Prostate Cancer Clinical Trial
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
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.
Full Description
High-risk prostate cancer accounts for approximately 15 percent (%) of newly diagnosed prostate cancers. A systemic therapy that eradicates micrometastatic disease is needed to improve survival in high-risk participants undergoing RP with pLND. It is hypothesized that androgen blockade prior to and after RP with pLND may improve outcomes for participants at the highest risk for recurrence. This study is designed to evaluate if androgen blockade administered prior to and after RP with pLND will increase the rate of pathological complete response (pCR) and lead to better overall outcomes. ERLEADA (apalutamide, also known as JNJ-56021927 and ARN-509) is an orally available, non-steroidal small molecule, which acts as a potent and selective antagonist of the androgen receptor (AR), currently being developed for the treatment of prostate cancer. The study includes screening phase (approximately up to 35 days before randomization), treatment phase (the planned Treatment Phase will include a total of 12 treatment cycles of apalutamide or placebo; 6 cycles prior to RP with pLND (Cycle 1 through Cycle 6) and 6 cycles after RP with pLND (Cycle 7 through Cycle 12). Cycle 1 Day 1 will start within 3 days after randomization) and follow-up phase. The end of study (study completion) is defined as last participant assessment at study site with approximate study duration of 8 years. Participants will undergo efficacy, pharmacokinetics and biomarker evaluations. The safety will be monitored throughout the study. An open-label sub-study comparing apalutamide plus ADT before and after RP with pLND with standard of care treatment will be initiated at selected sites upon notification by the sponsor.
Eligibility Criteria
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
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 199 Locations for this study
La Jolla California, 92093, United States
Los Angeles California, 90033, United States
Los Angeles California, 90048, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Sacramento California, 95817, United States
Denver Colorado, 80211, United States
Lakewood Colorado, 80228, United States
Stamford Connecticut, 06904, United States
Hialeah Florida, 33002, United States
Jacksonville Florida, 32224, United States
Miami Florida, 33176, United States
Orlando Florida, 32804, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60637, United States
Shreveport Louisiana, 71106, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Troy Michigan, 48084, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68130, United States
Albany New York, 12208, United States
Cheektowaga New York, 14225, United States
New York New York, 10065, United States
New York New York, 10065, United States
Syracuse New York, 13210, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27705, United States
Greensboro North Carolina, 27403, United States
Huntersville North Carolina, 28078, United States
Cleveland Ohio, 44106, United States
Oklahoma City Oklahoma, 73104, United States
Bala-Cynwyd Pennsylvania, 19004, United States
Warwick Rhode Island, 02886, United States
Charleston South Carolina, 29403, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29605, United States
Myrtle Beach South Carolina, 29572, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75216, United States
Houston Texas, 77030, United States
Richmond Virginia, 23235, United States
Virginia Beach Virginia, 23462, United States
Charleston West Virginia, 25304, United States
Caba , 1118, Argentina
Ciudad Autonoma de , C1199, Argentina
Cordoba , 5000, Argentina
Cordoba , X5000, Argentina
Mendoza , 5500, Argentina
San Miguel de Tucuman , 4000, Argentina
Box Hill , 3128q, Australia
Darlinghurst , 2010, Australia
Heidelberg , 3084, Australia
Malvern , 3144, Australia
Parkville , 3050, Australia
St Leonards , 2065, Australia
Wahroonga , 2076, Australia
Westmead , 2145, Australia
Woolloongabba , 4102, Australia
Goiania , 74605, Brazil
Ijui , 98700, Brazil
Natal , 59075, Brazil
Porto Alegre , 90020, Brazil
Rio de Janeiro , 20551, Brazil
Sao Paulo , 01232, Brazil
Sao Paulo , 01246, Brazil
Três Lagoas , 79601, Brazil
Calgary Alberta, T2V 1, Canada
Vancouver British Columbia, V5Z 1, Canada
Halifax Nova Scotia, B3H 2, Canada
London Ontario, N6A 5, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2X 0, Canada
Quebec , G1R 2, Canada
Hradec Králove , 500 0, Czechia
Liberec , 460 6, Czechia
Olomouc , 77200, Czechia
Plzen , 305 9, Czechia
Praha 4 , 140 5, Czechia
Praha , 120 0, Czechia
Angers , 49933, France
Besançon Cedex , 25030, France
Bordeaux N/a , 33076, France
Créteil , 94010, France
Lyon cedex 03 , 69437, France
Nantes , 44000, France
Paris , 75014, France
Quint-Fonsegrives , 31130, France
Rennes Cedex , 35033, France
Toulouse Cedex 9 , 31059, France
Tours , 37000, France
Aachen , 52074, Germany
Braunschweig , 38126, Germany
Essen , 45147, Germany
Frankfurt am Main , 60590, Germany
Gronau , 48599, Germany
Hamburg , 20246, Germany
Homburg/Saar , 66421, Germany
Koeln , 50937, Germany
Lubeck , 23538, Germany
Lutherstadt Eisleben , 06295, Germany
Straubing , 94315, Germany
Weiden/Opf , 92637, Germany
Wilhelmshaven , 26389, Germany
Beer Yaakov , 60930, Israel
Haifa , 31096, Israel
Kfar Saba , 44281, Israel
Petach Tikva , 49100, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Abano Terme , 35031, Italy
Acquaviva delle Fonti , 70021, Italy
Bassano del Grappa , 36061, Italy
Brescia , 25123, Italy
Chieti , 66100, Italy
Firenze , 50134, Italy
MIlano , 20127, Italy
Milano , 20132, Italy
Milano , 20141, Italy
Modena , 41100, Italy
Novara , 28100, Italy
Orbassano , 10043, Italy
Roma , 00128, Italy
Roma , 00144, Italy
Roma , 00189, Italy
Torino , 10126, Italy
Verona , 37126, Italy
Akita , 010-8, Japan
Chiba , 260-8, Japan
Chuo-ku, Chiba-City, , 260-8, Japan
Hakodate , 040-8, Japan
Hirosaki , 036-8, Japan
Kanazawa , 920-8, Japan
Kobe , 650-0, Japan
Koshigaya , 343-8, Japan
Kurume , 830-0, Japan
Kyoto , 606-8, Japan
Matsuyama , 791-0, Japan
Minami-Ku, Sagamihara-Shi , 252-0, Japan
Miyazaki , 889-1, Japan
Nagano , 381-8, Japan
Osaka-Sayama-shi , 589-8, Japan
Osaka , 541-8, Japan
Sakura , 285-8, Japan
Sapporo-shi , 060-8, Japan
Shiwa-gun , 028-3, Japan
Tokyo , 113-8, Japan
Tokyo , 113-8, Japan
Ube , 755-8, Japan
Yokohama , 232-0, Japan
Gwangju , 61469, Korea, Republic of
Gyeonggi-do , 13605, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06591, Korea, Republic of
Amsterdam , 1066 , Netherlands
Eindhoven , 5623 , Netherlands
Nieuwegein , 3430E, Netherlands
Nijmegen , 6524 , Netherlands
Bydgoszcz , 85-01, Poland
Bydgoszcz , 85-09, Poland
Koszalin , 75-58, Poland
Krakow , 30-72, Poland
Warszawa , 02-47, Poland
Wrocław , 53-41, Poland
Barnaul , 65604, Russian Federation
Chelyabinsk , 45408, Russian Federation
Moscow , 12513, Russian Federation
Moscow , 12528, Russian Federation
Omsk , 64401, Russian Federation
Tyumen , 62500, Russian Federation
Vologda , 16001, Russian Federation
A Coruña , 15006, Spain
Barcelona , 8035, Spain
Cadiz , 11009, Spain
Castellón , 12004, Spain
Jerez de la Frontera , 11407, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Manacor , 07500, Spain
Málaga , 29010, Spain
Santander , 39008, Spain
Sevilla , 41013, Spain
Valencia , 46009, Spain
Valencia , 46010, Spain
Kaohsiung , 807, Taiwan
Taichung , 40447, Taiwan
Taichung , 40705, Taiwan
Taichung , 435, Taiwan
Tainan , 710, Taiwan
Taipei , 10002, Taiwan
Bristol , BS10 , United Kingdom
Cardiff , CF14 , United Kingdom
Dundee , DD2 1, United Kingdom
London , SW3 6, United Kingdom
London , WC1E , United Kingdom
Preston , PR2 9, United Kingdom
Sutton , SM2 5, United Kingdom
Wakefield , WF1 4, United Kingdom
Wolverhampton , WV10 , United Kingdom
How clear is this clinincal trial information?