Last updated: 11/04/2018 05:21:40

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

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GSK study ID

AVO105948

See study documents

Clinicaltrials.gov ID

See results summary

EudraCT ID

Not applicable

EU CT Number

Not applicable

Trial status

Study complete

Study complete

Overview

Eligibility

Locations

Study documents

Results summary

Plain language summaries

Additional information

Trial overview

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

Trial description: 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).

Primary purpose:

Treatment

Trial design:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Allocation:

Randomized

Primary outcomes:

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

Timeframe: Year 1.5 and Overall (Years 0-3)

Secondary outcomes:

Number of participants with therapeutic progression

Timeframe: Year 1.5 and Overall (Years 0-3)

Number of participants with pathologic progression

Timeframe: Year 1.5 and Overall (Years 0-3)

Participants with at least one post-baseline biopsy with the indicated prostate cancer (PCa) diagnosis

Timeframe: Baseline to Month 18

Participants with at least one post-baseline biopsy with the indicated prostate cancer (PCa) diagnosis for their final biopsy

Timeframe: Years 0-3

Number of cancer-positive cores in a 12-core biopsy

Timeframe: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)

Change from baseline in the number of cancer-positive cores in a 12-core biopsy at Years 1.5, 3, and 0-3

Timeframe: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)

Mean percentage of cancer-positive cores in a 12-core biopsy

Timeframe: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)

Change from baseline in the percentage of cancer-positive cores in a 12-core biopsy at Years 1.5, 3, and 0-3

Timeframe: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)

Cumulative length of cancer tumor core

Timeframe: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)

Change from baseline in the cumulative length of cancer tumor core at Years 1.5, 3, and 0-3

Timeframe: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)

Number of participants with the indicated change from baseline in Gleason score (GS) on repeat biopsy at Year 1.5

Timeframe: Year 1.5

Number of participants with the indicated change from baseline in Gleason score on repeat biopsy at Years 0-3

Timeframe: Years 0-3 (Final Biopsy)

Number of participants with the indicated total Gleason score

Timeframe: Years 0-3 (Final Biopsy)

Number of biopsies with the indicated clinical Tumor Stage at Baseline

Timeframe: Baseline

Number of post-baseline biopsies with the indicated change from Baseline in clinical stage

Timeframe: Months 0-18

Prostate volume (PV) LOCF

Timeframe: Baseline and Years 1.5 and 3

Change from baseline in prostate volume at Years 1.5 and 3

Timeframe: Baseline and Years 1.5 and 3

Percent change from baseline in prostate volume at Years 1.5 and 3

Timeframe: Baseline and Years 1.5 and 3

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

Timeframe: Baseline and Month 3, 6, 12, 18, and 36

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

Timeframe: Baseline and Months 3, 6, 12, 18, and 36

Total MAX-PC Anxiety Subscale Score related to PSA testing

Timeframe: Baseline and Months 3, 6, 12, 18, and 36

Change from Baseline in MAX-PC Anxiety Subscale Score related to PSA testing (LOCF)

Timeframe: Baseline and Months 3, 6, 12, 18, and 36

Total MAX-PC Fear of Recurrence Subscale Score

Timeframe: Baseline and Months 3, 6, 12, 18, and 36

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

Timeframe: Baseline and Months 3, 6, 12, 18, and 36

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

Timeframe: Baseline and Months 18 and 36

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

Timeframe: Baseline and Months 18 and 36

Percent change from Baseline in Total FACT-P Score (LOCF)

Timeframe: Baseline and Months 18 and 36

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

Timeframe: Baseline and Months 18 and 36

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

Timeframe: Baseline and Months 18 and 36

Interventions:

Drug: Dutasteride

Drug: Matching placebo

Enrollment:

302

Primary completion date:

2010-20-07

Observational study model:

Not applicable

Time perspective:

Not applicable

Clinical publications:

Fleshner N, Lucia S, Eure G, Aaron L, Egerdie B, Nandy I, Black L, Rittmaster R. Dutasteride in localised prostate cancer management: the REDEEM randomised, double-blind, placebo-controlled trial. [Lancet]. 2012;379(9821):1103-1111.

Medical condition

Neoplasms, Prostate

Product

dutasteride

Collaborators

GSK

Study date(s)

July 2006 to July 2010

Type

Interventional

Phase

4

Participation criteria

Sex

Male

Age

50 - 80 years

Accepts healthy volunteers

No

Inclusion criteria:
Must be male ≥48 and ≤82 years of age

Inclusion and exclusion criteria

Inclusion 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.

Trial location(s)

Location

Status

Contact us

Location

GSK Investigational Site

Minneapolis, Minnesota, United States

Status

Study Complete

Location

GSK Investigational Site

Beverly Hills, California, United States, 90210

Status

Terminated/Withdrawn

Location

GSK Investigational Site

Bala Cynwyd, Pennsylvania, United States, 19004

Status

Study Complete

Location

GSK Investigational Site

Burlington, Ontario, Canada, L7N 3V2

Status

Study Complete

Location

GSK Investigational Site

Laguna Hills, California, United States, 92653

Status

Study Complete

Location

GSK Investigational Site

Torrance, California, United States, 90506

Status

Study Complete

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Study documents

Clinical study report

Available language(s): English

Download document(s)

Scientific result summary

Available language(s): English

Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status

Study complete

Actual primary completion date

2010-20-07

Actual study completion date

2010-20-07

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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