Adenocarcinoma of the ProstatePhase 3NCT00182052
Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer
A Phase 3 study testing Rosiglitazone in people with Adenocarcinoma of the Prostate and Prostate Cancer, run by Massachusetts General Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate, Prostate Cancer
- What is being tested?
- Rosiglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2000to Aug 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- SGOT > 1.5 x ULN
- Fasting blood glucose < 60 mg/dl
- NYHA Class 3 or 4 cardiac status
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer: A Randomized Double-Blind, Placebo Controlled Phase III Study
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.
Read the 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.
- Conditions
- Adenocarcinoma of the Prostate, Prostate Cancer
- Being tested
- Rosiglitazone, Placebo
- Keywords
- rosiglitazone, Avandia, androgen dependant prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosiglitazoneDrug
Also called Avandia
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.
PlaceboOther
Given orally twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Not described Receives: Drug: Rosiglitazone |
| Group 2 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men.
Measured: 3 years
Secondary outcomes (1)
Evaluate time to PSA progression as a measure of the activity of rosiglitazone.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2000
- Primary completionAug 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Matthew R. Smith, MD, PhD, Massachusetts General Hospital
- Investigators
- Matthew Smith, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182052
- Sponsor's protocol ID
- 00-100
- Status last verified
- May 2013
- First submitted
- 14 Sep 2005
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15468186
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer: A Randomized Double-Blind, Placebo Controlled Phase III Study
- ClinicalTrials.gov ID
- NCT00182052
- Acronym / sponsor ID
- 00-100
- Conditions
- Adenocarcinoma of the Prostate, Prostate Cancer
- Keywords
- rosiglitazone, Avandia, androgen dependant prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Study start
- Sep 2000
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Rosiglitazone |
| Group 2 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosiglitazoneAlso: AvandiaGiven 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. | Drug | Group 1 |
| PlaceboGiven orally twice daily. | Other | Group 2 |
Primary outcome
To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men.
Time frame: 3 years
1 secondary outcome
Evaluate time to PSA progression as a measure of the activity of rosiglitazone.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2013.
- Background: PubMed 15468186Smith 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Smith, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosiglitazone in people with Adenocarcinoma of the Prostate and Prostate Cancer, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00182052, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2013.