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

2016. november 30. frissítette: GlaxoSmithKline

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

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).

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

302

Fázis

  • 4. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

  • Egyesült Államok
    • Arkansas
      • Little Rock, Arkansas, Egyesült Államok, 72211
        • GSK Investigational Site
    • California
      • Beverly Hills, California, Egyesült Államok, 90210
        • GSK Investigational Site
      • Laguna Hills, California, Egyesült Államok, 92653
        • GSK Investigational Site
      • Mission Hills, California, Egyesült Államok, 91345
        • GSK Investigational Site
      • Modesto, California, Egyesült Államok, 95350
        • GSK Investigational Site
      • San Bernardino, California, Egyesült Államok, 92404
        • GSK Investigational Site
      • Torrance, California, Egyesült Államok, 90506
        • GSK Investigational Site
    • Colorado
      • Englewood, Colorado, Egyesült Államok, 80113
        • GSK Investigational Site
      • Wheat Ridge, Colorado, Egyesült Államok, 80033
        • GSK Investigational Site
    • Connecticut
      • New Britain, Connecticut, Egyesült Államok, 06052
        • GSK Investigational Site
      • Trumbull, Connecticut, Egyesült Államok, 06611
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, Egyesült Államok, 20307
        • GSK Investigational Site
    • Florida
      • Jacksonville, Florida, Egyesült Államok, 32224
        • GSK Investigational Site
      • Largo, Florida, Egyesült Államok, 33773
        • GSK Investigational Site
      • Orlando, Florida, Egyesült Államok, 32803
        • GSK Investigational Site
    • Georgia
      • Roswell, Georgia, Egyesült Államok, 30076
        • GSK Investigational Site
    • Idaho
      • Coeur D'Alene, Idaho, Egyesült Államok, 83814
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Egyesült Államok, 60612
        • GSK Investigational Site
      • Melrose Park, Illinois, Egyesült Államok, 60160
        • GSK Investigational Site
    • Indiana
      • Fort Wayne, Indiana, Egyesült Államok, 46825
        • GSK Investigational Site
      • Newburgh, Indiana, Egyesült Államok, 47630
        • GSK Investigational Site
    • Kansas
      • Overland Park, Kansas, Egyesült Államok, 66211
        • GSK Investigational Site
    • Louisiana
      • Shreveport, Louisiana, Egyesült Államok, 71106
        • GSK Investigational Site
    • Maryland
      • Annapolis, Maryland, Egyesült Államok, 21401
        • GSK Investigational Site
      • Greenbelt, Maryland, Egyesült Államok, 20770
        • GSK Investigational Site
    • Massachusetts
      • Watertown, Massachusetts, Egyesült Államok, 02472
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, Egyesült Államok
        • GSK Investigational Site
      • St. Cloud, Minnesota, Egyesült Államok, 56303
        • GSK Investigational Site
    • Mississippi
      • Jackson, Mississippi, Egyesült Államok, 39202
        • GSK Investigational Site
    • Missouri
      • St. Louis, Missouri, Egyesült Államok, 63136
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, Egyesült Államok, 89148
        • GSK Investigational Site
    • New Jersey
      • Marlton, New Jersey, Egyesült Államok, 08053
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, Egyesült Államok, 87109
        • GSK Investigational Site
    • New York
      • Albany, New York, Egyesült Államok, 12208
        • GSK Investigational Site
      • Elmont, New York, Egyesült Államok, 11003
        • GSK Investigational Site
      • Garden City, New York, Egyesült Államok, 11530
        • GSK Investigational Site
      • New York, New York, Egyesült Államok, 10016
        • GSK Investigational Site
      • Orchard Park, New York, Egyesült Államok, 14127
        • GSK Investigational Site
      • Syracuse, New York, Egyesült Államok, 13210
        • GSK Investigational Site
    • North Carolina
      • Greensboro, North Carolina, Egyesült Államok, 27403
        • GSK Investigational Site
      • Salisbury, North Carolina, Egyesült Államok, 28144
        • GSK Investigational Site
      • Winston-Salem, North Carolina, Egyesült Államok, 27103
        • GSK Investigational Site
    • Ohio
      • Columbus, Ohio, Egyesült Államok, 43214
        • GSK Investigational Site
    • Oregon
      • Springfield, Oregon, Egyesült Államok, 97477
        • GSK Investigational Site
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, Egyesült Államok, 19004
        • GSK Investigational Site
      • Lancaster, Pennsylvania, Egyesült Államok, 17604
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Egyesült Államok, 19107
        • GSK Investigational Site
    • Tennessee
      • Memphis, Tennessee, Egyesült Államok, 38119
        • GSK Investigational Site
      • Nashville, Tennessee, Egyesült Államok, 37232
        • GSK Investigational Site
    • Texas
      • San Antonio, Texas, Egyesült Államok, 78229
        • GSK Investigational Site
      • Temple, Texas, Egyesült Államok, 76508
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, Egyesült Államok, 84107
        • GSK Investigational Site
    • Virginia
      • Richmond, Virginia, Egyesült Államok, 23235
        • GSK Investigational Site
      • Virginia Beach, Virginia, Egyesült Államok, 23455
        • GSK Investigational Site
      • Williamsburg, Virginia, Egyesült Államok, 23185
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, Egyesült Államok, 98101
        • GSK Investigational Site
      • Seattle, Washington, Egyesült Államok, 98166
        • GSK Investigational Site
      • Spokane, Washington, Egyesült Államok, 99202
        • GSK Investigational Site
  • Kanada
    • British Columbia
      • Surrey, British Columbia, Kanada, V3V 1N1
        • GSK Investigational Site
      • Victoria, British Columbia, Kanada, V8T 5G1
        • GSK Investigational Site
      • Victoria, British Columbia, Kanada, V8V 3N1
        • GSK Investigational Site
    • New Brunswick
      • Fredericton, New Brunswick, Kanada, E3B 5B8
        • GSK Investigational Site
    • Ontario
      • Barrie, Ontario, Kanada, L4M 7G1
        • GSK Investigational Site
      • Brampton, Ontario, Kanada, L6T 3J1
        • GSK Investigational Site
      • Brantford, Ontario, Kanada, N3R 4N3
        • GSK Investigational Site
      • Burlington, Ontario, Kanada, L7N 3V2
        • GSK Investigational Site
      • Burlington, Ontario, Kanada, L7S 1V2
        • GSK Investigational Site
      • Guelph, Ontario, Kanada, N1H 5J1
        • GSK Investigational Site
      • Kitchener, Ontario, Kanada, N2N 2B9
        • GSK Investigational Site
      • North Bay, Ontario, Kanada, P1B 4Z2
        • GSK Investigational Site
      • Oakville, Ontario, Kanada, L6H 3P1
        • GSK Investigational Site
      • Scarborough, Ontario, Kanada, M1P 2T7
        • GSK Investigational Site
      • Toronto, Ontario, Kanada, M5G 2M9
        • GSK Investigational Site
      • Toronto, Ontario, Kanada, M6A 3B5
        • GSK Investigational Site
      • Toronto, Ontario, Kanada, M4C 5T2
        • GSK Investigational Site
    • Quebec
      • Chicoutimi, Quebec, Kanada, G7H 4A3
        • GSK Investigational Site
      • Greenfield Park, Quebec, Kanada, J4V 2H3
        • GSK Investigational Site
      • Laval, Quebec, Kanada, H7G 2E6
        • GSK Investigational Site
      • Montreal, Quebec, Kanada, H3G 1A4
        • GSK Investigational Site
      • Pointe-Claire, Quebec, Kanada, H9R 4S3
        • GSK Investigational Site
      • Quebec City, Quebec, Kanada, G1R 2J6
        • GSK Investigational Site
      • Trois Rivieres, Quebec, Kanada, G9A 3V7
        • GSK Investigational Site

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

50 év (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Férfi

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Kettős

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Placebo Comparator: Placebo
Megfelelő placebo
Drog: Megfelelő placebo
Megfelelő placebo
Aktív összehasonlító: Dutaszterid
Dutaszterid 0,5 mg
Drog: Dutasteride
Dutasteride 0.5mg

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
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
Időkeret: Year 1.5 and Overall (Years 0-3)
PC progression (prog.) was defined as the earliest occurrence of primary therapy, also referred to as therapeutic prog., for PC (prostatectomy/radiation/hormonal therapy); or pathological prog., defined as 1 of the following: >=4 cores involved; >=50% of any 1 core involved; or a Gleason pattern of >=4 as a result of any on-study/for-cause biopsy. Primary Gleason grade is assigned to the most common tumor pattern; a second grade to the next most common tumor pattern. The two grades are added together to get a score. Gleason grade= 1-5; Gleason score=2-10; 5 and 10 indicate worst prognosis.
Year 1.5 and Overall (Years 0-3)

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Number of Participants With Therapeutic Progression
Időkeret: Year 1.5 and Overall (Years 0-3)
Primary therapy, also referred to as therapeutic progression, for prostate cancer can be one of the following: prostatectomy, radiation, or hormonal therapy.
Year 1.5 and Overall (Years 0-3)
Number of Participants With Pathologic Progression
Időkeret: Year 1.5 and Overall (Years 0-3)
Pathological progression is defined as one of the following: >=4 cores involved; >=50% of any 1 core involved; or a Gleason pattern of >=4 as a result of any on-study/for-cause biopsy. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) were used to grade tumors. A primary grade is assigned to the most common tumor pattern, and a second grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade=1-5, with 5 having the worst prognosis. The Gleason score=2-10, with 10 having the worst prognosis.
Year 1.5 and Overall (Years 0-3)
Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis
Időkeret: Baseline to Month 18
All participants were required by protocol to undergo a transrectal ultrasound (TRUS)-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. All biopsies were reviewed and analyzed by a central pathologist.
Baseline to Month 18
Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy
Időkeret: Years 0-3
All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.
Years 0-3
Number of Cancer-positive Cores in a 12-core Biopsy
Időkeret: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. . The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.
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
Időkeret: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Change from baseline was calculated as the number of cancer-positive cores at post-baseline biopsy minus the number of cancer-positive cores at baseline.
Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Mean Percentage of Cancer-positive Cores in a 12-core Biopsy
Időkeret: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsies (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. The sum of cancer positive cores and the sum of evaluated cores were used to compute the percentage (100* number of positive cores/number of evaluated cores).
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
Időkeret: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. (100 * number of positive cores/number of evaluated cores).
Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Cumulative Length of Cancer Tumor Core
Időkeret: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Tumor length is calculated as the number of cores (12) * total tumor length/number of evaluated cores.
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
Időkeret: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist.
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
Időkeret: Year 1.5
The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS >6).
Year 1.5
Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3
Időkeret: Years 0-3 (Final Biopsy)
The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS >6).
Years 0-3 (Final Biopsy)
Number of Participants With the Indicated Total Gleason Score
Időkeret: Years 0-3 (Final Biopsy)
All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade the tumor. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a secondary grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade ranges from 1 to 5, with 5 having the worst prognosis. The Gleason score ranges from 2 to 10, with 10 having the worst prognosis.
Years 0-3 (Final Biopsy)
Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline
Időkeret: Baseline
All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for clinical tumor staging were used. T1c = tumor identified by needle biopsy (e.g., because of elevated prostate-specific antigen [PSA]); T2 = tumor confined within the prostate; T2a = tumor involves one-half of one lobe, but not both lobes of the prostate.
Baseline
Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage
Időkeret: Months 0-18
All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The National Comprehensive Network (NCCN), 2005 clinical practices guidelines in Oncology-prostate cancer were used for clinical tumor staging. T0: no evidence of primary tumor; T1: clinically inapparent tumor, neither palpable nor visible by imaging; T2: tumor confined within the prostate; T3: tumor extends through the prostate capsule; T4: tumor is fixed or invades adjacent structures other than seminal vesicles. A clinical stage of T0 in post-baseline biopsies has been interpreted as "No Worsening."
Months 0-18
Prostate Volume (PV) LOCF
Időkeret: Baseline and Years 1.5 and 3

Prostate volume was determined at baseline, at Year 1.5, and at Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:

π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements.
Baseline and Years 1.5 and 3
Change From Baseline in Prostate Volume at Years 1.5 and 3
Időkeret: Baseline and Years 1.5 and 3

Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:

π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment was unacceptable for the on-study prostate volume measurements.
Baseline and Years 1.5 and 3
Percent Change From Baseline in Prostate Volume at Years 1.5 and 3
Időkeret: Baseline and Years 1.5 and 3

Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:

π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements.
Baseline and Years 1.5 and 3
Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)
Időkeret: Baseline and Month 3, 6, 12, 18, and 36
The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.
Baseline and Month 3, 6, 12, 18, and 36
Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF
Időkeret: Baseline and Months 3, 6, 12, 18, and 36
The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.
Baseline and Months 3, 6, 12, 18, and 36
Total MAX-PC Anxiety Subscale Score Related to PSA Testing
Időkeret: Baseline and Months 3, 6, 12, 18, and 36
The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; "I have been so anxious about my PSA test that I have thought about delaying it.", "I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test.", "I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate." A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9.
Baseline and Months 3, 6, 12, 18, and 36
Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)
Időkeret: Baseline and Months 3, 6, 12, 18, and 36
The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; "I have been so anxious about my PSA test that I have thought about delaying it.", "I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test.", "I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate." A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9.
Baseline and Months 3, 6, 12, 18, and 36
Total MAX-PC Fear of Recurrence Subscale Score
Időkeret: Baseline and Months 3, 6, 12, 18, and 36
The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; "Because cancer is unpredictable, I feel I cannot plan for the future.", "My fear of having my cancer getting worse gets in the way of my enjoying life.", "I am afraid of my cancer getting worse.", "I am more nervous since I was diagnosed with prostate cancer." A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12.
Baseline and Months 3, 6, 12, 18, and 36
Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)
Időkeret: Baseline and Months 3, 6, 12, 18, and 36
The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; "Because cancer is unpredictable, I feel I cannot plan for the future.", "My fear of having my cancer getting worse gets in the way of my enjoying life.", "I am afraid of my cancer getting worse.", "I am more nervous since I was diagnosed with prostate cancer." A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12.
Baseline and Months 3, 6, 12, 18, and 36
Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score
Időkeret: Baseline and Months 18 and 36
The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better quality of life.
Baseline and Months 18 and 36
Change From Baseline in Total FACT-P Score (LOCF)
Időkeret: Baseline and Months 18 and 36
The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.
Baseline and Months 18 and 36
Percent Change From Baseline in Total FACT-P Score (LOCF)
Időkeret: Baseline and Months 18 and 36
The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.
Baseline and Months 18 and 36
Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF)
Időkeret: Baseline and Months 18 and 36
The FACT-P Physical Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; "I have a lack of energy.", "I have nausea.", "Because of my physical condition, I have trouble meeting the needs of my family.", "I have pain.", "I am bothered by side effects of treatment.", "I feel ill.", "I am forced to spend time in bed." The score for each question ranges from 0 to 4; a lower score indicates better physical well-being. The total FACT-P score thus ranges from 0 to156; a higher score indicates a better quality of life.
Baseline and Months 18 and 36
Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF)
Időkeret: Baseline and Months 18 and 36
The FACT-P Social Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; "I feel close to my friends.", "I get emotional support from my family.", "I get support from my friends.", "My family has accepted my illness.", "I am satisfied with family communication about my illness.", "I feel close to my partner (or the person who is my main support).", "I am satisfied with my sex life." The score for each question ranges from 0 to 4; a higher score indicates better social well-being. The total FACT-P score thus ranges from 0 to 156.
Baseline and Months 18 and 36

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

GlaxoSmithKline

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Hasznos linkek

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2006. július 1.

Elsődleges befejezés (Tényleges)

2010. március 1.

A tanulmány befejezése (Tényleges)

2010. július 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2006. augusztus 11.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2006. augusztus 11.

Első közzététel (Becslés)

2006. augusztus 15.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Becslés)

2017. január 18.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2016. november 30.

Utolsó ellenőrzés

2016. november 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • AVO105948

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

IGEN

IPD terv leírása

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Tanulmányi adatok/dokumentumok

  1. Statisztikai elemzési terv
    Információs azonosító: AVO105948
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register
  2. Jegyzetekkel ellátott esetjelentési űrlap
    Információs azonosító: AVO105948
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register
  3. Tanulmányi Protokoll
    Információs azonosító: AVO105948
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register
  4. Adatkészlet specifikáció
    Információs azonosító: AVO105948
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register
  5. Klinikai vizsgálati jelentés
    Információs azonosító: AVO105948
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register
  6. Tájékozott hozzájárulási űrlap
    Információs azonosító: AVO105948
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register
  7. Egyéni résztvevő adatkészlet
    Információs azonosító: AVO105948
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Klinikai vizsgálatok a Neoplazmák, prosztata

Klinikai vizsgálatok a Megfelelő placebo

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Ritka betegségek

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Helyek

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