Prostate Cancer
Keywords
rosiglitazone, Avandia, androgen dependant prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Title
Group 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rosiglitazone
Other Intervention Name(s)
Avandia
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Given orally twice daily.
Primary Outcome Measure Information:
Title
To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Evaluate time to PSA progression as a measure of the activity of rosiglitazone.
Time Frame
3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Smith, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15468186
Citation
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.
Results Reference
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Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer

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