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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Placebo; Drug: avodart

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].

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
      • Bay State Clinical Trials, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:A subject will be eligible for inclusion in this study only if all of the following criteria apply:

1. Must be male ≥35 and ≤90 years of age
2. Have biopsy proven, localized prostate cancer
3. Gleason score ≤ 8
4. Clinical stage T1c-T2b
5. Serum PSA (prostate specific antigen) ≤10ng/mL within the 12 months period prior to positive prostate biopsy.
6. Able to swallow and retain oral medication
7. Able and willing to participate in the full duration of the study
8. Able to read and write (health outcomes questionnaires are self-administered), understand instructions related to study procedures and give written informed consent.

Exclusion Criteria:

1. 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.
2. Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior to visit one

3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 0.5mg Avodart; .5mg avodart capsule orally once a day during 13 months	Drug: avodart; 0.5 avodart once daily for 13 weeks; Other Names: dutasteride
Placebo Comparator: Placebo; placebo capsule orally daily for 13 months	Drug: Placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the effect of dutasteride on dysuria, voiding and LUTS	16 months

Collaborators and Investigators

• Sponsor: Bay State Clinical Trials, Inc.
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Henry D Mitcheson, MD, Bay State Clinical Trials, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: December 5, 2008
• First Submitted That Met QC Criteria: December 9, 2008
• First Posted (Estimate): December 10, 2008

Study Record Updates

• Last Update Posted (Estimate): May 14, 2014
• Last Update Submitted That Met QC Criteria: May 12, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: cancer; prostate; avodart; dutasteride; mitcheson
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Dutasteride
• Other Study ID Numbers: 047838

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No