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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02446444
Registration number
NCT02446444
Ethics application status
Date submitted
4/05/2015
Date registered
18/05/2015
Date last updated
13/02/2024
Titles & IDs
Public title
Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer
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Scientific title
Randomised Phase 3 Trial of Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer: ENZARAD
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Secondary ID [1]
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ACTRN12614000126617
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Secondary ID [2]
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ANZUP1303
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Universal Trial Number (UTN)
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Trial acronym
ENZARAD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms
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Condition category
Condition code
Cancer
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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 - Conventional NSAA
Treatment: Drugs - LHRHA
Treatment: Other - External Beam Radiotherapy (78 Gy in 39 fractions or 46 Gy in 23 fractions plus brachytherapy boost)
Experimental: Enzalutamide - Enzalutamide 160 mg daily, by mouth, for 24 months from randomisation. All participants are treated with a LHRHA for 24 months from randomisation and external beam radiation therapy started approximately 16 weeks after randomisation (+/- brachytherapy boost)
Active Comparator: Conventional Non-steroidal Anti-androgen (NSAA) - Conventional Non-steroidal Anti-androgen (NSAA), by mouth, for 6 months from randomisation.
All participants are treated with a LHRHA for 24 months from randomisation and external beam radiation therapy started approximately 16 weeks after randomisation (+/- brachytherapy boost)
Treatment: Drugs: Enzalutamide
Treatment: Drugs: Conventional NSAA
Treatment: Drugs: LHRHA
Treatment: Other: External Beam Radiotherapy (78 Gy in 39 fractions or 46 Gy in 23 fractions plus brachytherapy boost)
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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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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Metastasis-free survival
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Assessment method [1]
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Metastasis free survival (MFS) is defined as the interval from the date of randomisation to the date of first evidence of metastasis or death from any cause, whichever occurs first, or the date of last known follow-up alive and without metastases.
Evidence of metastasis includes findings on whole body bone scan (WBBS) or CT or MRI that are either characteristic of metastatic prostate cancer, and/or confirmed by other test results, e.g. cytology or histopathology, and lesion qualifies as new metastatic disease per RECIST 1.1. Detection of metastasis by other modalities, eg Ga-68 PSMA (Prostate Specific Membrane Antigen) PET, does not constitute an event unless confirmed by WBBS or CT or MR
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Timepoint [1]
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5 years
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Secondary outcome [1]
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Overall survival
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Assessment method [1]
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Overall survival (OS) is defined as the interval from the date of randomisation to date of death from any cause, or the date of last known follow-up alive.
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Timepoint [1]
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5 years
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Secondary outcome [2]
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Prostate cancer-specific survival
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Assessment method [2]
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Prostate cancer-specific survival is defined as the interval from the date of randomisation to the date of death from prostate cancer, or the date of last known follow-up alive.
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Timepoint [2]
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5 years
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Secondary outcome [3]
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PSA (Prostate-Specific Antigen) progression-free survival
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Assessment method [3]
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PSA progression-free survival is defined as the interval from the date of randomisation to the date of first evidence of PSA progression, clinical progression, or death from any cause, whichever occurs first, or the date of last known follow-up without PSA progression and without clinical progression.
PSA progression as defined by the Phoenix criteria: an increase in PSA of more than 2ng/mL above the nadir (lowest) PSA level.
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Timepoint [3]
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5 years
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Secondary outcome [4]
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Clinical progression-free survival
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Assessment method [4]
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Clinical progression-free survival is defined as the interval from the date of randomisation to the date of first clinical evidence of disease progression or death from any cause, whichever occurs first, or the date of last known follow-up alive without clinical progression.
Clinical evidence of disease progression includes evidence of progression or recurrence on imaging, clinical examination, development of symptoms attributable to cancer progression, or initiation of other anticancer treatment for prostate cancer.
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Timepoint [4]
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5 years
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Secondary outcome [5]
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Time to subsequent hormonal therapy
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Assessment method [5]
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Time to subsequent hormone therapy is the interval from randomisation to the first date that androgen deprivation therapy is recommenced for the treatment of recurrent (or progressive) prostate cancer, or the date of last known follow-up without recommencement of androgen deprivation therapy.
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Timepoint [5]
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5 years
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Secondary outcome [6]
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Time to castration-resistant disease (PCWG2 criteria)
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Assessment method [6]
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Castration resistant prostate cancer (CRPC) is defined, per PCWG2, by a rising PSA that is greater than 2ng/mL higher than the most recent nadir with a testosterone < 50 ng/dL (<1.7 nmol/L); the rise has to be at least 25% over the most recent nadir; and, the rise has to be confirmed by a second PSA at least three weeks later. The time to castration-resistant prostate cancer is defined as the interval from randomisation to the date that the PSA first met the criteria defined above (i.e. the date of the first PSA to meet these criteria, not the date of the subsequent confirmatory test), or the date of last known follow-up without CRPC.
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Timepoint [6]
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5 years
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Secondary outcome [7]
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Safety (adverse events - CTCAE v4.03)
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Assessment method [7]
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The NCI Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) will be used to classify and grade the intensity of adverse events occurring until 30 days after the last dose of study treatment.
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Timepoint [7]
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5 years
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Secondary outcome [8]
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Health related quality of life (HRQL)
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Assessment method [8]
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HRQL will be reported by participants using the EORTC core quality of life questionnaire (QLQ C-30) and prostate cancer specific module (PR-25). The EQ-5D-5L will be used to derive utility scores suitable for quality adjusted survival analyses
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Timepoint [8]
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5 years
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Secondary outcome [9]
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Health outcomes relative to costs (incremental cost effectiveness ratio)
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Assessment method [9]
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Information on the following areas of health-care resource usage will be collected: hospitalisations, visits to health professionals, and medications. Quality-adjusted survival (QAS) time will be used to quantify the incremental effectiveness of adding enzalutamide to standard treatment.
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Timepoint [9]
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5 years
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Eligibility
Key inclusion criteria
Men with localised prostate cancer at high risk for recurrence deemed suitable for external
beam radiation therapy.
1. Pathological diagnosis of adenocarcinoma of the prostate, judged to be at high risk
for recurrence based on any of the following (in accordance with the International
Society of Urological Pathology (ISUP) Consensus 2005:
Gleason score 8-10 OR Gleason score of 4+3 AND clinical T2b-4 AND PSA >20ng/mL OR N1
disease (involvement of lymph nodes at or below the bifurcation of the common iliac
arteries) defined radiologically as greater than 10mm on short axis using standard CT
or MRI, or biopsy proven
2. Age =18 years
3. Adequate bone marrow function Haemoglobin (Hb) =100g/L and White Cell Count (WCC) =
4.0 x 109/L and platelets =100 x 109/L
4. Adequate liver function: Alanine transaminase (ALT) < 2 x ULN and bilirubin < 1.5 x
Upper Limit of Normal (ULN), (or if bilirubin is between 1.5 - 2 x ULN, they must have
a normal conjugated bilirubin).
5. Adequate renal function: calculated creatinine clearance > 30 ml/min (Cockcroft-Gault)
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
7. Study treatment both planned and able to start within 7 days of randomisation.
8. Willing and able to comply with all study requirements, including treatment, and
attending required assessments
9. Has completed the baseline HRQOL questionnaires UNLESS is unable to complete because
of literacy or limited vision
10. Signed, written, informed consent
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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
1. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small
cell components
2. Involvement of lymph nodes superior to the common iliac bifurcation, and/or outside
the pelvis (distant lymph nodes). Lymph node involvement is defined by
histopathological confirmation, or by a short axis measurement >10mm on standard
imaging (CT or MRI, but not PET).
3. Any contraindication to external beam radiotherapy
4. History of
- seizure or any condition that may predispose to seizure (e.g., prior cortical
stroke or significant brain trauma).
- loss of consciousness or transient ischemic attack within 12 months of
randomization
- significant cardiovascular disease within the last 3 months: including myocardial
infarction, unstable angina, congestive heart failure (NYHA grade II or greater),
ongoing arrhythmias of Grade > 2 , thromboembolic events (e.g., deep vein
thrombosis, pulmonary embolism). Chronic stable atrial fibrillation on stable
anticoagulant therapy is allowed.
5. Evidence of metastatic disease: minimum imaging required Computed tomography scan (CT)
/ Magnetic Resonance Imaging (MRI) of the abdomen and pelvis, and Whole Body Bone Scan
(WBBS). If equivocal bone scan, follow-up plain films are required to show NO evidence
of cancer if not covered by CT/MRI
6. PSA > 100 ng/mL
7. History of another malignancy within 5 years prior to randomisation except for
non-melanomatous carcinoma of the skin; or, adequately treated, non-muscle-invasive
urothelial carcinoma of the bladder (i.e. Tis, Ta and low grade T1 tumours).
8. Concurrent illness, including severe infection that might jeopardize the ability of
the patient to undergo the procedures outlined in this protocol with reasonable safety
- Human Immunodeficiency Virus (HIV)-infection is not an exclusion criterion if it
is controlled with anti-retroviral drugs that are unaffected by concomitant
enzalutamide.
9. Presence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule,
including alcohol dependence or drug abuse;
10. Patients who are sexually active and not willing/able to use medically acceptable
forms of barrier contraception.
11. Use of hormonal therapy or androgen deprivation therapy, including enzalutamide,
except in the following setting:
- Use of LHRHA (with or without anti-androgens) for less than 30 days prior to
randomisation in the trial.
12. Bilateral orchidectomy or radical prostatectomy
13. Prior brachytherapy or other radiotherapy that would result in an overlap of
radiotherapy fields
14. Participation in other clinical trials of investigational agents for the treatment of
prostate cancer or other diseases.
15. Major surgery within 21 days prior to randomisation
16. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral
absorption or tolerance of enzalutamide, including difficulty swallowing tablets
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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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
1/03/2014
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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
1/12/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
802
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Blacktown Hospital - Blacktown
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Campbelltown Hospital - Campbelltown
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Recruitment hospital [3]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [4]
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Genesis Cancer Care Newcastle - Gateshead
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Recruitment hospital [5]
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Gosford Hospital - Gosford
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St George Hospital - Kogarah
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Liverpool Hospital - Liverpool
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Orange Health Service - Orange
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Recruitment hospital [9]
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Prince of Wales Hospital - Randwick
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [11]
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St Vincent's Hospital - Sydney
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Tamworth Rural Referral Hospital - Tamworth
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Sydney Adventist Hospital - Wahroonga
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Calvary Mater Newcastle - Waratah
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Westmead Hospital - Westmead
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Wollongong Hospital - Wollongong
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Recruitment hospital [17]
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Genesis Cancer Care Queensland - Wesley and Chermside - Auchenflower
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Recruitment hospital [18]
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Townsville Hospital - Douglas
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Recruitment hospital [19]
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Royal Brisbane & Womens Hospital - Herston
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Recruitment hospital [20]
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Nambour General Hospital - Nambour
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Recruitment hospital [21]
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Radiation Oncology Services Mater Centre - South Brisbane
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Recruitment hospital [22]
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ICON - Gold Coast (formerly ROC Gold Coast) - Southport
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Recruitment hospital [23]
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ICON - Toowoomba (formerly ROC Toowoomba) - Toowoomba
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Recruitment hospital [24]
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Genesis Cancer Care Queensland - Tugun and Southport - Tugun
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Princess Alexandra Hospital Brisbane - Woolloongabba
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Recruitment hospital [26]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [27]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [28]
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Ashford Cancer Centre Research (Adelaide Cancer Centre) - Kurralta Park
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Recruitment hospital [29]
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Royal Hobart Hospital - Hobart
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Recruitment hospital [30]
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Peter MacCallum Cancer Centre - Bendigo
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Recruitment hospital [31]
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Peter MacCallum Cancer Centre (Moorabbin Campus) - Bentleigh East
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Recruitment hospital [32]
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Eastern Health (Box Hill Hospital) - Box Hill
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Recruitment hospital [33]
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Genesis Care - Epping (formerly EROC) - Epping
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Recruitment hospital [34]
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Genesis Care - Western (formerly WROC) - Footscray
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Recruitment hospital [35]
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Genesis Care - Frankston (formerly FROC) - Frankston
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Recruitment hospital [36]
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Austin Health - Heidelberg
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Recruitment hospital [37]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [38]
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Epworth HealthCare - Richmond - Richmond
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Recruitment hospital [39]
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Genesis Care - Ringwood (formerly RROC) - Ringwood East
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Recruitment hospital [40]
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Sunshine Hospital - St Albans
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Recruitment hospital [41]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2560 - Campbelltown
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Recruitment postcode(s) [3]
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2050 - Camperdown
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Recruitment postcode(s) [4]
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2290 - Gateshead
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Recruitment postcode(s) [5]
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2250 - Gosford
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Recruitment postcode(s) [6]
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2217 - Kogarah
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Recruitment postcode(s) [7]
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2170 - Liverpool
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Recruitment postcode(s) [8]
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2800 - Orange
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Recruitment postcode(s) [9]
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2131 - Randwick
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Recruitment postcode(s) [10]
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2065 - St Leonards
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Recruitment postcode(s) [11]
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2010 - Sydney
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Recruitment postcode(s) [12]
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2340 - Tamworth
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Recruitment postcode(s) [13]
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2076 - Wahroonga
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Recruitment postcode(s) [14]
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2298 - Waratah
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Recruitment postcode(s) [15]
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2145 - Westmead
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Recruitment postcode(s) [16]
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2500 - Wollongong
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Recruitment postcode(s) [17]
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4066 - Auchenflower
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Recruitment postcode(s) [18]
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4814 - Douglas
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Recruitment postcode(s) [19]
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4006 - Herston
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Recruitment postcode(s) [20]
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4560 - Nambour
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Recruitment postcode(s) [21]
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4101 - South Brisbane
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Recruitment postcode(s) [22]
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4215 - Southport
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Recruitment postcode(s) [23]
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4350 - Toowoomba
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Recruitment postcode(s) [24]
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4224 - Tugun
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Recruitment postcode(s) [25]
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4102 - Woolloongabba
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Recruitment postcode(s) [26]
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5000 - Adelaide
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Recruitment postcode(s) [27]
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5042 - Bedford Park
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Recruitment postcode(s) [28]
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5037 - Kurralta Park
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Recruitment postcode(s) [29]
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7000 - Hobart
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Recruitment postcode(s) [30]
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3550 - Bendigo
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Recruitment postcode(s) [31]
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3165 - Bentleigh East
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Recruitment postcode(s) [32]
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3128 - Box Hill
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Recruitment postcode(s) [33]
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3076 - Epping
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Recruitment postcode(s) [34]
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3011 - Footscray
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Recruitment postcode(s) [35]
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3199 - Frankston
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Recruitment postcode(s) [36]
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3084 - Heidelberg
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Recruitment postcode(s) [37]
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3002 - Melbourne
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Recruitment postcode(s) [38]
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3121 - Richmond
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Recruitment postcode(s) [39]
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3135 - Ringwood East
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Recruitment postcode(s) [40]
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3021 - St Albans
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Recruitment postcode(s) [41]
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6149 - Murdoch
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
0
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Massachusetts
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0
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Austria
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Salzburg
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0
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Belgium
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Kortrijk
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Ireland
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Co Cork
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Ireland
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Co Galway
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0
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Ireland
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Dublin 7
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0
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Ireland
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Dublin
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0
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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State/province [10]
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Palmerston North
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0
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Slovenia
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Ljubljana
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Spain
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Barcelona
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Spain
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Gipuzkoa
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Spain
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Salamanca
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0
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United Kingdom
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Cardiff
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United Kingdom
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Hampshire
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United Kingdom
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Kent
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United Kingdom
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London
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0
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United Kingdom
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State/province [19]
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Scotland
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0
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United Kingdom
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State/province [20]
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Bath
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United Kingdom
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0
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Cambridge
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Country [22]
0
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United Kingdom
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State/province [22]
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Nottingham
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Other collaborator category [1]
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0
Other
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Name [1]
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Australian and New Zealand Urogenital and Prostate Cancer Trials Group
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Address [1]
0
0
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Country [1]
0
0
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Other collaborator category [2]
0
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Other
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Name [2]
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National Health and Medical Research Council, Australia
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Address [2]
0
0
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Country [2]
0
0
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Other collaborator category [3]
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Other
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Name [3]
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Cancer Trials Ireland
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Address [3]
0
0
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Country [3]
0
0
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Other collaborator category [4]
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Other
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Name [4]
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Trans Tasman Radiation Oncology Group
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Address [4]
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0
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0
0
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Other collaborator category [5]
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Other
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Name [5]
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European Organisation for Research and Treatment of Cancer - EORTC
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Address [5]
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Country [5]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine the effectiveness of enzalutamide as part of
adjuvant androgen deprivation therapy (ADT) with a luteinizing hormone releasing hormone
analogue (LHRHA) in men having radiation therapy for localised prostate cancer at high risk
of recurrence.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02446444
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Scott Williams
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Address
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ANZUP and Peter MacCallum Cancer Centre
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02446444
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