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

• ClinicalTrials.gov Identifier: NCT00805701
• Recruitment Status: Completed
• First Posted: December 10, 2008
• Last Update Posted: May 14, 2014
• Sponsor: Bay State Clinical Trials, Inc.
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): Bay State Clinical Trials, Inc.

Tracking Information

• First Submitted Date: December 5, 2008
• First Posted Date: December 10, 2008
• Last Update Posted Date: May 14, 2014
• Study Start Date: January 2009
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 9, 2008): the effect of dutasteride on dysuria, voiding and LUTS [ Time Frame: 16 months ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00805701 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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].
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Prostate Cancer

Intervention

• Drug: avodart
  0.5 avodart once daily for 13 weeks
  Other Name: dutasteride
• Drug: Placebo
  placebo

Study Arms

• Active Comparator: 0.5mg Avodart
  .5mg avodart capsule orally once a day during 13 months
  Intervention: Drug: avodart
• Placebo Comparator: Placebo
  placebo capsule orally daily for 13 months
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 9, 2008): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 2014
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 35 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00805701
• Other Study ID Numbers: 047838
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Bay State Clinical Trials, Inc.
• Study Sponsor: Bay State Clinical Trials, Inc.
• Collaborators: GlaxoSmithKline

Investigators

• Principal Investigator: Henry D Mitcheson, MD; Bay State Clinical Trials, Inc.

• PRS Account: Bay State Clinical Trials, Inc.
• Verification Date: May 2014