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Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neoplasms, Prostate; Prostate Cancer

Intervention: Dutasteride (Drug); Matching placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

The purpose of this study is to examine the effect of dutasteride on the inhibition of low-risk, localized prostate cancer progression in men who would otherwise receive no active therapy (expectant management).

Clinical Details

Official title: A Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride in Extending the Time to Progression of Low-Risk, Localized Prostate Cancer in Men Who Are Candidates for or Undergoing Expectant Management

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

Primary outcome: Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression

Secondary outcome:

Number of Participants With Therapeutic Progression

Number of Participants With Pathologic Progression

Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis

Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy

Number of Cancer-positive Cores in a 12-core Biopsy

Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3

Mean Percentage of Cancer-positive Cores in a 12-core Biopsy

Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3

Cumulative Length of Cancer Tumor Core

Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3

Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5

Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3

Number of Participants With the Indicated Total Gleason Score

Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline

Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage

Prostate Volume (PV) LOCF

Change From Baseline in Prostate Volume at Years 1.5 and 3

Percent Change From Baseline in Prostate Volume at Years 1.5 and 3

Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)

Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF

Total MAX-PC Anxiety Subscale Score Related to PSA Testing

Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)

Total MAX-PC Fear of Recurrence Subscale Score

Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)

Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score

Change From Baseline in Total FACT-P Score (LOCF)

Percent Change From Baseline in Total FACT-P Score (LOCF)

Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF)

Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF)

Eligibility

Minimum age: 50 Years. Maximum age: 80 Years. Gender(s): Male.

Criteria:

Inclusion criteria:

- Must be male ≥48 and ≤82 years of age

- Have biopsy proven, low-risk, localized prostate cancer and active in expectant

management not more than 14 months. [For the purposes of assessing subject eligibility a diagnostic biopsy must have included at least 10 cores, (< 4 cores positive and <50% of any one core positive) and must have been obtained within 8 months of screening]. If a saturation biopsy was performed (20 or more cores obtained) 2-3 cores are to be positive for prostate cancer and with <50% of any one core positive. Initial diagnosis of T1a/T1b obtained during a Transrectal ultrasound (TURP) is not allowed.

- Gleason score ≤6 [Gleason pattern 4 or above must not be present on any biopsy

(initial or entry)]

- Clinical stage T1c-T2a

- Serum Prostate Specific Antigen (PSA) ≤11ng/mL. If the screening PSA value from the

central laboratory is greater than 11ng/ml, one PSA retest is allowed through the central laboratory

- A life expectancy greater than five years.

- Able to swallow and retain oral medication

- Able and willing to participate in the full 3 years 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,

diethylstilbestrol (DES)

- Oral glucocorticoids

- Gonadotropin-releasing hormone (GnRH) analogues (e. g., leuprolide, goserelin)

- 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 (GI198745, AVODART) exposure within 6

months prior to study entry are excluded.

- Any other investigational 5α-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, metronidazole, progestational agents) NOTE: Use of dietary and herbal supplements (e. g., selenium, Vitamin E, saw palmetto) during the study is discouraged but not prohibited. All dietary and herbal supplement usage will be recorded in the case report form (CRF). *The use of cimetidine is permitted prior to study entry. The use of topical ketoconazole is permitted prior to and during the study.

- Prostate volume >80 cc

- Subject has had prior prostatic surgery including Transurethral needle ablation of

the prostate (TUNA), TURP, Transurethral incision of the prostate (TUIP), laser treatment, thermotherapy, balloon dilatation, prosthesis, and ultrasound ablation within 3 months of enrolment

- Severe Benign Prostatic Hyperplasia (BPH) symptoms as manifested by International

Prostate Symptom Score (IPSS) symptom score (calculated using the first 7 questions only) of ≥25 or >20 if already on alpha blocker therapy.

- Participation in any investigational or marketed drug trial within the 30 days prior

to the first dose of study drug or anytime during the study period.

- Any unstable serious co-existing medical condition(s) including but not limited to

myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.

- Abnormal liver function test (greater than 2 times the upper limit of normal for

alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP]); or bilirubin >1. 5 times the upper limit of normal.

- Serum creatinine >1. 5 times the upper limit of normal.

- History of another malignancy within five years that could affect the diagnosis of

prostate cancer.

- History or current evidence of drug or alcohol abuse within the last 12 months.

- History of any illness (including psychiatric) that, in the opinion of the

investigator, might confound the results of the study or pose additional risk to the subject.

- Known hypersensitivity to any 5α-reductase inhibitor or to any drug chemically

related to dutasteride.

Locations and Contacts

GSK Investigational Site, Little Rock, Arkansas 72211, United States

GSK Investigational Site, Surrey, British Columbia V3V 1N1, Canada

GSK Investigational Site, Victoria, British Columbia V8T 5G1, Canada

GSK Investigational Site, Victoria, British Columbia V8V 3N1, Canada

GSK Investigational Site, Beverly Hills, California 90210, United States

GSK Investigational Site, Laguna Hills, California 92653, United States

GSK Investigational Site, Mission Hills, California 91345, United States

GSK Investigational Site, Modesto, California 95350, United States

GSK Investigational Site, San Bernardino, California 92404, United States

GSK Investigational Site, Torrance, California 90506, United States

GSK Investigational Site, Englewood, Colorado 80113, United States

GSK Investigational Site, Wheat Ridge, Colorado 80033, United States

GSK Investigational Site, New Britain, Connecticut 06052, United States

GSK Investigational Site, Trumbull, Connecticut 06611, United States

GSK Investigational Site, Washington, District of Columbia 20307, United States

GSK Investigational Site, Jacksonville, Florida 32224, United States

GSK Investigational Site, Largo, Florida 33773, United States

GSK Investigational Site, Orlando, Florida 32803, United States

GSK Investigational Site, Roswell, Georgia 30076, United States

GSK Investigational Site, Coeur D'alene, Idaho 83814, United States

GSK Investigational Site, Chicago, Illinois 60612, United States

GSK Investigational Site, Melrose Park, Illinois 60160, United States

GSK Investigational Site, Fort Wayne, Indiana 46825, United States

GSK Investigational Site, Newburgh, Indiana 47630, United States

GSK Investigational Site, Overland Park, Kansas 66211, United States

GSK Investigational Site, Shreveport, Louisiana 71106, United States

GSK Investigational Site, Annapolis, Maryland 21401, United States

GSK Investigational Site, Greenbelt, Maryland 20770, United States

GSK Investigational Site, Watertown, Massachusetts 02472, United States

GSK Investigational Site, Minneapolis, Minnesota, United States

GSK Investigational Site, St. Cloud, Minnesota 56303, United States

GSK Investigational Site, St. Louis, Missouri 63136, United States

GSK Investigational Site, Las Vegas, Nevada 89148, United States

GSK Investigational Site, Fredericton, New Brunswick E3B 5B8, Canada

GSK Investigational Site, Albuquerque, New Mexico 87109, United States

GSK Investigational Site, Albany, New York 12208, United States

GSK Investigational Site, Elmont, New York 11003, United States

GSK Investigational Site, Garden City, New York 11530, United States

GSK Investigational Site, New York, New York 10016, United States

GSK Investigational Site, Orchard Park, New York 14127, United States

GSK Investigational Site, Syracuse, New York 13210, United States

GSK Investigational Site, Greensboro, North Carolina 27403, United States

GSK Investigational Site, Salisbury, North Carolina 28144, United States

GSK Investigational Site, Winston-salem, North Carolina 27103, United States

GSK Investigational Site, Columbus, Ohio 43214, United States

GSK Investigational Site, Barrie, Ontario L4M 7G1, Canada

GSK Investigational Site, Brantford, Ontario N3R 4N3, Canada

GSK Investigational Site, Burlington, Ontario L7S 1V2, Canada

GSK Investigational Site, Burlington, Ontario L7N 3V2, Canada

GSK Investigational Site, Guelph, Ontario N1H 5J1, Canada

GSK Investigational Site, Kitchener, Ontario N2N 2B9, Canada

GSK Investigational Site, Oakville, Ontario L6H 3P1, Canada

GSK Investigational Site, Scarborough, Ontario M1P 2T7, Canada

GSK Investigational Site, Toronto, Ontario M4C 5T2, Canada

GSK Investigational Site, Toronto, Ontario M5G 2M9, Canada

GSK Investigational Site, Toronto, Ontario M6A 3B5, Canada

GSK Investigational Site, Springfield, Oregon 97477, United States

GSK Investigational Site, Bala Cynwyd, Pennsylvania 19004, United States

GSK Investigational Site, Lancaster, Pennsylvania 17604, United States

GSK Investigational Site, Philadelphia, Pennsylvania 19107, United States

GSK Investigational Site, Chicoutimi, Quebec G7H 4A3, Canada

GSK Investigational Site, Greenfield Park, Quebec J4V 2H3, Canada

GSK Investigational Site, Laval, Quebec H7G 2E6, Canada

GSK Investigational Site, Montreal, Quebec H3G 1A4, Canada

GSK Investigational Site, Pointe-claire, Quebec H9R 4S3, Canada

GSK Investigational Site, Quebec City, Quebec G1R 2J6, Canada

GSK Investigational Site, Trois Rivieres, Quebec G9A 3V7, Canada

GSK Investigational Site, Memphis, Tennessee 38119, United States

GSK Investigational Site, Nashville, Tennessee 37232, United States

GSK Investigational Site, San Antonio, Texas 78229, United States

GSK Investigational Site, Salt Lake City, Utah 84107, United States

GSK Investigational Site, Richmond, Virginia 23235, United States

GSK Investigational Site, Virginia Beach, Virginia 23455, United States

GSK Investigational Site, Williamsburg, Virginia 23185, United States

GSK Investigational Site, Seattle, Washington 98166, United States

GSK Investigational Site, Seattle, Washington 98101, United States

GSK Investigational Site, Spokane, Washington 99202, United States

Additional Information

Starting date: July 2006
Last updated: March 15, 2012

Page last updated: August 20, 2015

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