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

Sponsor

Bay State Clinical Trials, Inc. (Other)

Overall Status

Completed

CT.gov ID

NCT00805701

Collaborator

GlaxoSmithKline (Industry)

Enrollment

Location

Arms

62.9

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: avodart Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

the effect of dutasteride on dysuria, voiding and LUTS [16 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 90 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.