A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)
A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)
4 other identifiers
interventional
1,209
33 countries
208
Brief Summary
The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate plus low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone \[LHRH\] agonists or surgical castration).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2013
Longer than P75 for phase_3
208 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2012
CompletedFirst Posted
Study publicly available on registry
October 26, 2012
CompletedStudy Start
First participant enrolled
February 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2016
CompletedResults Posted
Study results publicly available
October 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2022
CompletedFebruary 4, 2025
January 1, 2025
3.7 years
October 24, 2012
March 9, 2018
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Radiographic Progression-Free Survival (PFS)
Radiographic PFS was defined as the time (in months) interval from randomization to the first date of radiographic progression or death. Radiographic progression included progression by bone scan (according to modified Prostate Cancer Working Group 2 \[PCWG2\] criteria), defined as at least 2 new lesions on bone scan and progression of soft tissue lesions by computed tomography (CT) or magnetic resonance imaging (MRI) (according to Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 criteria). As per the RECIST 1.1 guideline, progression requires a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum as compared to nadir sum of diameter.
Up to 44 months
Overall Survival (OS)
Overall survival was defined as the time from randomization to date of death from any cause.
Up to 66 months
Secondary Outcomes (5)
Time to Initiation of Chemotherapy
Up to 66 months
Time to Subsequent Therapy for Prostate Cancer
Up to 66 months
Time to Pain Progression
Up to 66 months
Time to Skeletal-Related Event
Up to 66 months
Time to Prostate-Specific Antigen (PSA) Progression
Up to 66 months
Study Arms (2)
Abiraterone acetate + Prednisone + ADT
EXPERIMENTALParticipants will receive abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) will be administered.
Placebo + Androgen Deprivation Therapy (ADT)
PLACEBO COMPARATORParticipants will receive placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT will be administered.
Interventions
Abiraterone acetate tablets will be administered orally at a total dose of 1000 mg per day until disease progression, withdrawal of consent or unacceptable toxicity.
Prednisone 5 mg capsule will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
All participants will receive stable regimen of ADT, that is, lutenizing hormone releasing hormone (LHRH) agonists or surgical castration according to local guidelines until disease progression, withdrawal of consent or unacceptable toxicity.
Placebo matched to abiraterone acetate will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
Placebo matched to prednisone will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
Eligibility Criteria
You may qualify if:
- Newly diagnosed metastatic prostate cancer within 3 months prior to randomization with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
- Distant metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan
- At least 2 of the following high-risk prognostic factors: Gleason score of greater than or equal to (\>=8); presence of 3 or more lesions on bone scan; presence of measurable visceral (excluding lymph node disease) metastasis on CT or MRI Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 scan
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2
- Adequate hematologic, hepatic, and renal function
- Agrees to protocol-defined use of effective contraception
You may not qualify if:
- Active infection or other medical condition that would make prednisone use contraindicated
- Any chronic medical condition requiring a higher systemic dose of corticosteroid than 5 mg prednisone per day
- Pathological finding consistent with small cell carcinoma of the prostate
- Known brain metastasis
- Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer (the following exception are permitted): up to 3 months of androgen deprivation therapy (ADT) with lutenizing hormone releasing hormone agonists or antagonists or orchiectomy with or without concurrent anti-androgens prior Cycle 1 Day 1; participants may have one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 28 days prior to Cycle 1 Day 1)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (208)
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Buenos Aires, Argentina
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Caba, Argentina
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Córdoba, Argentina
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La Rioja, Argentina
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Rosario, Argentina
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Adelaide, Australia
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Footscray, Australia
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Liverpool, Australia
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Malvern, Australia
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Randwick, Australia
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Wahroonga, Australia
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Antwerp, Belgium
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Bonheiden, Belgium
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Brasschaat, Belgium
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Brussels, Belgium
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Charleroi, Belgium
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Liège, Belgium
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Namur, Belgium
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Ottignies, Belgium
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Sint-Niklaas, Belgium
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Yvoir, Belgium
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Barretos, Brazil
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Belo Horizonte, Brazil
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Caxias do Sul, Brazil
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Curitiba, Brazil
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Ijuí, Brazil
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Jaú, Brazil
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Natal, Brazil
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Novo Hamburgo, Brazil
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Porto Alegre, Brazil
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Ribeirão Preto, Brazil
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Rio de Janeiro, Brazil
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Salvador, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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Gabrovo, Bulgaria
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Sofia, Bulgaria
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Santiago, Chile
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Beijing, China
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Chengdu, China
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Chongqing, China
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Guangzhou, China
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Hangzhou, China
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Nanjing, China
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Shanghai, China
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Suzhou, China
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Tianjin, China
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Wuhan, China
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Bogotá, Colombia
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Floridablanca, Colombia
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Medellín, Colombia
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Hradec Králové, Czechia
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Olomouc, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Aarhus N, Denmark
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Holsterbro, Denmark
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Odense, Denmark
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Roskilde, Denmark
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Vejle, Denmark
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Oulu, Finland
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Tampere, Finland
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La Chaussée-Saint-Victor, France
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Lille, France
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Montpellier, France
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Paris, France
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Suresnes, France
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Toulouse, France
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Villejuif, France
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Düsseldorf, Germany
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Hamburg, Germany
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Nürtingen, Germany
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Budapest, Hungary
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Győr, Hungary
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Miskolc, Hungary
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Pécs, Hungary
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Szentes, Hungary
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Beer Yaakov, Israel
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Beersheba, Israel
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Haifa, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Petah Tikva, Israel
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Ramat Gan, Israel
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Chiba, Japan
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Gifu, Japan
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Kashiwa, Japan
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Matsuyama, Japan
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Nankoku, Japan
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Ōsaka-sayama, Japan
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Sakura, Japan
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Tokushima, Japan
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Tokyo, Japan
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Ube, Japan
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Yokohama, Japan
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Yufu, Japan
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Kuala Lumpur, Malaysia
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Kuching, Malaysia
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Chihuahua City, Mexico
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Cuernavaca, Mexico
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Durango, Mexico
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Guadalajara, Mexico
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Monterrey, Mexico
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Oaxaca City, Mexico
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Pachuca, Mexico
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Zapopan, Mexico
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Alkmaar, Netherlands
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Amsterdam, Netherlands
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Amsterdam-Zuidoost, Netherlands
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Hilversum, Netherlands
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Hoofddorp, Netherlands
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Nieuwegein, Netherlands
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Rotterdam, Netherlands
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Auckland, New Zealand
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Christchurch, New Zealand
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Hamilton, New Zealand
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Tauranga, New Zealand
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Bydgoszcz, Poland
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Gdansk, Poland
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Lodz, Poland
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Lublin, Poland
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Warsaw, Poland
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Braga, Portugal
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Coimbra, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Brasov, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Iași, Romania
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Chelyabinsk, Russia
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Ivanovo, Russia
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Izhevsk, Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Obninsk, Russia
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Omsk, Russia
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Orenburg, Russia
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Pyatigorsk, Russia
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Rostov-on-Don, Russia
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Ryazan, Russia
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Saint Petersburg, Russia
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Saransk, Russia
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Saratov, Russia
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Sochi, Russia
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Stavropol, Russia
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Tyumen, Russia
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Ufa, Russia
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Volgograd, Russia
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Yekaterinburg, Russia
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Yoshkar-Ola, Russia
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Košice-Šaca, Slovakia
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Martin, Slovakia
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Piešťany, Slovakia
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Prešov, Slovakia
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Rimavská Sobota, Slovakia
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Trnava, Slovakia
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George, South Africa
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Port Elizabeth, South Africa
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Pretoria, South Africa
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Vosloorus, South Africa
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Bucheon-si, South Korea
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Busan, South Korea
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Daegu, South Korea
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Daejeon, South Korea
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Gyeonggi-do, South Korea
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Seoul, South Korea
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A Coruña, Spain
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Barcelona, Spain
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Córdoba, Spain
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Madrid, Spain
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Murcia, Spain
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Gothenburg, Sweden
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Malmo, Sweden
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Stockholm, Sweden
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Umeå, Sweden
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Uppsala, Sweden
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Adana, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Zonguldak, Turkey (Türkiye)
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Cherkassy, Ukraine
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Dnipro, Ukraine
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Khakhiv, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Makiivka, Ukraine
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Odesa, Ukraine
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Uzhhorod, Ukraine
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Zaporizhzhia, Ukraine
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Cambridge, United Kingdom
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Glasgow, United Kingdom
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Manchester, United Kingdom
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Nottingham, United Kingdom
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Oxford, United Kingdom
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Plymouth, United Kingdom
Related Publications (9)
Koroki Y, Taguri M. Clinical Outcomes of First Subsequent Therapies After Abiraterone Acetate Plus Prednisone for High-Risk Metastatic Castration-Sensitive Prostate Cancer in the LATITUDE Study. Target Oncol. 2023 Jan;18(1):119-128. doi: 10.1007/s11523-022-00929-3. Epub 2022 Nov 28.
PMID: 36443540DERIVEDKoroki Y, Taguri M, Matsubara N, Fizazi K. Estimation of Overall Survival with Subsequent Treatment Effect by Applying Inverse Probability of Censoring Weighting in the LATITUDE Study. Eur Urol Open Sci. 2022 Jan 6;36:51-58. doi: 10.1016/j.euros.2021.11.012. eCollection 2022 Feb.
PMID: 35098170DERIVEDBaciarello G, Ozguroglu M, Mundle S, Leitz G, Richarz U, Hu P, Feyerabend S, Matsubara N, Chi KN, Fizazi K. Impact of abiraterone acetate plus prednisone in patients with castration-sensitive prostate cancer and visceral metastases over four years of follow-up: A post-hoc exploratory analysis of the LATITUDE study. Eur J Cancer. 2022 Feb;162:56-64. doi: 10.1016/j.ejca.2021.11.026. Epub 2021 Dec 23.
PMID: 34953443DERIVEDAzad AA, Armstrong AJ, Alcaraz A, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Alekseev B, Iguchi T, Shore ND, Gomez-Veiga F, Rosbrook B, Lee HJ, Haas GP, Stenzl A. Efficacy of enzalutamide in subgroups of men with metastatic hormone-sensitive prostate cancer based on prior therapy, disease volume, and risk. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):274-282. doi: 10.1038/s41391-021-00436-y. Epub 2021 Aug 21.
PMID: 34420037DERIVEDFeyerabend S, Saad F, Perualila NJ, Van Sanden S, Diels J, Ito T, De Porre P, Fizazi K. Adjusting Overall Survival Estimates for Treatment Switching in Metastatic, Castration-Sensitive Prostate Cancer: Results from the LATITUDE Study. Target Oncol. 2019 Dec;14(6):681-688. doi: 10.1007/s11523-019-00685-x.
PMID: 31754962DERIVEDFizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Ozguroglu M, Ye D, Feyerabend S, Protheroe A, Sulur G, Luna Y, Li S, Mundle S, Chi KN. Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial. Lancet Oncol. 2019 May;20(5):686-700. doi: 10.1016/S1470-2045(19)30082-8. Epub 2019 Apr 12.
PMID: 30987939DERIVEDLi T, Franco-Villalobos C, Proskorovsky I, Sorensen SV, Tran N, Sulur G, Chi KN. Medical resource utilization of abiraterone acetate plus prednisone added to androgen deprivation therapy in metastatic castration-naive prostate cancer: Results from LATITUDE. Cancer. 2019 Feb 15;125(4):626-632. doi: 10.1002/cncr.31847. Epub 2018 Dec 6.
PMID: 30521063DERIVEDChi KN, Protheroe A, Rodriguez-Antolin A, Facchini G, Suttman H, Matsubara N, Ye Z, Keam B, Damiao R, Li T, McQuarrie K, Jia B, De Porre P, Martin J, Todd MB, Fizazi K. Patient-reported outcomes following abiraterone acetate plus prednisone added to androgen deprivation therapy in patients with newly diagnosed metastatic castration-naive prostate cancer (LATITUDE): an international, randomised phase 3 trial. Lancet Oncol. 2018 Feb;19(2):194-206. doi: 10.1016/S1470-2045(17)30911-7. Epub 2018 Jan 8.
PMID: 29326030DERIVEDFizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Ozguroglu M, Ye D, Feyerabend S, Protheroe A, De Porre P, Kheoh T, Park YC, Todd MB, Chi KN; LATITUDE Investigators. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2017 Jul 27;377(4):352-360. doi: 10.1056/NEJMoa1704174. Epub 2017 Jun 4.
PMID: 28578607DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
As per protocol the long-term extension (LTE) phase was planned but LTE phase is not included as part of this study hence no data was reported for LTE phase.
Results Point of Contact
- Title
- Senior Director Clinical Development
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2012
First Posted
October 26, 2012
Study Start
February 12, 2013
Primary Completion
October 31, 2016
Study Completion
February 13, 2022
Last Updated
February 4, 2025
Results First Posted
October 15, 2018
Record last verified: 2025-01