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

NCT00805701 | Completed Phase 4

• 1 other identifier: 047838
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate; cancer; avodart; dutasteride; mitcheson

Outcome Measures

Primary Outcomes (1)

• the effect of dutasteride on dysuria, voiding and LUTS

  16 months

Study Arms (2)

0.5mg Avodart

ACTIVE COMPARATOR

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

Drug: avodart

Placebo

PLACEBO COMPARATOR

placebo capsule orally daily for 13 months

Drug: Placebo

Interventions

avodart DRUG

0.5 avodart once daily for 13 weeks

Also known as: dutasteride

0.5mg Avodart

Placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bay State Clinical Trials, Inc.: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Bay State Clinical Trials, Inc.

Watertown, Massachusetts, 02472, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Henry D Mitcheson, MD

  Bay State Clinical Trials, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 10, 2008
• Study Start: January 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

US (1)