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History of Changes for Study: NCT03767244
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Latest version (submitted August 30, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 5, 2018 None (earliest Version on record)
2 December 13, 2018 Contacts/Locations and Study Status
3 January 14, 2019 Contacts/Locations, Study Status and Oversight
4 February 7, 2019 Contacts/Locations and Study Status
5 March 7, 2019 Study Status and Contacts/Locations
6 April 30, 2019 Arms and Interventions, Contacts/Locations, Study Status, Outcome Measures, Study Description, Eligibility and Study Identification
7 May 28, 2019 Study Status and Contacts/Locations
8 June 27, 2019 Recruitment Status, Study Status and Contacts/Locations
9 July 25, 2019 Contacts/Locations and Study Status
10 August 21, 2019 Contacts/Locations and Study Status
11 September 18, 2019 Contacts/Locations and Study Status
12 November 4, 2019 Contacts/Locations, Study Status and Arms and Interventions
13 November 14, 2019 Contacts/Locations and Study Status
14 December 11, 2019 Study Status and Contacts/Locations
15 January 9, 2020 Contacts/Locations and Study Status
16 February 5, 2020 Contacts/Locations and Study Status
17 March 3, 2020 Outcome Measures, Arms and Interventions, Study Status, Contacts/Locations, Eligibility and Study Description
18 April 2, 2020 Contacts/Locations and Study Status
19 May 28, 2020 Contacts/Locations and Study Status
20 June 25, 2020 Contacts/Locations and Study Status
21 July 23, 2020 Study Status and Contacts/Locations
22 August 20, 2020 Study Status and Contacts/Locations
23 September 17, 2020 Contacts/Locations and Study Status
24 October 15, 2020 Contacts/Locations and Study Status
25 November 12, 2020 Contacts/Locations and Study Status
26 December 14, 2020 Study Description, Study Status, Eligibility, Outcome Measures and Arms and Interventions
27 January 7, 2021 Contacts/Locations and Study Status
28 February 4, 2021 Study Status and Contacts/Locations
29 March 4, 2021 Contacts/Locations and Study Status
30 April 19, 2021 Contacts/Locations, Arms and Interventions, Study Description, Study Status, Eligibility and Outcome Measures
31 April 29, 2021 Contacts/Locations and Study Status
32 May 27, 2021 Study Status and Contacts/Locations
33 July 1, 2021 Study Status, Contacts/Locations, Outcome Measures and Study Design
34 July 22, 2021 Contacts/Locations and Study Status
35 August 19, 2021 Study Status and Contacts/Locations
36 September 16, 2021 Contacts/Locations and Study Status
37 October 14, 2021 Contacts/Locations and Study Status
38 November 4, 2021 Contacts/Locations and Study Status
39 December 7, 2021 Study Status, Contacts/Locations, Outcome Measures, Study Design and Study Description
40 December 30, 2021 Contacts/Locations and Study Status
41 January 27, 2022 Study Status and Contacts/Locations
42 February 24, 2022 Study Status
43 March 24, 2022 Study Status and Contacts/Locations
44 May 13, 2022 Contacts/Locations, Outcome Measures, Study Status, Eligibility and Study Description
45 June 16, 2022 Contacts/Locations and Study Status
46 July 5, 2022 Study Status and Contacts/Locations
47 August 2, 2022 Contacts/Locations and Study Status
48 August 30, 2022 Contacts/Locations and Study Status
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Study NCT03767244
Submitted Date:  December 5, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: CR108535
Brief Title: A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Official 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 IDs: 56021927PCR3011 [Janssen Research & Development, LLC]
2018-001746-34 [EudraCT Number]
Open or close this module Study Status
Record Verification: December 2018
Overall Status: Not yet recruiting
Study Start: February 15, 2019
Primary Completion: April 22, 2024 [Anticipated]
Study Completion: April 15, 2027 [Anticipated]
First Submitted: December 5, 2018
First Submitted that
Met QC Criteria:
December 5, 2018
First Posted: December 6, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
December 5, 2018
Last Update Posted: December 6, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Janssen Research & Development, LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to determine if treatment with androgen deprivation therapy (ADT) plus apalutamide (with or without abiraterone acetate with prednisone [AAP]) before and after radical prostatectomy 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 ADT plus placebo.
Detailed Description:
Open or close this module Conditions
Conditions: Prostatic Neoplasms
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 1500 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: ADT + Apalutamide (With or Without AAP)
Participants will receive androgen deprivation therapy (ADT) plus oral administration of apalutamide 240 milligram (mg) (4 tablets of 60 mg each) or ADT plus fixed-dose combination (FDC) tablets (250 mg of abiraterone acetate/60 mg apalutamide) with prednisone 10 mg (2 tablets of 5 mg each) daily in each cycle (each cycle of 28 days). Participants will receive six cycles of treatment, followed by radical prostatectomy, followed by an additional six cycles of treatment.
Drug: Apalutamide
Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily.
Other Names:
  • JNJ-56021927
Drug: 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 subcastrate concentrations of testosterone (50 nanogram per deciliter [ng/dL]).
Drug: Prednisone
Participants will receive prednisone 10 mg (2 tablets of 5 mg each) orally daily.
Drug: Fixed-Dose Combination
Participants will receive abiraterone acetate 1,000 mg/apalutamide 240 mg (4 tablets of 250 mg/60 mg tablets).
Experimental: ADT + Placebo
Participants will receive ADT with oral administration of matching placebo treatment.
Drug: 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 subcastrate concentrations of testosterone (50 nanogram per deciliter [ng/dL]).
Drug: Placebo
Participants will receive matching placebo oral tablets in fasted condition and matched capsules orally in fed condition daily.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percentage of Participants with Pathologic complete response (pCR)
[ Time Frame: Approximately 3.5 years ]

pCR is defined as no residual tumor detected in the prostatectomy specimen both by hematoxylin and eosin (H&E) staining and ancillary immunohistochemistry (IHC) as needed, as assessed by a pathology blinded independent central radiology review (BICR).
2. Metastasis-Free Survival (MFS)
[ Time Frame: Approximately 5 years ]

MFS is defined as the time from randomization to the date of the first occurrence of radiographic bone or soft tissue distant metastasis by radiology BICR, incidental pathologic finding of distant metastasis, or death from any cause, whichever occurs first.
Secondary Outcome Measures:
1. Prostate Specific Antigen (PSA)-Free Survival
[ Time Frame: Approximately 8 years ]

PSA-free survival with testosterone recovery (within normal limits) defined as the time from randomization to the first detectable serum PSA level with recovered testosterone levels after undetectable PSA post-radical prostatectomy with lymph node dissection (RPLND) or death, whichever occurs first.
2. Progression-Free Survival (PFS)
[ Time Frame: Approximately 8 years ]

PFS is defined as the time from randomization to first documentation of BICR confirmed radiographic progressive disease or death due to any cause (whichever occurs first) plus 1 day. Progressive disease will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. As per RECIST v1.1, for participants with at least 1 measurable lesion, disease progression will be defined as at least a 20 percent (%) increase in the sum of diameters of target lesions taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For participants with only non-measurable disease observed on computed tomography (CT) or magnetic resonance imaging (MRI) scans, unequivocal progression or the appearance of one or more new lesions will be considered progression. For new bone lesions detected on bone scans, a second imaging modality will be required to confirm progression.
3. Number of Participants with Adverse Events
[ Time Frame: Up to 30 days after last dose of study drug (Approximately 8 years) ]

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
4. Number of Participants with Laboratory Abnormalities as a Measure of Safety and Tolerability
[ Time Frame: Up to 30 days after last dose of study drug (Approximately 8 years) ]

Blood samples for serum chemistry and hematology will be collected at predefined time points for clinical laboratory testing.
5. Number of Participants with Treatment Compliance Rate
[ Time Frame: Up to 30 days after last dose of study drug (Approximately 8 years) ]

Number of participants who are complaint with study treatment will be assessed.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Male
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate
  • Candidate for radical prostatectomy as per the investigator
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Contraceptive (birth control) use by men (or female partners of men enrolled in the study who are of childbearing potential or are pregnant) should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
  • Able to receive androgen deprivation therapy (ADT) for up to 1 year, per the investigator's assessment

Exclusion Criteria:

  • Distant metastasis (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
  • Prior treatment with anti-androgen
  • Prior treatment for prostate cancer
  • Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostat
  • History of any pelvic radiation
Open or close this module Contacts/Locations
Central Contact Person: Study Contact
Telephone: 844-434-4210
Email: JNJ.CT@sylogent.com
Study Officials: Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Locations: United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Michigan Institute of Urology, PC
Troy, Michigan, United States, 48084
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63110
United States, New York
Albany Medical College
Albany, New York, United States, 12208
United States, Virginia
Virginia Urology
Richmond, Virginia, United States, 23235
Argentina
Centro de Urologia (CDU)
Ciudad Automoma Buenos Aires, Argentina, C1120AAT
Centro Urologico Profesor Bengio
Cordoba, Argentina, X5000KPH
Australia
Epworth Eastern Hospital
Box Hill, Australia, 3128q
St. Vincent's Hospital Sydney
Darlinghurst, Australia, 2010
Austin Health
Heidelberg, Australia, 3084
St George Private Hospital
Kogarah, Australia, 2217
Australian Urology Associates Pty Ltd
Malvern, Australia, 3144
Peter MacCallum Cancer Centre
Melbourne, Australia, 3000
Royal Melbourne Hospital
Parkville, Australia, 3050
Prince Of Wales Hospital
Randwick, Australia, 2031
ICON Cancer Care
South Brisbane, Australia, 4101
Northern Cancer Institute
St Leonards, Australia, 2065
Australian Clinical Trials - SAN Clinic
Wahroonga, Australia, 2076
Westmead Hospital
Westmead, Australia, 2145
Princess Alexandra Hospital
Woolloongabba, Australia, 4102
Brazil
Liga Norte Riograndense Contra O Cancer
Natal, Brazil, 59075-740
Canada
CHUQ - CHU de Quebec
Quebec, Canada, G1R 2J6
Vancouver Prostate Centre - Diamond Health Care Centre
Vancouver, Canada, V5Z 1M9
Canada, Alberta
Southern Alberta Institute of Urology / Prostate Cancer Centre
Calgary, Alberta, Canada, T2V 1P9
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Exdeo Clinical Research Inc
Abbotsford, British Columbia, Canada, V2S 3N5
Canada, Nova Scotia
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
McMaster Institute of Urology
Hamilton, Ontario, Canada, L8N 4A6
London Health Sciences Center
London, Ontario, Canada, N6A 5W9
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
University Health Network (UHN) Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
CHUM - Centre hospitalier universitaire de Montreal
Montreal, Quebec, Canada, H2X 0A9
China
Chongqing Cancer hospital
Chongqing, China, 400030
Southwest Hospital
Chongqing, China, 400038
Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králove, Czechia, 500 05
Krajská nemocnice Liberec
Liberec, Czechia, 460 63
Fakultni nemocnice Plzen, Urologicka klinika
Plzen, Czechia, 305 99
France
CHU d'Angers
Angers, France, 49933
Chu Rennes - Hopital Pontchaillou
Rennes Cedex, France, 35033
Germany
Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
Braunschweig, Germany, 38126
Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie
Hamburg, Germany, 20246
Urologikum Hamburg
Hamburg, Germany, 22399
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Universitaetsklinikum Koeln
Koeln, Germany, 50937
Universitätsklinikum Schleswig Holstein Campus Lübeck
Lubeck, Germany, 23538
Israel
Asaf Harofe Medical Center
Beer Yaakov, Israel, 60930
Rambam Health Care Campus
Haifa, Israel, 31096
Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC)
Kfar Saba, Israel, 4428164
Rabin Medical Center
Petach-Tikva, Israel, 49100
The Chaim Sheba Medical Center
Ramat Gan, Israel, 52621
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Italy
ASST Spedali Civili Brescia
Brescia, Italy, 25123
Clinica di Urologia Policlinico di Modena - Università di Modena e reggio Emilia
Modena, Italy, 41100
Università Campus Bio-Medico di Roma
Roma, Italy, 00128
Azienda Ospedaliera Sant Andrea
Roma, Italy, 00189
Ospedale Molinette, AO Città della Salute e della Scienza di
Torino, Italy, 10126
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of, 13605
Netherlands
NKI-AVL, Amsterdam
Amsterdam, Netherlands, 1066 CX
Catharinaziekenhuis
Eindhoven, Netherlands, 5623 EJ
St. Antonius Ziekenhuis (St. Antonius Hospital)
Nieuwegein, Netherlands, 3430EM
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Netherlands, 6524 KD
Poland
Samodzielny Publiczny Wielospecjalistyczny Zakład Opieki Zdrowotnej MSWiA w Bydgoszczy
Bydgoszcz, Poland, 85-015
Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza
Bydgoszcz, Poland, 85-094
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
Koszalin, Poland, 75-581
Malopolskie Centrum Medyczne
Krakow, Poland, 30-510
Centrum Medyczne HCP
Poznań, Poland, 61-485
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
Szczecin, Poland, 70-111
Szpital Św. Elżbiety Mokotowskie Centrum Medyczne
Warszawa, Poland, 02-616
Szpital Mazovia
Warszawa, Poland, 02-797
Miedzyleski Szpital Specjalistyczny
Warszawa, Poland, 04-749
Dolnoslaskie Centrum Onkologii
Wrocław, Poland, 53-413
Pro Salus Medica Sp. z o.o.
Łódź, Poland, 93-228
Spain
Hosp. Univ. A Coruña
A Coruña, Spain, 15006
Hosp. Univ. Vall D Hebron
Barcelona, Spain, 8035
Hosp. Puerta Del Mar
Cadiz, Spain, 11009
Hosp. Gral. Univ. de Castellon
Castellón, Spain, 12004
Hosp. de Jerez de La Frontera
Jerez De La Frontera, Spain, 11407
Hosp. Univ. Ramon Y Cajal
Madrid, Spain, 28034
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Hosp. Univ. La Paz
Madrid, Spain, 28046
Fund. Hosp. de Manacor
Manacor, Spain, 07500
Hosp. Virgen de La Victoria
Málaga, Spain, 29010
Hosp. Univ. Marques de Valdecilla
Santander, Spain, 39008
Hosp. Virgen Del Rocio
Sevilla, Spain, 41013
Hosp. Clinico Univ. de Valencia
Valencia, Spain, 46010
Taiwan
China Medical University Hospital
Taichung, Taiwan, 40447
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Tungs' Taichung MetroHarbor Hospital
Taichung, Taiwan, 435
National Taiwan University Hospital.
Taipei, Taiwan, 10002
United Kingdom
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
Ninewells Hospital
Dundee, United Kingdom, DD2 1UB
University College London
London, United Kingdom, WC1E 6BT
Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital
Preston, United Kingdom, PR2 9HT
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
MidYorkshire NHS Trust
Wakefield, United Kingdom, WF1 4DG
New Cross Hospital
Wolverhampton, United Kingdom, WV10 0QP
Open or close this module IPDSharing
Plan to Share IPD: Yes

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

Supporting Information:
Time Frame:
Access Criteria:
URL: https://www.janssen.com/clinical-trials/transparency
Open or close this module References
Links:
Available IPD/Information:

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