Neoplasms, ProstatePhase 4NCT00470834
Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy
A Phase 4 study testing dutasteride and bicalutamide in people with Neoplasms, Prostate, run by GlaxoSmithKline at 62 sites in 2 countries.
Trial summary
Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT) the male hormone that leads to benign prostate growth. By blocking the conversion of testosterone to DHT, dutasteride could allow bicalutamide to be a more effective anti-androgen thus prolonging bicalutamide's efficacy. Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- Neoplasms, Prostate
- What is being tested?
- dutasteride and bicalutamide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 62 sitesin 2 countries
- Study dates
- May 2007to Feb 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men ≥40 and ≤90 years of age
- Must have asymptomatic prostate cancer that has progressed during androgen deprivation therapy (rising PSA). PSA progression must have occurred after first-line treatment with GnRH analogues ( e.g. leuprolide, goserelin) or orchiectomy. PSA progression is defined by three rises in PSA each measured at least 4 weeks apart within the previous year.
- Serum PSA ≥2 and ≤20ng/ml from central laboratory. One PSA retest from central laboratory is allowed if the value is <2 or >20ng/ml; or if the PSA value is not consistent with the previous rising PSA values that determined progression while on a GnRH analogue.
- Serum Testosterone <50ng/ml from central laboratory.
- Non-metastatic prostate cancer as confirmed on prior bone scan performed within 8 weeks of screening.
- Expected survival ≥ 2 years
- ECOG Performance status 0, 1, or 2
Who cannot join
- Additional hormonal therapy (excluding the current use of a GnRH analogue) within the past 6 months of:
- Estrogens (e.g. megestrol, medroxyprogesterone, cyproterone, DES)
- Drugs with antiandrogenic properties (e.g., spironolactone if >50mg/day, flutamide, bicalutamide*, ketoconazole**, progestational agents)
- The use of an antiandrogen during GnRH analogue induction for <6 weeks is acceptable, but none within the 3 months prior to study entry.
- The use of topical ketoconazole is permitted prior to and during the study. NOTE: Use of dietary and herbal supplements (e.g., selenium, Vitamin E, saw palmetto), excluding daily vitamins, during the study is discouraged, but not prohibited. All dietary and herbal supplement usage will be recorded in the eCRF.
- Treatment with oral glucocorticoids during the 3 months prior to randomization or expectation of their use during the study.
Show all 19Show fewer
- Prior chemotherapy for prostate cancer. (prior prostatectomy or radiotherapy to the prostate are allowed)
- Prostate surgery including TUNA, TURP, TUIP, laser treatment, thermotherapy, balloon dilatation, prosthesis, and cryosurgical ablation within 2 months prior to enrollment.
- Current and/or previous use of the following medications:
- Finasteride (Proscar, Propecia), or Dutasteride (GI198745, AVODART) exposure within 6 months prior to study entry
- Anabolic steroids (within 6 months prior to study entry)
- Participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or anytime during the study period.
- Any unstable serious co-existing medical condition(s) including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes; or peptic ulcer disease which is uncontrolled by medical management.
- Abnormal liver function test greater than 1.5 times the upper limit of normal for alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP] or bilirubin.
- Serum creatinine >2.0 times the upper limit of normal.
- History of another malignancy within five years that could affect the treatment of prostate cancer or survival of the subject.
- History or current evidence of drug or alcohol abuse within the last 12 months.
- History of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject.
- Known hypersensitivity to any 5 alpha-reductase inhibitor or to any drug chemically related to dutasteride.
Trial locations and contacts
62 sites in 2 countries.
62 sites in 2 countries
United States47 sites
GSK Investigational Site
Albany, New York, 12208
GSK Investigational Site
Anaheim, California, 92801
GSK Investigational Site
Annapolis, Maryland, 21401
GSK Investigational Site
Aventura, Florida, 33180
GSK Investigational Site
Bala-Cynwyd, Pennsylvania, 19004
GSK Investigational Site
Chaska, Minnesota, 55318
GSK Investigational Site
Columbus, Ohio, 43214
GSK Investigational Site
Concord, North Carolina, 28025
GSK Investigational Site
Daytona Beach, Florida, 32114
GSK Investigational Site
Denver, Colorado, 80211
GSK Investigational Site
Evansville, Indiana, 47713
GSK Investigational Site
Fort Wayne, Indiana, 46825
GSK Investigational Site
Fresno, California, 93720
GSK Investigational Site
Galesburg, Illinois, 61401
GSK Investigational Site
Garden City, New York, 11530
GSK Investigational Site
Homewood, Alabama, 35209
GSK Investigational Site
Houston, Texas, 77074
GSK Investigational Site
Huntsville, Alabama, 35801
GSK Investigational Site
Jeffersonville, Indiana, 47130
GSK Investigational Site
Lancaster, Pennsylvania, 17604
GSK Investigational Site
Las Vegas, Nevada, 89148
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Manhasset, New York, 11030
GSK Investigational Site
Memphis, Tennessee, 38119
GSK Investigational Site
Milwaukee, Wisconsin, 53226
GSK Investigational Site
Minneapolis, Minnesota, 55455
GSK Investigational Site
Myrtle Beach, South Carolina, 29572
GSK Investigational Site
New Orleans, Louisiana, 70112
GSK Investigational Site
New York, New York, 10016
GSK Investigational Site
Norfork, Virginia, 23502
GSK Investigational Site
Omaha, Nebraska, 68114
GSK Investigational Site
Orlando, Florida, 32803
GSK Investigational Site
Overland Park, Kansas, 66211
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Richmond, Virginia, 23235
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Bernardino, California, 92404
GSK Investigational Site
San Diego, California, 92101
GSK Investigational Site
Seattle, Washington, 98166
GSK Investigational Site
Seattle, Washington, 98195-6015
GSK Investigational Site
Shreveport, Louisiana, 71106
GSK Investigational Site
St Louis, Missouri, 63136
GSK Investigational Site
Syracuse, New York, 13210
GSK Investigational Site
Virginia Beach, Virginia, 23454
GSK Investigational Site
Washington D.C., District of Columbia, 20307
GSK Investigational Site
Watertown, Massachusetts, 02472
GSK Investigational Site
Williamsburg, Virginia, 23185
Canada15 sites
GSK Investigational Site
Barrie, Ontario, L4M 7G1
GSK Investigational Site
Burlington, Ontario, L7S 1V2
GSK Investigational Site
Calgary, Alberta, T2V 1P9
GSK Investigational Site
Greater Sudbury, Ontario, P3E 4T3
GSK Investigational Site
Greenfield Park, Quebec, J4V 2H3
GSK Investigational Site
Laval, Quebec, H7G 2E6
GSK Investigational Site
North Bay, Ontario, P1B 7K8
GSK Investigational Site
Oakville, Ontario, L6H 3P1
GSK Investigational Site
Pointe-Claire, Quebec, H9R 4S3
GSK Investigational Site
Québec, Quebec, G1R 2J6
GSK Investigational Site
Scarborough Village, Ontario, M1S 4V5
GSK Investigational Site
Surrey, British Columbia, V3V 1N1
GSK Investigational Site
Toronto, Ontario, M2K 2W1
GSK Investigational Site
Toronto, Ontario, M4C 5T2
GSK Investigational Site
Victoria, British Columbia, V8T 5G1
About this study
Official title: A Randomized Double-Blind Parallel Group Study Comparing Casodex (or Generic Equivalent) 50mg Plus Placebo to Casodex (or Generic Equivalent) 50mg Plus Dutasteride 3.5mg Administered for 18 Months to Men With Prostate Cancer Who Have Failed First-Line Androgen Deprivation Therapy (Assessed by Rising PSA) Followed by a Two-Year Extension Phase
Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT) the male hormone that leads to benign prostate growth. By blocking the conversion of testosterone to DHT, dutasteride could allow bicalutamide to be a more effective anti-androgen thus prolonging bicalutamide's efficacy.
- Conditions
- Neoplasms, Prostate
- Being tested
- dutasteride, placebo, bicalutamide
- Keywords
- prostate cancer, androgen deprivation therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dutasterideDrug
0.5mg dutasteride (Investigation Product)
placeboDrug
making placebo
bicalutamideDrug
50 mg Casodex or generic equivalent
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 50 mg bicalutamide and 3.5 mg Dutasteride (IP) Receives: Drug: dutasteride; Drug: bicalutamide |
| Arm 2 | Placebo comparator | 50 mg bicalutamide and placebo Receives: Drug: placebo; Drug: bicalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Disease Progression
Time to disease progression (PD) is defined as the interval of time between the date of the start of treatment and the date of PD. PD is defined as prostate specific antigen (PSA) progression from Baseline (PSA value is 25% and at least 2 nanograms per milliliter [ng/mL] above Baseline, confirmed by a second PSA value); PSA progression from nadir, without a 50% decrease from Baseline (PSA value is 25% and at least 2 ng/mL above nadir, confirmed by a second PSA value); PSA progression from nadir, with a 50% or more decrease from Baseline (PSA value is 50% and at least 2 ng/mL above nadir, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or the receipt of post-Baseline rescue medication. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.
Measured: Interval of time between the date of the start of treatment and the date of disease progression (up to Study Month 42)
Secondary outcomes (4)
Time to Treatment Failure
Time to treatment failure is defined as the interval of time between the date of the start of treatment and the date of treatment failure. Treatment failure is defined as PSA progression from Baseline (PSA value is 25% and at least 2 ng/mL above Baseline, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or receipt of post-baseline rescue medications. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.
Measured: Interval of time between the date of the start of treatment and the date of treatment failure (up to Study Month 42)
Number of Participants With PSA Response
PSA response is defined as a 50% or greater decrease in PSA from Baseline, confirmed by a second PSA measurement. The time of this response was the date of the first PSA measurement that showed a 50% or greater decrease from the Baseline PSA measurement. PSA confirmation was not required if no subsequent PSA values were available.
Measured: Time from Baseline PSA measurement until the first PSA measurement with a 50% or greater reduction in PSA values (up to Study Month 42)
Change From Baseline in Total PSA at Months 6, 12, 18, 21, and 42
Change from Baseline in total PSA was measured at each scheduled post-baseline visit using a general linear model with effects for treatment and Baseline total PSA. Analysis was done using the last observation carried forward (LOCF) approach, in which missing post-Baseline values were imputed with earlier non-missing values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline and Months 6, 12, 18, 21, and 42
Number of Participants With Metastatic Disease
Metastatic disease is that evidenced by a radiographic assessment. The time of metastatic disease was the date of radiographic evidence.
Measured: Interval of time between the date of the start of treatment and the date of radiographic evidence of metastatic disease (up to Study Month 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2007 (estimated)
- Study startMay 2007
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neoplasms, ProstateStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470834
- Sponsor's protocol ID
- AVO108943
- Status last verified
- Nov 2016
- First submitted
- 7 May 2007
- Last updated
- 27 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Parallel Group Study Comparing Casodex (or Generic Equivalent) 50mg Plus Placebo to Casodex (or Generic Equivalent) 50mg Plus Dutasteride 3.5mg Administered for 18 Months to Men With Prostate Cancer Who Have Failed First-Line Androgen Deprivation Therapy (Assessed by Rising PSA) Followed by a Two-Year Extension Phase
- ClinicalTrials.gov ID
- NCT00470834
- Acronym / sponsor ID
- AVO108943
- Conditions
- Neoplasms, Prostate
- Keywords
- prostate cancer, androgen deprivation therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 8 May 2007 (estimated)
- Results
- Posted 1 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT) the male hormone that leads to benign prostate growth. By blocking the conversion of testosterone to DHT, dutasteride could allow bicalutamide to be a more effective anti-androgen thus prolonging bicalutamide's efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: dutasteride, Drug: bicalutamide50 mg bicalutamide and 3.5 mg Dutasteride (IP) |
| Arm 2 | Placebo comparator | Drug: placebo, Drug: bicalutamide50 mg bicalutamide and placebo |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men ≥40 and ≤90 years of age
- Must have asymptomatic prostate cancer that has progressed during androgen deprivation therapy (rising PSA). PSA progression must have occurred after first-line treatment with GnRH analogues ( e.g. leuprolide, goserelin) or orchiectomy. PSA progression is defined by three rises in PSA each measured at least 4 weeks apart within the previous year.
- Serum PSA ≥2 and ≤20ng/ml from central laboratory. One PSA retest from central laboratory is allowed if the value is <2 or >20ng/ml; or if the PSA value is not consistent with the previous rising PSA values that determined progression while on a GnRH analogue.
- Serum Testosterone <50ng/ml from central laboratory.
- Non-metastatic prostate cancer as confirmed on prior bone scan performed within 8 weeks of screening.
Key exclusion criteria (19 listed)
- Additional hormonal therapy (excluding the current use of a GnRH analogue) within the past 6 months of:
- Estrogens (e.g. megestrol, medroxyprogesterone, cyproterone, DES)
- Drugs with antiandrogenic properties (e.g., spironolactone if >50mg/day, flutamide, bicalutamide*, ketoconazole**, progestational agents)
- The use of an antiandrogen during GnRH analogue induction for <6 weeks is acceptable, but none within the 3 months prior to study entry.
- The use of topical ketoconazole is permitted prior to and during the study. NOTE: Use of dietary and herbal supplements (e.g., selenium, Vitamin E, saw palmetto), excluding daily vitamins, during the study is discouraged, but not prohibited. All dietary and herbal supplement usage will be recorded in the eCRF.
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 |
|---|---|---|
| dutasteride0.5mg dutasteride (Investigation Product) | Drug | Arm 1 |
| placebomaking placebo | Drug | Arm 2 |
| bicalutamide50 mg Casodex or generic equivalent | Drug | Arm 1, Arm 2 |
Primary outcome
Time to Disease Progression
Time frame: Interval of time between the date of the start of treatment and the date of disease progression (up to Study Month 42)
Time to disease progression (PD) is defined as the interval of time between the date of the start of treatment and the date of PD. PD is defined as prostate specific antigen (PSA) progression from Baseline (PSA value is 25% and at least 2 nanograms per milliliter [ng/mL] above Baseline, confirmed by a second PSA value); PSA progression from nadir, without a 50% decrease from Baseline (PSA value is 25% and at least 2 ng/mL above nadir, confirmed by a second PSA value); PSA progression from nadir, with a 50% or more decrease from Baseline (PSA value is 50% and at least 2 ng/mL above nadir, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or the receipt of post-Baseline rescue medication. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.
4 secondary outcomes
Time to Treatment Failure
Time frame: Interval of time between the date of the start of treatment and the date of treatment failure (up to Study Month 42)
Number of Participants With PSA Response
Time frame: Time from Baseline PSA measurement until the first PSA measurement with a 50% or greater reduction in PSA values (up to Study Month 42)
Change From Baseline in Total PSA at Months 6, 12, 18, 21, and 42
Time frame: Baseline and Months 6, 12, 18, 21, and 42
Number of Participants With Metastatic Disease
Time frame: Interval of time between the date of the start of treatment and the date of radiographic evidence of metastatic disease (up to Study Month 42)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
62 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dutasteride and bicalutamide in people with Neoplasms, Prostate, run by GlaxoSmithKline at 62 sites in 2 countries.
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 19 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 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Disease Progression (time frame: Interval of time between the date of the start of treatment and the date of disease progression (up to Study Month 42)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2017.