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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ClinicalTrials.gov Identifier: NCT00805701 |
Recruitment Status :
Completed
First Posted : December 10, 2008
Last Update Posted : May 14, 2014
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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 |
Study Type : | Interventional (Clinical Trial) |
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 : | January 2009 |
Actual Primary Completion Date : | April 2014 |
Actual Study Completion Date : | April 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 0.5mg Avodart
.5mg avodart capsule orally once a day during 13 months
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Drug: avodart
0.5 avodart once daily for 13 weeks
Other Name: dutasteride |
Placebo Comparator: Placebo
placebo capsule orally daily for 13 months
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Drug: Placebo
placebo |
- the effect of dutasteride on dysuria, voiding and LUTS [ Time Frame: 16 months ]

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Ages Eligible for Study: | 35 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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:
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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
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805701
United States, Massachusetts | |
Bay State Clinical Trials, Inc. | |
Watertown, Massachusetts, United States, 02472 |
Principal Investigator: | Henry D Mitcheson, MD | Bay State Clinical Trials, Inc. |
Responsible Party: | Bay State Clinical Trials, Inc. |
ClinicalTrials.gov Identifier: | NCT00805701 |
Other Study ID Numbers: |
047838 |
First Posted: | December 10, 2008 Key Record Dates |
Last Update Posted: | May 14, 2014 |
Last Verified: | May 2014 |
prostate cancer avodart dutasteride mitcheson |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Dutasteride |
5-alpha Reductase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |