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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dutasteride | Active Comparator | Dutasteride 0.5mg |
|
| Placebo | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dutasteride | Drug | Dutasteride 0.5mg |
| |
| Matching placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Therapeutic Progression | 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 |
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Inclusion criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Little Rock | Arkansas | 72211 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22277570 | Background | Fleshner NE, Lucia MS, Egerdie B, Aaron L, Eure G, Nandy I, Black L, Rittmaster RS. Dutasteride in localised prostate cancer management: the REDEEM randomised, double-blind, placebo-controlled trial. Lancet. 2012 Mar 24;379(9821):1103-11. doi: 10.1016/S0140-6736(11)61619-X. Epub 2012 Jan 24. | |
| 25988518 | Derived |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| AVO105948 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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A completed participant is defined as one who completed the 36-month treatment phase of the study and the 4-month safety follow-up phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Matching Placebo 0.5 mg Once Daily | Matching placebo 0.5 milligrams (mg) administered orally once daily for 156 weeks |
| FG001 | Dutasteride 0.5 mg Once Daily | Dutasteride 0.5 mg administered orally once daily for 156 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Matching placebo |
|
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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) | 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 | 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) | 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 | 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) | 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) | 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) | 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) | 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 |
| 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 D.C. | 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 | Saint Cloud | Minnesota | 56303 | United States |
| GSK Investigational Site | Jackson | Mississippi | 39202 | United States |
| GSK Investigational Site | St Louis | Missouri | 63136 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89148 | United States |
| GSK Investigational Site | Marlton | New Jersey | 08053 | United States |
| 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 | 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 | 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 | Temple | Texas | 76508 | 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 | 98101 | United States |
| GSK Investigational Site | Seattle | Washington | 98166 | United States |
| GSK Investigational Site | Spokane | Washington | 99202 | 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 | Fredericton | New Brunswick | E3B 5B8 | Canada |
| GSK Investigational Site | Barrie | Ontario | L4M 7G1 | Canada |
| GSK Investigational Site | Brampton | Ontario | L6T 3J1 | Canada |
| GSK Investigational Site | Brantford | Ontario | N3R 4N3 | Canada |
| GSK Investigational Site | Burlington | Ontario | L7N 3V2 | Canada |
| GSK Investigational Site | Burlington | Ontario | L7S 1V2 | Canada |
| GSK Investigational Site | Guelph | Ontario | N1H 5J1 | Canada |
| GSK Investigational Site | Kitchener | Ontario | N2N 2B9 | Canada |
| GSK Investigational Site | North Bay | Ontario | P1B 4Z2 | Canada |
| GSK Investigational Site | Oakville | Ontario | L6H 3P1 | Canada |
| GSK Investigational Site | Scarborough Village | 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 | 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 | Québec | Quebec | G1R 2J6 | Canada |
| GSK Investigational Site | Trois-Rivières | Quebec | G9A 3V7 | Canada |
| Moreira DM, Fleshner NE, Freedland SJ. Baseline Perineural Invasion is Associated with Shorter Time to Progression in Men with Prostate Cancer Undergoing Active Surveillance: Results from the REDEEM Study. J Urol. 2015 Nov;194(5):1258-63. doi: 10.1016/j.juro.2015.04.113. Epub 2015 May 16. |
For additional information about this study please refer to the GSK Clinical Study Register |
| AVO105948 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVO105948 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVO105948 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVO105948 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVO105948 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVO105948 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Matching Placebo 0.5 mg Once Daily | Matching placebo 0.5 mg administered orally once daily for 156 weeks |
| BG001 | Dutasteride 0.5 mg Once Daily | Dutasteride 0.5 mg administered orally once daily for 156 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Gender | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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 | 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. | ITT Population: all participants randomized to study treatment. Some participants dropped out of the study prior to meeting the primary endpoint for reasons other than disease progression or refused to have a biopsy performed. | Posted | Number | participants | Year 1.5 and Overall (Years 0-3) |
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| Secondary | Number of Participants With Therapeutic Progression | Primary therapy, also referred to as therapeutic progression, for prostate cancer can be one of the following: prostatectomy, radiation, or hormonal therapy. | ITT Population | Posted | Number | participants | Year 1.5 and Overall (Years 0-3) |
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| Secondary | Number of Participants With Pathologic Progression | 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. | ITT Population. As the study progressed, participants dropped out of the study prior to meeting the primary endpoint for reasons other than disease progression or refused to have a biopsy performed. | Posted | Number | participants | Year 1.5 and Overall (Years 0-3) |
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| Secondary | Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis | 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. | ITT Population. As the study progressed, participants dropped out of the study. | Posted | Number | participants | Baseline to Month 18 |
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| Secondary | Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their 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. 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. | ITT Population. As the study progressed, participants dropped out of the study. | Posted | Number | participants | Years 0-3 |
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| Secondary | Number of Cancer-positive Cores in a 12-core 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. | ITT Population. As the study progressed, participants dropped out of the study. | Posted | Mean | Standard Deviation | cores | Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) |
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| Secondary | Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 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. 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. | ITT Population. As the study progressed, participants dropped out of the study. | Posted | Mean | Standard Deviation | cores | Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) |
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| Secondary | Mean Percentage of Cancer-positive Cores in a 12-core 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). | ITT Population. As the study progressed, participants dropped out of the study. | Posted | Mean | Standard Deviation | percentage of cores | Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) |
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| Secondary | Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 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. All biopsies were reviewed and analyzed by a central pathologist. (100 * number of positive cores/number of evaluated cores). | ITT Population. As the study progressed, participants dropped out of the study. | Posted | Mean | Standard Deviation | percentage of cores | Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) |
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| Secondary | Cumulative Length of Cancer Tumor Core | 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. | ITT Population. As the study progressed, participants dropped out of the study. | Posted | Mean | Standard Deviation | millimeters | Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) |
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| Secondary | Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 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. All biopsies were reviewed and analyzed by a central pathologist. | ITT Population. As the study progressed, participants dropped out of the study. | Posted | Mean | Standard Deviation | millimeters | Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) |
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| Secondary | Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at 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). | ITT Population. As the study progressed, participants dropped out of the study. | Posted | Number | participants | Year 1.5 |
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| Secondary | Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3 | 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). | ITT Population. As the study progressed, participants dropped out of the study. | Posted | Number | participants | Years 0-3 (Final Biopsy) |
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| Secondary | Number of Participants With the Indicated Total Gleason Score | 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. | ITT Population. As the study progressed, participants dropped out of the study. | Posted | Number | participants | Years 0-3 (Final Biopsy) |
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| Secondary | Number of Biopsies With the Indicated Clinical Tumor Stage at 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. | ITT Population | Posted | Number | biopsies | Baseline |
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| Secondary | Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage | 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." | ITT Population. As the study progressed, participants dropped out of the study. | Posted | Number | biopsies | Months 0-18 |
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| Secondary | Prostate Volume (PV) LOCF | 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. | ITT Population. As the study progressed, participants dropped out of the study. Last observation carried forward (LOCF) was used. | Posted | Mean | Standard Deviation | cubic centimeters (cc) | Baseline and Years 1.5 and 3 |
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| Secondary | Change From Baseline in Prostate Volume at 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. | ITT Population. As the study progressed, participants dropped out of the study. | Posted | Mean | Standard Deviation | cc | Baseline and Years 1.5 and 3 |
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| Secondary | Percent Change From Baseline in Prostate Volume at 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. | ITT Population. As the study progressed, participants dropped out of the study. | Posted | Mean | Standard Deviation | percent change | Baseline and Years 1.5 and 3 |
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| Secondary | Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) | 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. | ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire. | Posted | Mean | Standard Deviation | points on a scale | Baseline and Month 3, 6, 12, 18, and 36 |
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| Secondary | Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF | 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. | ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire. | Posted | Mean | Standard Deviation | points on a scale | Baseline and Months 3, 6, 12, 18, and 36 |
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| Secondary | Total MAX-PC Anxiety Subscale Score Related to PSA Testing | 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. | ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire. | Posted | Mean | Standard Deviation | points on a scale | Baseline and Months 3, 6, 12, 18, and 36 |
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| Secondary | Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF) | 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. | ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire. | Posted | Mean | Standard Deviation | points on a scale | Baseline and Months 3, 6, 12, 18, and 36 |
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| Secondary | Total MAX-PC Fear of Recurrence Subscale Score | 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. | ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire. | Posted | Mean | Standard Deviation | points on a scale | Baseline and Months 3, 6, 12, 18, and 36 |
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| Secondary | Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF) | 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. | ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire. | Posted | Mean | Standard Deviation | points on a scale | Baseline and Months 3, 6, 12, 18, and 36 |
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| Secondary | Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score | 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. | ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire. | Posted | Mean | Standard Deviation | points on a scale | Baseline and Months 18 and 36 |
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| Secondary | Change From Baseline in Total FACT-P Score (LOCF) | 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. | ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire. | Posted | Mean | Standard Deviation | points on a scale | Baseline and Months 18 and 36 |
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| Secondary | Percent Change From Baseline in Total FACT-P Score (LOCF) | 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. | ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire. | Posted | Mean | Standard Deviation | points on a scale | Baseline and Months 18 and 36 |
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| Secondary | Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF) | 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. | ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire. | Posted | Mean | Standard Deviation | points on a scale | Baseline and Months 18 and 36 |
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| Secondary | Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF) | 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. | ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire. | Posted | Mean | Standard Deviation | points on a scale | Baseline and Months 18 and 36 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Matching Placebo 0.5 mg Once Daily | Matching placebo 0.5 mg administered orally once daily for 156 weeks | 23 | 155 | 67 | 155 | ||
| EG001 | Dutasteride 0.5 mg Once Daily | Dutasteride 0.5 mg administered orally once daily for 156 weeks | 22 | 147 | 56 | 147 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | MedDRA | Systematic Assessment |
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| Coronary artery occlusion | Cardiac disorders | MedDRA | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
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| Dementia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
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| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Benign colonic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Bladder cancer stage 0 with cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Peripheral ischaemia | Vascular disorders | MedDRA | Systematic Assessment |
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| Peripheral vascular disorder | Vascular disorders | MedDRA | Systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
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| Infarction | Vascular disorders | MedDRA | Systematic Assessment |
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| Appendicitis perforated | Infections and infestations | MedDRA | Systematic Assessment |
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| Celulitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
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| Urospepsis | Infections and infestations | MedDRA | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Bipoplar disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Cardiac pacemaker replacement | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Libido decreased | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068538 | Dutasteride |
| ID | Term |
|---|---|
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| African American |
|
| Asian |
|
| American Indian or Alaskan Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| White and American Indian/Alaskan Native |
|
Statistical data are for Overall (Years 0-3) |
| Relative Risk Estimate |
| 0.61 |
| 95 |
| 0.43 |
| 0.88 |
| No |
| Superiority or Other |
|
|
| Participants |
|
|
|
|
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|
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|
|
|
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| Participants |
|
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| Units | Counts |
|---|
| Participants |
|
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| Participants |
|
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| Participants |
|
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| Participants |
|
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