Status:
COMPLETED
Study Assessing The Efficacy And Safety Of Avodart (Dutasteride) At Improving Urinary Symptoms In Men With Prostate Cancer Who Are Undergoing Seed Implantation
Lead Sponsor:
Bay State Clinical Trials, Inc.
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Prostate Cancer
Eligibility:
MALE
35-90 years
Phase:
PHASE4
Brief Summary
Avodart (dutasteride) reduces the male hormone (DHT) that leads to prostate growth and stimulates cancerous growth. Avodart is currently approved by the FDA to treat men with symptoms of an enlarged p...
Detailed Description
Dutasteride is an inhibitor of the 5 alpha reductase type I and type II enzymes that convert testosterone to DHT, the male hormone that leads to benign prostate growth and drives malignant growth. Dut...
Eligibility Criteria
Inclusion
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Must be male ≥35 and ≤90 years of age
- Have biopsy proven, localized prostate cancer
- Gleason score ≤ 8
- Clinical stage T1c-T2b
- Serum PSA (prostate specific antigen) ≤10ng/mL within the 12 months period prior to positive prostate biopsy.
- Able to swallow and retain oral medication
- Able and willing to participate in the full duration of the study
- Able to read and write (health outcomes questionnaires are self-administered), understand instructions related to study procedures and give written informed consent.
Exclusion
- Subject has ever been treated for prostate cancer with any of the following:
- Radiotherapy (external beam or brachytherapy)
- Chemotherapy
- Hormonal therapy (e.g., megestrol, medroxyprogesterone, cyproterone, diethyl-stilbestrol (DES)
- Oral glucocorticoids
- Gonadotropin Releasing Hormone (GnRH) analogues (e.g., leuprolide, goserelin) other than the single-dose gosereline given as treatment in this study.
- Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior to visit one
- Current and/or previous use of the following medications:
- Finasteride (Proscar, Propecia), or Dutasteride (Avodart) exposure within 6 months prior to study entry are excluded.
- Any other investigational 5-reductase inhibitors within the past 12 months.
- Anabolic steroids (subject must discontinued for 6 months prior to study entry to be eligible)
- Drugs with antiandrogenic properties within the past 6 months (e.g,. spironolactone, flutamide, bicalutamide, \*cimetidine, \*ketoconazole, progestational agents) \*The use of cimetidine is permitted prior to study entry. The use of topical ketoconazole is permitted prior to and during the study.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00805701
Start Date
January 1 2009
End Date
April 1 2014
Last Update
May 14 2014
Active Locations (1)
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1
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States, 02472