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 currently recruiting participants.

Verified by Canadian Urology Research Consortium, August 2009

First Received: November 5, 2007 Last Updated: August 11, 2009 History of Changes

Sponsor:	Canadian Urology Research Consortium
Collaborator:	GlaxoSmithKline
Information provided by:	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:	Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Single Group Assignment, Safety/Efficacy 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

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
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

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

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

Contacts

Contact: Laurence Klotz, MD	416 480 4673	laurence.klotz@sunnybrook.ca
Contact: Larry S Goldenberg, MD

Locations

Canada, Ontario
Sunnybrook Health Sciences Centre	Recruiting
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 ( Dr. Laurence Klotz )
Study ID Numbers:	CURC/CUOG-AVIAS-0601
Study First Received:	November 5, 2007
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00553878 History of Changes
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Genital Neoplasms, Male
Prostatic Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Urogenital Neoplasms
Genital Diseases, Male

Hormones
Pharmacologic Actions
Dutasteride
Neoplasms
Neoplasms by Site
Prostatic Neoplasms
Androgens

ClinicalTrials.gov processed this record on February 08, 2010