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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
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
Secondary ID [1] 0 0
56021927PCR3011
Secondary ID [2] 0 0
CR108535
Universal Trial Number (UTN)
Trial acronym
PROTEUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Pathologic complete response (pCR)
Timepoint [1] 0 0
Approximately 4 years
Primary outcome [2] 0 0
Metastasis-Free Survival (MFS)
Timepoint [2] 0 0
Up to 7 years and 5 months
Secondary outcome [1] 0 0
Prostate Specific Antigen (PSA)-Free Survival
Timepoint [1] 0 0
Approximately 4 years
Secondary outcome [2] 0 0
Event Free Survival (EFS)
Timepoint [2] 0 0
Up to 7 years and 5 months
Secondary outcome [3] 0 0
Time to Subsequent First Treatments (TTST-1)
Timepoint [3] 0 0
Up to 7 years and 5 months
Secondary outcome [4] 0 0
Time to Distant Metastasis (TTDM)
Timepoint [4] 0 0
Up to 7 years and 5 months
Secondary outcome [5] 0 0
MFS Based on Conventional Imaging
Timepoint [5] 0 0
Up to 7 years and 5 months
Secondary outcome [6] 0 0
Number of Participants with No Evidence of Disease (NED) at 4 Years
Timepoint [6] 0 0
Up to 4 years
Secondary outcome [7] 0 0
Number of Participants with Vital Signs Abnormalities as a Measure of Safety and Tolerability
Timepoint [7] 0 0
Up to 30 days after last dose of study drug (Approximately 8 years)
Secondary outcome [8] 0 0
Number of Participants with Physical Examinations Abnormalities as a Measure of Safety and Tolerability
Timepoint [8] 0 0
Up to 30 days after last dose of study drug (Approximately 8 years)
Secondary outcome [9] 0 0
Number of Participants with Laboratory Abnormalities as a Measure of Safety and Tolerability
Timepoint [9] 0 0
Up to 30 days after last dose of study drug (Approximately 8 years)
Secondary outcome [10] 0 0
Number of Participants with Treatment Compliance Rate
Timepoint [10] 0 0
Up to 30 days after last dose of study drug (Approximately 8 years)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/07/2029
Actual
Sample size
Target
Accrual to date
Final
2517
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Epworth Eastern Hospital - Box Hill
Recruitment hospital [2] 0 0
St Vincent s Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Austin Health - Heidelberg
Recruitment hospital [4] 0 0
Australian Urology Associates Pty Ltd - Malvern
Recruitment hospital [5] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [6] 0 0
Northern Cancer Institute - St Leonards
Recruitment hospital [7] 0 0
Australian Clinical Trials - SAN Clinic - Wahroonga
Recruitment hospital [8] 0 0
Westmead Hospital - Westmead
Recruitment hospital [9] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
3128q - Box Hill
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
2065 - St Leonards
Recruitment postcode(s) [7] 0 0
2076 - Wahroonga
Recruitment postcode(s) [8] 0 0
2145 - Westmead
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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United States of America
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California
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Colorado
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Michigan
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Manacor
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Santander
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Sevilla
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Valencia
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Taiwan
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Kaohsiung
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Dundee
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London
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Preston
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Sutton
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Wakefield
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


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