Study Assessing The Efficacy And Safety Of Avodart (Dutasteride) At Improving Urinary Symptoms In Men With Prostate Cancer Who Are Undergoing Seed Implantation - Full Text View

Sponsor:	Bay State Clinical Trials, Inc.
Collaborator:	GlaxoSmithKline
Information provided by:	Bay State Clinical Trials, Inc.
ClinicalTrials.gov Identifier:	NCT00805701

Purpose

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 prostate. Avodart works by reducing DHT and prostate size; therefore, the drug may be useful in improving lower urinary tract symptoms (LUTS) such as frequency, urgency, weak stream, and urination difficulty (dysuria), among others, in men with prostate cancer. Avodart may be effective in men with prostate cancer who are being treated with hormonal therapy with one injection of Zolodex (goserelin) followed one month later with a trans-urethral incision of the prostate (TUIP), and three months after that, seed implantation (SI) of the prostate.

The purpose of this study is to test whether Avodart (dutasteride) is effective on LUTS and dysuria in men with localized prostate cancer being treated with single-dose goserelin, TUIP, and interval SI.

Condition	Intervention	Phase
Prostate Cancer	Drug: avodart Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Randomized, Double-Blind, Placebo-Controlled Trial Assessing The Efficacy And Safety Of Dutasteride At Improving Lower Urinary Tract Symptoms In Men With Clinically Localized Prostate Cancer Being Treated With Single-Dose Goserelin, Trans-Urethral Incision Of Prostate, And Interval Brachytherapy

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 Bay State Clinical Trials, Inc.:

Primary Outcome Measures:

the effect of dutasteride on dysuria, voiding and LUTS [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	January 2009
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
0.5mg Avodart: Active Comparator .5mg avodart capsule orally once a day during 13 months	Drug: avodart 0.5 avodart once daily for 13 weeks
Placebo: Placebo Comparator placebo capsule orally daily for 13 months	Drug: Placebo placebo

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. Dutasteride has been shown to significantly decrease intraprostatic DHT in men with localized prostate cancer, and additionally cause apoptosis and regression of some prostate cancers [Andriole, 2004a; Andriole, 2004b]. Furthermore, reduction in tumor volume has also been demonstrated in human prostate tissue [Iczkowski, 2004]. Dutasteride is currently indicated to treat symptomatic BPH in men with enlarged prostates, but is also being studied to reduce the risk of prostate cancer in men at risk (elevated PSA and previous negative biopsy). Dutasteride is clinically useful at improving lower urinary tract symptoms (LUTS) in men with clinically-localized prostate cancer and voiding difficulty being treated with single-dose goserelin, TUIP, and interval SI. [Mitcheson, personal observation].

Eligibility

Ages Eligible for Study:	35 Years to 90 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: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 ≤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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805701

Locations

United States, Massachusetts
Bay State Clinical Trials, Inc.	Recruiting
Watertown, Massachusetts, United States, 02472
Contact: Marina Noble, MD, MPH 617-923-0328 baystate.clinicaltrials@verizon.net

Sponsors and Collaborators

Bay State Clinical Trials, Inc.

GlaxoSmithKline

Investigators

Principal Investigator:

Henry D Mitcheson, MD

Bay State Clinical Trials, Inc.

More Information

No publications provided

Responsible Party:	Bay State Clinical Trials, Inc. ( Henry David Mitcheson, MD )
Study ID Numbers:	047838
Study First Received:	December 5, 2008
Last Updated:	July 20, 2009
ClinicalTrials.gov Identifier:	NCT00805701 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bay State Clinical Trials, Inc.:

prostate
cancer
avodart
dutasteride
mitcheson

Additional relevant MeSH terms:

Dutasteride
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases
Genital Neoplasms, Male

Enzyme Inhibitors
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 05, 2009