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CompletedNCT00553878AVIASUpdated Oct 14, 2016

Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Androgen Ablation Therapy for Prostate Cancer

A Phase 2/3 interventional study of Dutasteride in Prostate Cancer, sponsored by Canadian Urology Research Consortium. Completed at 1 site in Canada. Open to male participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-10-14.

Sponsored by Canadian Urology Research Consortium · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's planned enrollment of 100 is above the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Canadian Urology Research Consortium is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • Serum testosterone >_250ng/dl,ECOG 0 or 1
  • Negative bone scan within 12 months of visit 1
  • Able to swallow and retain oral medication

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Care provider)
Enrollment
100 participants (estimated)

Study arms

  • Placebo comparator
    dutasteride

    Drug: Dutasteride

Interventions

  • DrugDutasteride

    dutasteride 0.5mg capsule daily until serum PSA rises to 5ng/ml in the off treatment interval

    Also known as: placebo

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario M4N 3M5, Canada
08

References and documents

Individual participant data

Plan to share: Yes — plan to share in publication

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2007, a primary completion of Sep 2009 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2007
First posted
Nov 6, 2007
Start
Mar 2007
Primary completionActual
Sep 2009
CompletionActual
Dec 2012
Last update
Oct 14, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00553878
Lead sponsor
Canadian Urology Research Consortium
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
Nov 6, 2007
Start date
Mar 2007
Primary completion
Sep 2009
Completion
Dec 2012
Last update
Oct 14, 2016

Study contacts

Laurence Klotz, MD
principal investigator · CURC
Larry S Goldeng
principal investigator · CUOG

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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