Prostate CancerPhase 2/3AVIASNCT00553878
Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Androgen Ablation Therapy for Prostate Cancer
A Phase 2/3 study testing Dutasteride in people with Prostate Cancer, run by Canadian Urology Research Consortium at 1 site in Canada.
Trial summary
Patient on an intermittent androgen deprivation protocol for biochemical recurrence after radical local therapy for prostate cancer,the addition of continuous dutasteride treatment, significantly prolongs the duration of the off treatment interval and time to androgen independence. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Dutasteride
- 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
- 1 siteCanada
- Study dates
- Mar 2007to Dec 2012
- Phase
- Phase 2/3
- 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 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give informed consent
- Age_>45and<_80
- Histological confirmed adenocarcinoma of prostate
- Has received external beam radiation,brachytherapy or radical prostatectomy for the treatment of prostate ca
- Candidate for intermittent androgen ablation
- Minimum of 3 PSA values above nadir taken at least 1 month apart
Show all 9Show fewer
- Serum testosterone >_250ng/dl,ECOG 0 or 1
- Negative bone scan within 12 months of visit 1
- Able to swallow and retain oral medication
Who cannot join
- Previous treatment with chemotherapy
- Hormonal therapy with in last year
- Glucocorticoid with in last 3 months
- LHRH analogues with in previous year
- Ketoconazole
- Non Steroidal anti-androgens with in previous year
Show all 16Show fewer
- Concurrent or previous use of Finasteride Dutasteride 5a reductase inhibitor anabolic steroids
- Over the counter or herbal prep such as saw palmetto selenium or vitamin E within last year
- May not be receiving any other investigational drug with in last 30 days
- Evidence of distant metastases
- Has received adjuvant or neoadjuvant ablation in past 12 months
- Unstable serious co-existing medical condition
- Abnormal liver and kidney functions
- Previous malignancy not including curative treated basal cell carcinoma of skin with in 5 years and bladder cancer with in past 2 years
- Known hypersensitivity to any 5a-reductase inhibitor or to any drug chemically related to dutasteride
- Known hypersensitivity to bicalutamide.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi Center Double Blind Study Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Intermittent Androgen Ablation Therapy for Prostate Cancer
Patient on an intermittent androgen deprivation protocol for biochemical recurrence after radical local therapy for prostate cancer,the addition of continuous dutasteride treatment, significantly prolongs the duration of the off treatment interval and time to androgen independence.
Read the detailed description
The study is to assess the effect of therapy with repeat oral daily dosing of dutasteride 05 mg on the length of the off treatment interval in men receiving intermittent androgen therapy for localized prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Dutasteride
- 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
Also called placebo
dutasteride 0.5mg capsule daily until serum PSA rises to 5ng/ml in the off treatment interval
| Study group | Role | What they receive |
|---|---|---|
| dutasteride | Placebo comparator | Not described Receives: Drug: Dutasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether repeat oral once daily dosing of dutasteride 0.5mg increases the length of the off treatment interval in men receiving intermittent androgen ablation therapy for localized prostate cancer
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startMar 2007
- Primary completionSep 2009
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Urology Research Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Laurence Klotz, MD, Principal investigator, CURCLarry S Goldeng, Principal investigator, CUOG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553878
- Sponsor's protocol ID
- CURC/CUOG-AVIAS-0601
- Acronym
- AVIAS
- Status last verified
- Dec 2012
- First submitted
- 5 Nov 2007
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: plan to share in publication
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Center Double Blind Study Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Intermittent Androgen Ablation Therapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT00553878
- Acronym / sponsor ID
- AVIAS / CURC/CUOG-AVIAS-0601
- Conditions
- Prostate Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Canadian Urology Research ConsortiumUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 6 Nov 2007 (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.
Patient on an intermittent androgen deprivation protocol for biochemical recurrence after radical local therapy for prostate cancer,the addition of continuous dutasteride treatment, significantly prolongs the duration of the off treatment interval and time to androgen independence.
Detailed description
The study is to assess the effect of therapy with repeat oral daily dosing of dutasteride 05 mg on the length of the off treatment interval in men receiving intermittent androgen therapy for localized prostate cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dutasteride | Placebo comparator | Drug: Dutasteride |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able to give informed consent
- Age_>45and<_80
- Histological confirmed adenocarcinoma of prostate
- Has received external beam radiation,brachytherapy or radical prostatectomy for the treatment of prostate ca
- Candidate for intermittent androgen ablation
Key exclusion criteria (16 listed)
- Previous treatment with chemotherapy
- Hormonal therapy with in last year
- Glucocorticoid with in last 3 months
- LHRH analogues with in previous year
- Ketoconazole
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 |
|---|---|---|
| DutasterideAlso: placebodutasteride 0.5mg capsule daily until serum PSA rises to 5ng/ml in the off treatment interval | Drug | dutasteride |
Primary outcome
To assess whether repeat oral once daily dosing of dutasteride 0.5mg increases the length of the off treatment interval in men receiving intermittent androgen ablation therapy for localized prostate cancer
Time frame: 2 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 14 Oct 2016.
- Individual participant dataSharing planned: Yes. plan to share in publication
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Laurence Klotz, MD principal investigator
CURC
Larry S Goldeng principal investigator
CUOG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dutasteride in people with Prostate Cancer, run by Canadian Urology Research Consortium at 1 site in Canada.
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 9 inclusion and 16 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 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 assess whether repeat oral once daily dosing of dutasteride 0.5mg increases the length of the off treatment interval in men receiving intermittent androgen ablation therapy for localized prostate cancer (time frame: 2 Years). 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 14 Oct 2016.