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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03767244
Registration number
NCT03767244
Ethics application status
Date submitted
5/12/2018
Date registered
6/12/2018
Titles & IDs
Public title
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
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Scientific title
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
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Secondary ID [1]
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56021927PCR3011
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Secondary ID [2]
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CR108535
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Universal Trial Number (UTN)
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Trial acronym
PROTEUS
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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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0
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Condition category
Condition code
Cancer
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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 - Apalutamide
Treatment: Drugs - Androgen Deprivation Therapy (ADT)
Treatment: Drugs - Placebo
Experimental: Apalutamide + ADT - Participants will receive androgen deprivation therapy (ADT) plus oral administration of apalutamide 240 milligram (mg) (4 tablets of 60 mg each) daily in each cycle (each cycle of 28 days). Participants will receive six cycles of treatment, followed by radical prostatectomy (RP) with pelvic lymph node dissection (pLND), followed by an additional six cycles of treatment.
Experimental: Placebo + ADT - Participants will receive ADT with oral administration of matching placebo treatment daily in each cycle (each cycle of 28 days). Participants will receive six cycles of placebo treatment, followed by RP with pLND, followed by an additional six cycles of placebo treatment.
Treatment: Drugs: Apalutamide
Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily.
Treatment: Drugs: Androgen Deprivation Therapy (ADT)
Participants will receive a stable regimen of ADT - gonadotropin-releasing hormone analog (agonist or antagonist) (GnRHa). ADT is a kind of hormone therapy for prostate cancer. GnRHa will be administrated to achieve and maintain sub-castrate concentrations of testosterone (50 nanogram per deciliter \[ng/dL\]).
Treatment: Drugs: Placebo
Participants will receive matching placebo oral tablets 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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Percentage of Participants with Pathologic complete response (pCR)
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Assessment method [1]
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pCR is assessed by a pathology blinded independent central radiology review (BICR) as defined in the pathology charter.
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Timepoint [1]
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Approximately 4 years
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Primary outcome [2]
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Metastasis-Free Survival (MFS)
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Assessment method [2]
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MFS is defined as the time from randomization to the date of the first occurrence of radiographic distant metastasis evaluated by radiology BICR, incidental pathologic finding of distant metastasis, or death from any cause, whichever occurs first.
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Timepoint [2]
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Up to 7 years and 5 months
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Secondary outcome [1]
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Prostate Specific Antigen (PSA)-Free Survival
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Assessment method [1]
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PSA-free survival with testosterone recovery defined as the time from randomization to the first detectable serum PSA level with recovered testosterone levels after undetectable PSA post-radical prostatectomy with pelvic lymph node dissection or death, whichever occurs first.
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Timepoint [1]
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Approximately 4 years
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Secondary outcome [2]
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Event Free Survival (EFS)
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Assessment method [2]
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EFS defined as time from randomization to any of the following events: biochemical failure (BCF); or local or regional recurrence by BICR or histopathological assessment; or distant metastasis by BICR or histopathological assessment; or death.
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Timepoint [2]
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Up to 7 years and 5 months
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Secondary outcome [3]
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Time to Subsequent First Treatments (TTST-1)
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Assessment method [3]
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TTST-1 is defined as the time from randomization to the date of first subsequent therapy.
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Timepoint [3]
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Up to 7 years and 5 months
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Secondary outcome [4]
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Time to Distant Metastasis (TTDM)
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Assessment method [4]
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TTDM is defined as the time from the date of enrollment until the first date of distant metastasis.
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Timepoint [4]
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Up to 7 years and 5 months
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Secondary outcome [5]
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MFS Based on Conventional Imaging
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Assessment method [5]
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MFS based on conventional imaging, defined as the time from randomization to the date of the first occurrence of radiographic distant metastasis on CT/MRI and bone scan by radiology BICR, pathologic finding of distant metastasis, or death from any cause, whichever occurs first.
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Timepoint [5]
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Up to 7 years and 5 months
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Secondary outcome [6]
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Number of Participants with No Evidence of Disease (NED) at 4 Years
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Assessment method [6]
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Number of participants with NED at 4 years will be reported. NED at 4 years is defined as: (a) alive, (b) Undetectable prostate-specific antigen (PSA), (c) No distant metastasis, (d) No local or regional recurrence, (e) No subsequent therapy for prostate cancer, (f) Testosterone recovery to physiological testosterone levels, defined as 200 nanograms per deciliter (ng/dL).
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Timepoint [6]
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Up to 4 years
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Secondary outcome [7]
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Number of Participants with Vital Signs Abnormalities as a Measure of Safety and Tolerability
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Assessment method [7]
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Number of participants with vital signs (including body temperature, heart rate, respiratory rate, and blood pressure) abnormalities will be reported.
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Timepoint [7]
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Up to 30 days after last dose of study drug (Approximately 8 years)
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Secondary outcome [8]
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Number of Participants with Physical Examinations Abnormalities as a Measure of Safety and Tolerability
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Assessment method [8]
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Number of participants with physical examinations (including general appearance of the participant, height, weight, and examination of the skin, ears, nose, throat, lungs, heart, abdomen, extremities, musculoskeletal system, lymphatic system, and nervous system) abnormalities will be reported.
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Timepoint [8]
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Up to 30 days after last dose of study drug (Approximately 8 years)
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Secondary outcome [9]
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Number of Participants with Laboratory Abnormalities as a Measure of Safety and Tolerability
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Assessment method [9]
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Blood samples for serum chemistry and hematology will be collected at predefined time points for clinical laboratory testing.
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Timepoint [9]
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Up to 30 days after last dose of study drug (Approximately 8 years)
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Secondary outcome [10]
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Number of Participants with Treatment Compliance Rate
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Assessment method [10]
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Number of participants who are complaint with study treatment will be assessed.
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Timepoint [10]
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Up to 30 days after last dose of study drug (Approximately 8 years)
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Eligibility
Key inclusion criteria
* Histologically confirmed adenocarcinoma of the prostate
* High-risk disease defined by a total Gleason Sum Score greater than equal to (>=) 4+3 (=Grade Groups [GG] 3 5) and >=1 of the following 4 criteria: a) Any combination of Gleason Score 4+3 (= 3) and Gleason Score 8 (4+4 or 5+3) in >= 6 systematic cores (with >=1 core Gleason Score 8 [4+4 or 5+3] included); b) Any combination of Gleason Score 4+3 (=GG 3) and Gleason Score 8 (4+4 or 5+3) in >=3 systematic cores and Prostate-specific antigen (PSA) >=20 ng/mL (with >= 1 core Gleason Score 8 [4+4 or 5+3] included); c) Gleason Score >=9 (=GG 5) in at least 1 systematic or targeted core; d) At least 2 systematic or targeted cores with continuous Gleason Score >=8 (=GG 4), each with > 80 percent (%) involvement
* Candidate for radical prostatectomy with pelvic lymph node dissection as per the investigator
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
* Contraceptive use by male participants (and female partners of male participants enrolled in the study who are of childbearing potential or are pregnant) should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
* Able to receive androgen deprivation therapy (ADT) for at least 13 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
* Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Participants are considered eligible only if the central radiological review confirms clinical stage M0
* (a) Prior treatment with androgen receptor antagonists; (b) Treatment with gonadotropin-releasing hormone analog (GnRHa) prior to informed consent form (ICF) signature
* History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer
* Use of any investigational agent less than or equals to (<=)4 weeks prior to randomization or any therapeutic procedure for prostate cancer at any time
* Major surgery <=4 weeks prior to randomization
* Any of the following within 12 months prior to first dose of study drug: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (example, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary
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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 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
11/06/2019
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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
19/07/2029
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Actual
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Sample size
Target
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Accrual to date
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Final
2517
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Epworth Eastern Hospital - Box Hill
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St Vincent s Hospital Sydney - Darlinghurst
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Austin Health - Heidelberg
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Australian Urology Associates Pty Ltd - Malvern
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Royal Melbourne Hospital - Parkville
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Northern Cancer Institute - St Leonards
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Recruitment hospital [7]
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Australian Clinical Trials - SAN Clinic - Wahroonga
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Recruitment hospital [8]
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Westmead Hospital - Westmead
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Recruitment hospital [9]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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3128q - Box Hill
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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3084 - Heidelberg
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3144 - Malvern
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3052 - Parkville
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Recruitment postcode(s) [6]
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2065 - St Leonards
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Recruitment postcode(s) [7]
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2076 - Wahroonga
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Recruitment postcode(s) [8]
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2145 - Westmead
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Recruitment postcode(s) [9]
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4102 - Woolloongabba
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Recruitment outside Australia
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California
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Colorado
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Kyoto
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Osaka Sayama shi
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Sakura
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Tokyo
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Ube
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Yokohama
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Barnaul
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Russian Federation
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Tyumen
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Vologda
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Valencia
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Bristol
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Cardiff
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Dundee
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United Kingdom
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London
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Preston
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Sutton
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT.
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Trial website
https://clinicaltrials.gov/study/NCT03767244
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Trial related presentations / publications
Ravi P, Kwak L, Xie W, Kelleher K, Acosta AM, McKay RR, Kibel AS, Taplin ME. Neoadjuvant Novel Hormonal Therapy Followed by Prostatectomy versus Up-Front Prostatectomy for High-Risk Prostate Cancer: A Comparative Analysis. J Urol. 2022 Oct;208(4):838-845. doi: 10.1097/JU.0000000000002803. Epub 2022 Sep 9.
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Public notes
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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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?
The data sharing policy of the Janssen Pharmaceutical companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.janssen.com/clinical-trials/transparency
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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/NCT03767244