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Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00470834
Recruitment Status : Completed
First Posted : May 8, 2007
Results First Posted : November 1, 2013
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Neoplasms, Prostate
Interventions Drug: dutasteride
Drug: placebo
Drug: bicalutamide
Enrollment 127
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bicalutamide 50 mg/Placebo Bicalutamide 50 mg/Dutasteride 3.5 mg
Hide Arm/Group Description Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal). Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Period Title: Treatment Period (18 Months)
Started 65 62
Completed 27 31
Not Completed 38 31
Reason Not Completed
Protocol-defined Stopping Criteria             16             14
Adverse Event             7             6
Withdrawal by Subject             4             5
Physician Decision             4             4
Protocol Violation             3             1
Sponsor Terminated Study             1             1
Lost to Follow-up             1             0
Non-compliance             1             0
Lack of Efficacy             1             0
Period Title: Extension Period (24 Months)
Started 26 [1] 30 [1]
Completed 11 7
Not Completed 15 23
Reason Not Completed
Protocol-defined Stopping Criteria             6             7
Adverse Event             3             4
Withdrawal by Subject             2             5
Physician Decision             4             3
Sponsor Terminated Study             0             1
Lost to Follow-up             0             1
Non-compliance             0             1
Disease Progression             0             1
[1]
One participant who completed the Treatment Period did not participate in the Extension Period.
Arm/Group Title Bicalutamide 50 mg/Placebo Bicalutamide 50 mg/Dutasteride 3.5 mg Total
Hide Arm/Group Description Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal). Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal). Total of all reporting groups
Overall Number of Baseline Participants 65 62 127
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 62 participants 127 participants
77.6  (7.90) 78.9  (5.94) 78.3  (7.02)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 62 participants 127 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
65
 100.0%
62
 100.0%
127
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 62 participants 127 participants
African American/African Heritage 11 10 21
American Indian or Alaska Native 2 1 3
Asian-Japanese Heritage 1 0 1
Asian-South East Asian Heritage 0 1 1
White-White/Caucasian/European Heritage 51 50 101
1.Primary Outcome
Title Time to Disease Progression
Hide Description Time to disease progression (PD) is defined as the interval of time between the date of the start of treatment and the date of PD. PD is defined as prostate specific antigen (PSA) progression from Baseline (PSA value is 25% and at least 2 nanograms per milliliter [ng/mL] above Baseline, confirmed by a second PSA value); PSA progression from nadir, without a 50% decrease from Baseline (PSA value is 25% and at least 2 ng/mL above nadir, confirmed by a second PSA value); PSA progression from nadir, with a 50% or more decrease from Baseline (PSA value is 50% and at least 2 ng/mL above nadir, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or the receipt of post-Baseline rescue medication. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.
Time Frame Interval of time between the date of the start of treatment and the date of disease progression (up to Study Month 42)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all participants randomized to study treatment. Data were not summarized for censored participants (no disease progression).
Arm/Group Title Bicalutamide 50 mg/Placebo Bicalutamide 50 mg/Dutasteride 3.5 mg
Hide Arm/Group Description:
Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Overall Number of Participants Analyzed 41 40
Mean (Standard Deviation)
Unit of Measure: Days
376.9  (333.94) 433.1  (324.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bicalutamide 50 mg/Placebo, Bicalutamide 50 mg/Dutasteride 3.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bicalutamide 50 mg/Placebo, Bicalutamide 50 mg/Dutasteride 3.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.61 to 1.46
Estimation Comments The hazard ratio is based on the Cox proportional hazards model.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Bicalutamide 50 mg/Placebo, Bicalutamide 50 mg/Dutasteride 3.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk Reduction
Estimated Value 5.62
Confidence Interval (2-Sided) 95%
-46.14 to 39.05
Estimation Comments Relative Risk Reduction = 100 * (1 - Relative Risk).
2.Secondary Outcome
Title Time to Treatment Failure
Hide Description Time to treatment failure is defined as the interval of time between the date of the start of treatment and the date of treatment failure. Treatment failure is defined as PSA progression from Baseline (PSA value is 25% and at least 2 ng/mL above Baseline, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or receipt of post-baseline rescue medications. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.
Time Frame Interval of time between the date of the start of treatment and the date of treatment failure (up to Study Month 42)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Data were not summarized for censored participants (no treatment failure).
Arm/Group Title Bicalutamide 50 mg/Placebo Bicalutamide 50 mg/Dutasteride 3.5 mg
Hide Arm/Group Description:
Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Overall Number of Participants Analyzed 31 28
Mean (Standard Deviation)
Unit of Measure: Days
368.4  (323.94) 457.5  (322.01)
3.Secondary Outcome
Title Number of Participants With PSA Response
Hide Description PSA response is defined as a 50% or greater decrease in PSA from Baseline, confirmed by a second PSA measurement. The time of this response was the date of the first PSA measurement that showed a 50% or greater decrease from the Baseline PSA measurement. PSA confirmation was not required if no subsequent PSA values were available.
Time Frame Time from Baseline PSA measurement until the first PSA measurement with a 50% or greater reduction in PSA values (up to Study Month 42)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Bicalutamide 50 mg/Placebo Bicalutamide 50 mg/Dutasteride 3.5 mg
Hide Arm/Group Description:
Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Overall Number of Participants Analyzed 65 62
Measure Type: Number
Unit of Measure: participants
Months 1-18, n=65, 62 37 38
Months 19-42, n=4, 7 0 0
Overall (Months 1-42), n=65, 62 37 38
4.Secondary Outcome
Title Change From Baseline in Total PSA at Months 6, 12, 18, 21, and 42
Hide Description Change from Baseline in total PSA was measured at each scheduled post-baseline visit using a general linear model with effects for treatment and Baseline total PSA. Analysis was done using the last observation carried forward (LOCF) approach, in which missing post-Baseline values were imputed with earlier non-missing values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline and Months 6, 12, 18, 21, and 42
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Bicalutamide 50 mg/Placebo Bicalutamide 50 mg/Dutasteride 3.5 mg
Hide Arm/Group Description:
Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Overall Number of Participants Analyzed 65 62
Median (Full Range)
Unit of Measure: Nanograms per milliliter (ng/mL)
Month 6, n=62, 61
-2.0
(-12.4 to 74.0)
-2.2
(-17.6 to 15.0)
Month 12, n=62, 61
-1.7
(-12.5 to 74.0)
-2.1
(-17.7 to 33.6)
Month 18, n=62, 61
-1.2
(-12.7 to 74.0)
-1.7
(-17.9 to 33.6)
Month 21, n=26, 30
-2.1
(-12.7 to 2.4)
-1.8
(-17.9 to 7.0)
Month 42, n=26, 30
-0.1
(-12.7 to 23.6)
0.6
(-18.0 to 13.0)
5.Secondary Outcome
Title Number of Participants With Metastatic Disease
Hide Description Metastatic disease is that evidenced by a radiographic assessment. The time of metastatic disease was the date of radiographic evidence.
Time Frame Interval of time between the date of the start of treatment and the date of radiographic evidence of metastatic disease (up to Study Month 42)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Bicalutamide 50 mg/Placebo Bicalutamide 50 mg/Dutasteride 3.5 mg
Hide Arm/Group Description:
Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Overall Number of Participants Analyzed 65 62
Measure Type: Number
Unit of Measure: participants
Months 1-18, n=65, 62 8 5
Months 19-42, n=26, 30 1 1
Overall (Months 1-42), n=65, 62 9 6
Time Frame Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]).
Adverse Event Reporting Description SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
 
Arm/Group Title Bicalutamide 50 mg/Placebo Bicalutamide 50 mg/Dutasteride 3.5 mg
Hide Arm/Group Description Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal). Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
All-Cause Mortality
Bicalutamide 50 mg/Placebo Bicalutamide 50 mg/Dutasteride 3.5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bicalutamide 50 mg/Placebo Bicalutamide 50 mg/Dutasteride 3.5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   31/65 (47.69%)   30/62 (48.39%) 
Blood and lymphatic system disorders     
Anaemia  1  2/65 (3.08%)  1/62 (1.61%) 
Cardiac disorders     
Myocardial infarction  1  2/65 (3.08%)  2/62 (3.23%) 
Cardiac failure congestive  1  1/65 (1.54%)  2/62 (3.23%) 
Acute myocardial infarction  1  0/65 (0.00%)  1/62 (1.61%) 
Angina pectoris  1  1/65 (1.54%)  0/62 (0.00%) 
Atrial fibrillation  1  0/65 (0.00%)  1/62 (1.61%) 
Cardiac arrest  1  0/65 (0.00%)  1/62 (1.61%) 
Cardio-respiratory arrest  1  1/65 (1.54%)  0/62 (0.00%) 
Coronary artery disease  1  0/65 (0.00%)  1/62 (1.61%) 
Supraventricular tachycardia  1  1/65 (1.54%)  0/62 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  0/65 (0.00%)  1/62 (1.61%) 
Gastrointestinal disorders     
Lower gastrointestinal haemorrhage  1  2/65 (3.08%)  0/62 (0.00%) 
Faecaloma  1  1/65 (1.54%)  1/62 (1.61%) 
Colitis  1  1/65 (1.54%)  0/62 (0.00%) 
Gastrointestinal haemorrhage  1  1/65 (1.54%)  0/62 (0.00%) 
Hiatus hernia  1  1/65 (1.54%)  0/62 (0.00%) 
General disorders     
Non-cardiac chest pain  1  2/65 (3.08%)  0/62 (0.00%) 
Chest pain  1  0/65 (0.00%)  1/62 (1.61%) 
Oedema peripheral  1  0/65 (0.00%)  1/62 (1.61%) 
Hepatobiliary disorders     
Cholecystitis acute  1  1/65 (1.54%)  0/62 (0.00%) 
Infections and infestations     
Pneumonia  1  3/65 (4.62%)  0/62 (0.00%) 
Cellulitis  1  0/65 (0.00%)  2/62 (3.23%) 
Lobar pneumonia  1  1/65 (1.54%)  1/62 (1.61%) 
Urinary tract infection  1  1/65 (1.54%)  1/62 (1.61%) 
Orchitis  1  1/65 (1.54%)  0/62 (0.00%) 
Urosepsis  1  1/65 (1.54%)  0/62 (0.00%) 
Streptococcal bacteraemia  1  1/65 (1.54%)  0/62 (0.00%) 
Sepsis syndrome  1  1/65 (1.54%)  0/62 (0.00%) 
Injury, poisoning and procedural complications     
Hip fracture  1  0/65 (0.00%)  2/62 (3.23%) 
Rib fracture  1  1/65 (1.54%)  1/62 (1.61%) 
Femoral neck fracture  1  1/65 (1.54%)  0/62 (0.00%) 
Heat stroke  1  1/65 (1.54%)  0/62 (0.00%) 
Humerus fracture  1  0/65 (0.00%)  1/62 (1.61%) 
Subdural haematoma  1  1/65 (1.54%)  0/62 (0.00%) 
Postoperative ileus  1  1/65 (1.54%)  0/62 (0.00%) 
Investigations     
Blood pressure increased  1  0/65 (0.00%)  1/62 (1.61%) 
Metabolism and nutrition disorders     
Dehydration  1  0/65 (0.00%)  1/62 (1.61%) 
Diabetes mellitus inadequate control  1  0/65 (0.00%)  1/62 (1.61%) 
Failure to thrive  1  0/65 (0.00%)  1/62 (1.61%) 
Hypoglycaemia  1  0/65 (0.00%)  1/62 (1.61%) 
Decreased appetite  1  1/65 (1.54%)  0/62 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  1/65 (1.54%)  0/62 (0.00%) 
Pain in extremity  1  1/65 (1.54%)  0/62 (0.00%) 
Rhabdomyolysis  1  0/65 (0.00%)  1/62 (1.61%) 
Spinal column stenosis  1  0/65 (0.00%)  1/62 (1.61%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer  1  0/65 (0.00%)  2/62 (3.23%) 
Rectal cancer  1  0/65 (0.00%)  1/62 (1.61%) 
Refractory anaemia with an excess of blasts  1  0/65 (0.00%)  1/62 (1.61%) 
Lung neoplasm malignant  1  0/65 (0.00%)  1/62 (1.61%) 
Malignant lymphoid neoplasm  1  0/65 (0.00%)  1/62 (1.61%) 
Nervous system disorders     
Cerebrovascular accident  1  2/65 (3.08%)  2/62 (3.23%) 
Transient ischaemic attack  1  0/65 (0.00%)  2/62 (3.23%) 
Dizziness  1  1/65 (1.54%)  0/62 (0.00%) 
Headache  1  1/65 (1.54%)  0/62 (0.00%) 
Loss of consciousness  1  1/65 (1.54%)  0/62 (0.00%) 
Presyncope  1  1/65 (1.54%)  0/62 (0.00%) 
Syncope  1  1/65 (1.54%)  0/62 (0.00%) 
Parkinson's disease  1  1/65 (1.54%)  0/62 (0.00%) 
Psychiatric disorders     
Mental status changes  1  2/65 (3.08%)  1/62 (1.61%) 
Completed suicide  1  0/65 (0.00%)  1/62 (1.61%) 
Confusional state  1  1/65 (1.54%)  0/62 (0.00%) 
Renal and urinary disorders     
Renal failure  1  2/65 (3.08%)  0/62 (0.00%) 
Urinary retention  1  2/65 (3.08%)  0/62 (0.00%) 
Haematuria  1  0/65 (0.00%)  1/62 (1.61%) 
Renal failure acute  1  0/65 (0.00%)  1/62 (1.61%) 
Renal failure chronic  1  1/65 (1.54%)  0/62 (0.00%) 
Postrenal failure  1  1/65 (1.54%)  0/62 (0.00%) 
Urethral stenosis  1  1/65 (1.54%)  0/62 (0.00%) 
Bladder outlet obstruction  1  1/65 (1.54%)  0/62 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  0/65 (0.00%)  1/62 (1.61%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  2/65 (3.08%)  1/62 (1.61%) 
Chronic obstructive pulmonary disease  1  2/65 (3.08%)  1/62 (1.61%) 
Atelectasis  1  1/65 (1.54%)  1/62 (1.61%) 
Hypoxia  1  1/65 (1.54%)  1/62 (1.61%) 
Pleural effusion  1  1/65 (1.54%)  1/62 (1.61%) 
Asthma  1  1/65 (1.54%)  0/62 (0.00%) 
Pneumonia aspiration  1  1/65 (1.54%)  0/62 (0.00%) 
Respiratory failure  1  0/65 (0.00%)  1/62 (1.61%) 
Vascular disorders     
Aortic aneurysm  1  0/65 (0.00%)  1/62 (1.61%) 
Lymphoedema  1  0/65 (0.00%)  1/62 (1.61%) 
Peripheral vascular disorder  1  0/65 (0.00%)  1/62 (1.61%) 
Deep vein thrombosis  1  0/65 (0.00%)  1/62 (1.61%) 
Peripheral artery aneurysm  1  0/65 (0.00%)  1/62 (1.61%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bicalutamide 50 mg/Placebo Bicalutamide 50 mg/Dutasteride 3.5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   48/65 (73.85%)   51/62 (82.26%) 
Blood and lymphatic system disorders     
Anaemia  1  7/65 (10.77%)  6/62 (9.68%) 
Gastrointestinal disorders     
Constipation  1  8/65 (12.31%)  6/62 (9.68%) 
Diarrhoea  1  8/65 (12.31%)  5/62 (8.06%) 
Nausea  1  4/65 (6.15%)  4/62 (6.45%) 
Vomiting  1  4/65 (6.15%)  2/62 (3.23%) 
General disorders     
Oedema peripheral  1  8/65 (12.31%)  9/62 (14.52%) 
Fatigue  1  7/65 (10.77%)  5/62 (8.06%) 
Asthenia  1  6/65 (9.23%)  5/62 (8.06%) 
Infections and infestations     
Urinary tract infection  1  8/65 (12.31%)  10/62 (16.13%) 
Nasopharyngitis  1  7/65 (10.77%)  6/62 (9.68%) 
Upper respiratory tract infection  1  6/65 (9.23%)  3/62 (4.84%) 
Sinusitis  1  4/65 (6.15%)  3/62 (4.84%) 
Ear infection  1  4/65 (6.15%)  1/62 (1.61%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  6/65 (9.23%)  5/62 (8.06%) 
Back pain  1  2/65 (3.08%)  8/62 (12.90%) 
Pain in extremity  1  1/65 (1.54%)  5/62 (8.06%) 
Nervous system disorders     
Dizziness  1  9/65 (13.85%)  7/62 (11.29%) 
Headache  1  6/65 (9.23%)  2/62 (3.23%) 
Renal and urinary disorders     
Urinary retention  1  5/65 (7.69%)  2/62 (3.23%) 
Haematuria  1  6/65 (9.23%)  0/62 (0.00%) 
Pollakiuria  1  2/65 (3.08%)  4/62 (6.45%) 
Urinary incontinence  1  4/65 (6.15%)  2/62 (3.23%) 
Nocturia  1  5/65 (7.69%)  0/62 (0.00%) 
Reproductive system and breast disorders     
Breast tenderness  1  4/65 (6.15%)  2/62 (3.23%) 
Nipple pain  1  1/65 (1.54%)  4/62 (6.45%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/65 (4.62%)  4/62 (6.45%) 
Vascular disorders     
Hot flush  1  9/65 (13.85%)  3/62 (4.84%) 
Hypertension  1  6/65 (9.23%)  2/62 (3.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00470834     History of Changes
Other Study ID Numbers: AVO108943
First Submitted: May 7, 2007
First Posted: May 8, 2007
Results First Submitted: August 29, 2013
Results First Posted: November 1, 2013
Last Update Posted: February 27, 2017