Prostate Cancer Clinical Trial
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
Verified date | May 2014 |
Source | Bay State Clinical Trials, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 35 Years to 90 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Bay State Clinical Trials, Inc. | Watertown | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Bay State Clinical Trials, Inc. | GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the effect of dutasteride on dysuria, voiding and LUTS | 16 months | Yes |
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