Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Canadian Urology Research Consortium
With
GlaxoSmithKline
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.
Age
45–80
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
