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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


Phase 4
35 Years
90 Years
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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


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].


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 ≤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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

the effect of dutasteride on dysuria, voiding and LUTS

Outcome Time Frame:

16 months

Safety Issue:

Yes

Principal Investigator

Henry D Mitcheson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Bay State Clinical Trials, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

047838

NCT ID:

NCT00805701

Start Date:

January 2009

Completion Date:

February 2014

Related Keywords:

  • Prostate Cancer
  • prostate
  • cancer
  • avodart
  • dutasteride
  • mitcheson
  • Prostatic Neoplasms

Name

Location

Bay State Clinical Trials, Inc.Watertown, Massachusetts  02472