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

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

This study is ongoing, but not recruiting participants.

First Received on November 5, 2007. Last Updated on December 20, 2011 History of Changes

Sponsor:	Canadian Urology Research Consortium
Collaborator:	GlaxoSmithKline
Information provided by (Responsible Party):	Canadian Urology Research Consortium
ClinicalTrials.gov Identifier:	NCT00553878

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: Dutasteride	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Dutasteride

U.S. FDA Resources

Further study details as provided by Canadian Urology Research Consortium:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2007
Estimated Study Completion Date:	March 2012
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: dutasteride	Drug: Dutasteride dutasteride 0.5mg capsule daily until serum PSA rises to 5ng/ml in the off treatment interval Other Name: placebo

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.

Eligibility

Ages Eligible for Study:	45 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553878

Locations

Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5

Sponsors and Collaborators

Canadian Urology Research Consortium

GlaxoSmithKline

Investigators

Principal Investigator:	Laurence Klotz, MD	CURC
Principal Investigator:	Larry S Goldeng	CUOG

More Information

No publications provided

Responsible Party:	Canadian Urology Research Consortium
ClinicalTrials.gov Identifier:	NCT00553878 History of Changes
Obsolete Identifiers:	NCT00516815
Other Study ID Numbers:	CURC/CUOG-AVIAS-0601
Study First Received:	November 5, 2007
Last Updated:	December 20, 2011
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens

Dutasteride
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012