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, November 2007

Sponsors and Collaborators:	Canadian Urology Research Consortium 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 Drug: placebo Drug: dutasteride	Phase II Phase III

MedlinePlus related topics:

Cancer Prostate Cancer

ChemIDplus related topics:

Dutasteride

U.S. FDA Resources

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

Further study details as provided by Canadian Urology Research Consortium:

Primary Outcome Measures:

Serum PSA [ Time Frame: 2 Years ]
prolong the duration of the off treatment interval and possibly increase th duration of androgen dependency [ Time Frame: 24 months ]

Estimated Enrollment:	100
Study Start Date:	March 2007
Estimated Study Completion Date:	March 2010

Arms	Assigned Interventions
dutasteride: Placebo Comparator	Drug: Dutasteride dutasteride 0.5mg capsule daily Drug: placebo placebo capsule daily Drug: dutasteride 0.5mg capsule daily

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 4804673	laurence.klotz@sunnybrook.ca

Contact: Larry S Goldenbeerg, MD

Locations


Canada, Ontario
	Sunnybrook Health Science	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

Study ID Numbers:	CURC/CUOG-AVIAS-0601
First Received:	November 5, 2007
Last Updated:	November 5, 2007
ClinicalTrials.gov Identifier:	NCT00553878
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dutasteride

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008