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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
avodart
Placebo
Sponsored by
Bay State Clinical Trials, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate, cancer, avodart, dutasteride, mitcheson

Eligibility Criteria

35 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Bay State Clinical Trials, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

0.5mg Avodart

Placebo

Arm Description

.5mg avodart capsule orally once a day during 13 months

placebo capsule orally daily for 13 months

Outcomes

Primary Outcome Measures

the effect of dutasteride on dysuria, voiding and LUTS

Secondary Outcome Measures

Full Information

First Posted
December 5, 2008
Last Updated
May 12, 2014
Sponsor
Bay State Clinical Trials, Inc.
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00805701
Brief Title
Study Assessing The Efficacy And Safety Of Avodart (Dutasteride) At Improving Urinary Symptoms In Men With Prostate Cancer Who Are Undergoing Seed Implantation
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bay State Clinical Trials, Inc.
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate, cancer, avodart, dutasteride, mitcheson

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.5mg Avodart
Arm Type
Active Comparator
Arm Description
.5mg avodart capsule orally once a day during 13 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo capsule orally daily for 13 months
Intervention Type
Drug
Intervention Name(s)
avodart
Other Intervention Name(s)
dutasteride
Intervention Description
0.5 avodart once daily for 13 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
the effect of dutasteride on dysuria, voiding and LUTS
Time Frame
16 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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 (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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry D Mitcheson, MD
Organizational Affiliation
Bay State Clinical Trials, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bay State Clinical Trials, Inc.
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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