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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01995513
Registration number
NCT01995513
Ethics application status
Date submitted
18/11/2013
Date registered
26/11/2013
Titles & IDs
Public title
Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients
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Scientific title
A PHASE 4, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF CONTINUED ENZALUTAMIDE TREATMENT BEYOND PROGRESSION IN PATIENTS WITH CHEMOTHERAPY-NAÏVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
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Secondary ID [1]
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0
2013-000722-54
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Secondary ID [2]
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MDV3100-10
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Universal Trial Number (UTN)
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Trial acronym
PLATO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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0
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Condition category
Condition code
Cancer
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0
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0
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Enzalutamide
Treatment: Drugs - Abiraterone
Treatment: Drugs - Placebo for Enzalutamide
Treatment: Drugs - Prednisone
Experimental: Enzalutamide & Abiraterone/prednisone - Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with abiraterone (1000 mg) administered as four 250-mg tablets by mouth once daily and prednisone (10 mg) administered as one 5-mg tablet by mouth twice daily
Active comparator: Enzalutamide placebo & Abiraterone/prednisone - Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with abiraterone (1000 mg) administered as four 250-mg tablets by mouth once daily and prednisone (10 mg) administered as one 5-mg tablet by mouth twice daily.
Treatment: Drugs: Enzalutamide
160 mg by mouth once daily
Treatment: Drugs: Abiraterone
1000 mg by mouth once daily
Treatment: Drugs: Placebo for Enzalutamide
Sugar pill manufactured to mimic Enzalutamide 40 mg capsule
Treatment: Drugs: Prednisone
5 mg by mouth twice daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS)
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Assessment method [1]
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PFS = time from randomization to first documentation of radiographic progression (RP),unequivocal clinical progression or death due to any cause (death within 112 days of treatment discontinuation without objective evidence of RP),whichever occurred first as per investigator. Unequivocal disease progression was pain requiring chronic administration of analgesics, decline of prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to 3 or higher or initiation of new anticancer therapy/radiation therapy or surgical intervention due to tumor progression. ECOG score range= 0(no severity) to 5(maximum severity).RP for bone disease was evaluated by appearance of 2 or more new bone lesions as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2) or for soft tissue disease according to Response Evaluation Criteria in Solid Tumor version 1.1. Participants with no PFS event at analysis date were censored at last tumor assessment date prior to data cutoff date.
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Timepoint [1]
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From randomization until disease progression, last tumor assessment without disease progression or death due to any cause, whichever occurred first (maximum up to 20.3 months)
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Secondary outcome [1]
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Time to Prostate Specific Antigen (PSA) Progression
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Assessment method [1]
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Time from date of randomization to the date of first confirmed PSA progression as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2). For participant's whose PSA decreased at Week 13 after randomization, progression was defined as 25 percent (%) PSA increase relative to nadir or absolute increase of \>=2 nanogram/milliliter (ng/mL) above nadir. Progression was confirmed if another assessment measured at least 3 weeks later met the criterion as well. For participant's whose PSA did not decrease at Week 13 after randomization, progression was defined as 25% PSA increase relative to baseline assessed 12 weeks after baseline. Participants who were not known to have had a PFS event at the analysis date were censored at last PSA assessment date prior to data cutoff date.
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Timepoint [1]
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From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)
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Secondary outcome [2]
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Prostate Specific Antigen (PSA) Response Rate
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Assessment method [2]
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PSA response rate was defined as percentage of participants with \>=30% and \>=50% decrease in PSA from baseline at randomization to the maximal PSA response with a threshold of 30% and 50% respectively. PSA response was confirmed if another assessment measured at least 3 weeks later met the criterion as well.
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Timepoint [2]
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From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)
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Secondary outcome [3]
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Objective Response Rate (ORR)
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Assessment method [3]
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Objective response rate as assessed by the investigator according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1) was defined as 1) Percentage of participants with confirmed best overall complete response (CR) and partial response (PR); 2) Percentage of participants with CR, PR and stable disease (SD) for target lesions or non-progressive disease for non-target lesions. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to \<10 millimeter (mm) in short axis. No new lesions and disappearance of all non-target lesions. PR: \>= 30% decrease in sum of diameters of target lesions, compared to the sum at baseline. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.
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Timepoint [3]
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From randomization until CR or PR, whichever occurred first (maximum up to 21.3 months)
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Secondary outcome [4]
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Rate of Pain Progression
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Assessment method [4]
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Rate of pain progression was defined as percentage of participants with an increase of \>=30% from baseline in the mean Brief Pain Inventory-Short Form (BPI-SF) pain intensity item scores of 4 items assessing average, worst, least, and intermediate pain severity. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf score range for each item was from 0=no pain to 10=worst possible pain. Total score was reported as average of individual questions ranges from 0 to 10, where lower scores indicated less pain or less pain interference.
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Timepoint [4]
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Month 6
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Secondary outcome [5]
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Time to First Use of New Antineoplastic Therapy for Prostate Cancer
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Assessment method [5]
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It was defined as time from randomization to the date of first use of subsequent antineoplastic therapy for prostate cancer. For participants who had not started subsequent antineoplastic therapy as of data analysis cutoff date, the time to first use of subsequent antineoplastic therapy was censored at the date of last assessment.
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Timepoint [5]
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From randomization until date of first use of any antineoplastic therapy (after last dose date of Period 2, maximum up to 22.3 months
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Secondary outcome [6]
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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
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Assessment method [6]
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The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 where higher scores represent better quality of life.
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Timepoint [6]
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Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
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Secondary outcome [7]
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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
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Assessment method [7]
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The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for social/family well-being domain is from 0 (worst response) to 32 (best response), where higher score indicate better quality of life.
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Timepoint [7]
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Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
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Secondary outcome [8]
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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
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Assessment method [8]
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The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for emotional well-being domain is from 0 (worst response) to 24 (best response), where higher score indicate better quality of life.
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Timepoint [8]
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Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
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Secondary outcome [9]
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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
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Assessment method [9]
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0
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for functional well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life.
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Timepoint [9]
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Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
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Secondary outcome [10]
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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
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Assessment method [10]
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0
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for prostate cancer domain is from 0 (worst response) to 48 (best response), where higher score indicated better quality of life with fewer symptoms.
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Timepoint [10]
0
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Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
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Secondary outcome [11]
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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
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Assessment method [11]
0
0
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for physical well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life.
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Timepoint [11]
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0
Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
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Secondary outcome [12]
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Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
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Assessment method [12]
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Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 with higher scores representing better quality of life. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation.
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Timepoint [12]
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From randomization up to maximum of 18.4 months
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Eligibility
Key inclusion criteria
* Men with metastatic castration-resistant prostate cancer
* Progressive disease on androgen deprivation therapy
* Patients must agree to continue androgen deprivation therapy with a GnRH agonist/antagonist throughout the study or have had a prior bilateral orchiectomy
* ECOG performance score = 1
* Estimated life expectancy of = 12 months
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or enzalutamide for the treatment of prostate cancer
* Prior participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless the treatment was placebo)
* History of brain metastasis, active leptomeningeal disease or seizure
* Severe cardiovascular or hepatic disease
* Pituitary or adrenal dysfunction
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/10/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/08/2022
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Sample size
Target
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Accrual to date
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Final
509
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Border Medical Oncology Research Unit - Albury
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Recruitment hospital [2]
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0
Ramsay Health Care Australia Pty Ltd - Albury
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Recruitment hospital [3]
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0
Regional Imaging Border - Albury
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Recruitment hospital [4]
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0
Terry White Chemist - Albury
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Recruitment hospital [5]
0
0
Concord Cancer Centre, Medical Oncology Department - Concord
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Recruitment hospital [6]
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0
Concord Hospital Clinical Trials Pharmacy - Concord
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Recruitment hospital [7]
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0
Epic Pharmacy Lismore - Lismore
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Recruitment hospital [8]
0
0
Macquarie University Hospital Pharmacy - North Ryde
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Recruitment hospital [9]
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0
Macquarie University - North Ryde
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Recruitment hospital [10]
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0
Epic Pharmacy Port Macquarie base hospital - Port Macquarie
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Recruitment hospital [11]
0
0
Port Macquarie Base Hospital,North Coast Cancer Institute - Port Macquarie
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Recruitment hospital [12]
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0
North Shore Radiology and Nuclear Medicine - St Leonards
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Recruitment hospital [13]
0
0
Royal North Shore Hospital - St Leonards
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Recruitment hospital [14]
0
0
Sydney Adventist Hospital - Sydney
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Recruitment hospital [15]
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0
Northern NSW Local Health District - Tweed Heads
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Recruitment hospital [16]
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0
Queensland Diagnostic Imaging - Tweed Heads
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Recruitment hospital [17]
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0
Sydney Adventist Hospital - Wahroonga
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Recruitment hospital [18]
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0
Regional Imaging - West Albury
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Recruitment hospital [19]
0
0
Westmead Hospital - Westmead
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Recruitment hospital [20]
0
0
Icon Cancer Care Wesley - Auchenflower
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Recruitment hospital [21]
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0
River City Pharmacy - APHS - Auchenflower
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Recruitment hospital [22]
0
0
Icon Cancer Care Chermside - Chermside
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Recruitment hospital [23]
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0
Gold Coast Radiology PTY LTD - Hope Island
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Recruitment hospital [24]
0
0
Icon Cancer Care South Brisbane - South Brisbane
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Recruitment hospital [25]
0
0
Icon Cancer Care - South Brisbane
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Recruitment hospital [26]
0
0
South Coast Radiology - Tugun
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Recruitment hospital [27]
0
0
Adelaide Cancer Centre - Kurralta Park
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Recruitment hospital [28]
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0
Ashford Cancer Centre Research - Kurralta Park
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Recruitment hospital [29]
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0
Cancer Care SA Pty Ltd - Kurralta Park
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Recruitment hospital [30]
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0
Tenpharm Pty Ltd trading as EPIC Pharmacy Tennyson - Kurralta Park
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Recruitment hospital [31]
0
0
Moorabbin Radiology - Bentleigh East
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Recruitment hospital [32]
0
0
Box Hill Hospital - Box Hill
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Recruitment hospital [33]
0
0
Monash Medical Centre - Clayton
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Recruitment hospital [34]
0
0
Cabrini Health - Cabrini Hospital - Malvern
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Recruitment hospital [35]
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0
Border Medical Oncology - Wodonga
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Recruitment postcode(s) [1]
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0
2640 - Albury
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Recruitment postcode(s) [2]
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0
2139 - Concord
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Recruitment postcode(s) [3]
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0
2480 - Lismore
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Recruitment postcode(s) [4]
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0
2109 - North Ryde
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Recruitment postcode(s) [5]
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0
2444 - Port Macquarie
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Recruitment postcode(s) [6]
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0
2065 - St Leonards
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Recruitment postcode(s) [7]
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0
2076 - Sydney
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Recruitment postcode(s) [8]
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0
2485 - Tweed Heads
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Recruitment postcode(s) [9]
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0
2076 - Wahroonga
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Recruitment postcode(s) [10]
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0
2640 - West Albury
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Recruitment postcode(s) [11]
0
0
2145 - Westmead
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Recruitment postcode(s) [12]
0
0
4066 - Auchenflower
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Recruitment postcode(s) [13]
0
0
4032 - Chermside
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Recruitment postcode(s) [14]
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0
4212 - Hope Island
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Recruitment postcode(s) [15]
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0
4101 - South Brisbane
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Recruitment postcode(s) [16]
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0
4224 - Tugun
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Recruitment postcode(s) [17]
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0
5037 - Kurralta Park
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Recruitment postcode(s) [18]
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0
3165 - Bentleigh East
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Recruitment postcode(s) [19]
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0
3128 - Box Hill
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Recruitment postcode(s) [20]
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0
3168 - Clayton
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Recruitment postcode(s) [21]
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0
3144 - Malvern
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Recruitment postcode(s) [22]
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3690 - Wodonga
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
0
0
Massachusetts
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Pennsylvania
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Virginia
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Country [4]
0
0
Belgium
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State/province [4]
0
0
West-vlaanderen
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Country [5]
0
0
Belgium
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State/province [5]
0
0
Bruxelles
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Country [6]
0
0
Belgium
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State/province [6]
0
0
Leuven
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Country [7]
0
0
Denmark
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State/province [7]
0
0
Norrebro
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Country [8]
0
0
Denmark
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State/province [8]
0
0
Arhus N
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Country [9]
0
0
Denmark
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State/province [9]
0
0
Copenhagen
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Country [10]
0
0
Denmark
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State/province [10]
0
0
Frederiksberg
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Country [11]
0
0
Finland
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State/province [11]
0
0
Helsinki
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Country [12]
0
0
Finland
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State/province [12]
0
0
Oulu
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Country [13]
0
0
Finland
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State/province [13]
0
0
Tampere
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Country [14]
0
0
France
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State/province [14]
0
0
Villejuif Cedex
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Country [15]
0
0
Italy
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State/province [15]
0
0
FC
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Country [16]
0
0
Italy
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State/province [16]
0
0
Cremona
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Country [17]
0
0
Italy
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State/province [17]
0
0
Meldola (FC)
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Country [18]
0
0
Italy
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State/province [18]
0
0
Orbassano TO
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Country [19]
0
0
Italy
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State/province [19]
0
0
Roma
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Country [20]
0
0
Slovakia
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State/province [20]
0
0
Banska Bystrica
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Country [21]
0
0
Slovakia
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State/province [21]
0
0
Bratislava
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Country [22]
0
0
Slovakia
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State/province [22]
0
0
Martin
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Country [23]
0
0
Slovakia
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State/province [23]
0
0
Nitra
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Country [24]
0
0
Slovakia
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State/province [24]
0
0
Trnava
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Country [25]
0
0
Spain
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State/province [25]
0
0
Barcelona
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Country [26]
0
0
Spain
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State/province [26]
0
0
Barcelon
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Country [27]
0
0
Spain
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State/province [27]
0
0
Islas Baleares
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Country [28]
0
0
Spain
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State/province [28]
0
0
Madrid
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Country [29]
0
0
Sweden
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State/province [29]
0
0
Goteborg
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Country [30]
0
0
Sweden
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State/province [30]
0
0
Malmo
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Country [31]
0
0
Sweden
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State/province [31]
0
0
Molnlycke
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Country [32]
0
0
Sweden
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State/province [32]
0
0
Orebro
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Country [33]
0
0
United Kingdom
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State/province [33]
0
0
Middlesex
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Country [34]
0
0
United Kingdom
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State/province [34]
0
0
Surrey
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Country [35]
0
0
United Kingdom
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State/province [35]
0
0
Cardiff
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Country [36]
0
0
United Kingdom
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State/province [36]
0
0
London
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Country [37]
0
0
United Kingdom
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State/province [37]
0
0
Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Commercial sector/industry
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Astellas Pharma Inc
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Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
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Ethics approval
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Summary
Brief summary
The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.
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Trial website
https://clinicaltrials.gov/study/NCT01995513
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Trial related presentations / publications
Attard G, Borre M, Gurney H, Loriot Y, Andresen-Daniil C, Kalleda R, Pham T, Taplin ME; PLATO collaborators. Abiraterone Alone or in Combination With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer With Rising Prostate-Specific Antigen During Enzalutamide Treatment. J Clin Oncol. 2018 Sep 1;36(25):2639-2646. doi: 10.1200/JCO.2018.77.9827. Epub 2018 Jul 20.
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01995513