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AzTrials

Prostate NeoplasmsPhase 3NCT01715285

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 Phase 3 study testing Abiraterone acetate, Prednisone and Androgen deprivation therapy (ADT) in people with Prostate Neoplasms, run by Janssen Research & Development, LLC at 208 sites in 33 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Neoplasms
What is being tested?
Abiraterone acetate, Prednisone and Androgen deprivation therapy (ADT)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,209 participants
Where
208 sitesin 33 countries
Study dates
12 Feb 2013to 13 Feb 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

208 sites in 33 countries.

208 sites in 33 countries

Russia21 sites

  • Study site

    Chelyabinsk

  • Study site

    Ivanovo

  • Study site

    Izhevsk

  • Study site

    Moscow

  • Study site

    Nizhny Novgorod

  • Study site

    Obninsk

  • Study site

    Omsk

  • Study site

    Orenburg

  • Study site

    Pyatigorsk

  • Study site

    Rostov-on-Don

  • Study site

    Ryazan

  • Study site

    Saint Petersburg

  • Study site

    Saransk

  • Study site

    Saratov

  • Study site

    Sochi

  • Study site

    Stavropol

  • Study site

    Tyumen

  • Study site

    Ufa

  • Study site

    Volgograd

  • Study site

    Yekaterinburg

  • Study site

    Yoshkar-Ola

Other trials in Russia

Brazil14 sites

  • Study site

    Barretos

  • Study site

    Belo Horizonte

  • Study site

    Caxias do Sul

  • Study site

    Curitiba

  • Study site

    Ijuí

  • Study site

    Jaú

  • Study site

    Natal

  • Study site

    Novo Hamburgo

  • Study site

    Porto Alegre

  • Study site

    Ribeirão Preto

  • Study site

    Rio de Janeiro

  • Study site

    Salvador

  • Study site

    São José do Rio Preto

  • Study site

    São Paulo

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Japan12 sites

  • Study site

    Chiba

  • Study site

    Gifu

  • Study site

    Kashiwa

  • Study site

    Matsuyama

  • Study site

    Nankoku

  • Study site

    Ōsaka-sayama

  • Study site

    Sakura

  • Study site

    Tokushima

  • Study site

    Tokyo

  • Study site

    Ube

  • Study site

    Yokohama

  • Study site

    Yufu

Other trials in Japan

Belgium10 sites

  • Study site

    Antwerp

  • Study site

    Bonheiden

  • Study site

    Brasschaat

  • Study site

    Brussels

  • Study site

    Charleroi

  • Study site

    Liège

  • Study site

    Namur

  • Study site

    Ottignies

  • Study site

    Sint-Niklaas

  • Study site

    Yvoir

Other trials in Belgium

Canada10 sites

  • Study site

    Edmonton, Alberta

  • Study site

    Hamilton, Ontario

  • Study site

    Kingston, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Oshawa, Ontario

  • Study site

    Ottawa, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

China10 sites

  • Study site

    Beijing

  • Study site

    Chengdu

  • Study site

    Chongqing

  • Study site

    Guangzhou

  • Study site

    Hangzhou

  • Study site

    Nanjing

  • Study site

    Shanghai

  • Study site

    Suzhou

  • Study site

    Tianjin

  • Study site

    Wuhan

Other trials in China

Ukraine10 sites

  • Study site

    Cherkassy

  • Study site

    Dnipro

  • Study site

    Khakhiv

  • Study site

    Kharkiv

  • Study site

    Kyiv

  • Study site

    Lviv

  • Study site

    Makiivka

  • Study site

    Odesa

  • Study site

    Uzhhorod

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Mexico8 sites

  • Study site

    Chihuahua City

  • Study site

    Cuernavaca

  • Study site

    Durango

  • Study site

    Guadalajara

  • Study site

    Monterrey

  • Study site

    Oaxaca City

  • Study site

    Pachuca

  • Study site

    Zapopan

Other trials in Mexico

France7 sites

  • Study site

    La Chaussée-Saint-Victor

  • Study site

    Lille

  • Study site

    Montpellier

  • Study site

    Paris

  • Study site

    Suresnes

  • Study site

    Toulouse

  • Study site

    Villejuif

Other trials in France

Israel7 sites

  • Study site

    Beer Yaakov

  • Study site

    Beersheba

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Kfar Saba

  • Study site

    Petah Tikva

  • Study site

    Ramat Gan

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Netherlands7 sites

  • Study site

    Alkmaar

  • Study site

    Amsterdam

  • Study site

    Amsterdam-Zuidoost

  • Study site

    Hilversum

  • Study site

    Hoofddorp

  • Study site

    Nieuwegein

  • Study site

    Rotterdam

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Australia6 sites

  • Study site

    Adelaide

  • Study site

    Footscray

  • Study site

    Liverpool

  • Study site

    Malvern

  • Study site

    Randwick

  • Study site

    Wahroonga

Other trials in Australia

Slovakia6 sites

  • Study site

    Košice-Šaca

  • Study site

    Martin

  • Study site

    Piešťany

  • Study site

    Prešov

  • Study site

    Rimavská Sobota

  • Study site

    Trnava

Other trials in Slovakia

South Korea6 sites

  • Study site

    Bucheon-si

  • Study site

    Busan

  • Study site

    Daegu

  • Study site

    Daejeon

  • Study site

    Gyeonggi-do

  • Study site

    Seoul

Other trials in South Korea

United Kingdom6 sites

  • Study site

    Cambridge

  • Study site

    Glasgow

  • Study site

    Manchester

  • Study site

    Nottingham

  • Study site

    Oxford

  • Study site

    Plymouth

Other trials in United Kingdom

Argentina5 sites

  • Study site

    Buenos Aires

  • Study site

    Caba

  • Study site

    Córdoba

  • Study site

    La Rioja

  • Study site

    Rosario

Other trials in Argentina

Denmark5 sites

  • Study site

    Aarhus N

  • Study site

    Holsterbro

  • Study site

    Odense

  • Study site

    Roskilde

  • Study site

    Vejle

Other trials in Denmark

Hungary5 sites

  • Study site

    Budapest

  • Study site

    Győr

  • Study site

    Miskolc

  • Study site

    Pécs

  • Study site

    Szentes

Other trials in Hungary

Poland5 sites

  • Study site

    Bydgoszcz

  • Study site

    Gdansk

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Warsaw

Other trials in Poland

Spain5 sites

  • Study site

    A Coruña

  • Study site

    Barcelona

  • Study site

    Córdoba

  • Study site

    Madrid

  • Study site

    Murcia

Other trials in Spain

Sweden5 sites

  • Study site

    Gothenburg

  • Study site

    Malmö

  • Study site

    Stockholm

  • Study site

    Umeå

  • Study site

    Uppsala

Other trials in Sweden

Turkey (Türkiye)5 sites

  • Study site

    Adana

  • Study site

    Ankara

  • Study site

    Istanbul

  • Study site

    Izmir

  • Study site

    Zonguldak

Other trials in Turkey (Türkiye)

Czechia4 sites

  • Study site

    Hradec Králové

  • Study site

    Olomouc

  • Study site

    Pilsen

  • Study site

    Prague

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New Zealand4 sites

  • Study site

    Auckland

  • Study site

    Christchurch

  • Study site

    Hamilton

  • Study site

    Tauranga

Other trials in New Zealand

Portugal4 sites

  • Study site

    Braga

  • Study site

    Coimbra

  • Study site

    Lisbon

  • Study site

    Porto

Other trials in Portugal

Romania4 sites

  • Study site

    Brasov

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Iași

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South Africa4 sites

  • Study site

    George

  • Study site

    Port Elizabeth

  • Study site

    Pretoria

  • Study site

    Vosloorus

Other trials in South Africa

Colombia3 sites

  • Study site

    Bogotá

  • Study site

    Floridablanca

  • Study site

    Medellín

Other trials in Colombia

Germany3 sites

  • Study site

    Düsseldorf

  • Study site

    Hamburg

  • Study site

    Nürtingen

Other trials in Germany

Bulgaria2 sites

  • Study site

    Gabrovo

  • Study site

    Sofia

Other trials in Bulgaria

Finland2 sites

  • Study site

    Oulu

  • Study site

    Tampere

Other trials in Finland

Malaysia2 sites

  • Study site

    Kuala Lumpur

  • Study site

    Kuching

Other trials in Malaysia

Chile1 site

  • Study site

    Santiago

Other trials in Chile

About this study

Official title: 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)

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).

Read the detailed description

This is a randomized (the treatment group is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study designed to determine the efficacy of abiraterone acetate plus low-dose prednisone in participants with mHNPC. The study consists of 4 parts: Screening Phase (that is, 28 days before study commences on Day 1); Double-blind treatment Phase (consists of 4-week dosing cycles wherein abiraterone acetate will be administered as 1,000 milligram [mg] plus 5 mg prednisone or only placebo orally); Follow-up Phase (every 4 months up to 60 months or until death, lost to follow up, withdrawal of consent or study termination) Open-label Extension (OLE) Phase. Participants in the Double-blind Treatment Phase will have the opportunity to enroll into the OLE Phase. The OLE Phase will allow participants to receive active drug (abiraterone acetate plus prednisone) until Long-term Extension (LTE) Phase for an additional period of up to 3 years. Participants will discontinue study treatment at disease progression or unacceptable toxicity unless, in the Investigator's opinion, it is deemed that the participants will continue to derive benefit from study treatment. Participants will be randomized in a 1:1 ratio to the active treatment group (abiraterone acetate 1000 mg daily plus prednisone 5 mg daily plus ADT) or the control group (ADT plus placebos).Efficacy will be evaluated primarily by overall survival and radiographic progression-free survival. Participants' safety will be monitored throughout the study.

Being tested
Abiraterone acetate, Prednisone, Androgen deprivation therapy (ADT), Abiraterone acetate Placebo, Prednisone Placebo
Keywords
Prostate neoplasms, Prostate cancer, Metastatic prostate cancer, Abiraterone acetate, ZYTIGA, Prednisone, Androgen deprivation therapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abiraterone acetateDrug

    Also called Zytiga

    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.

  • PrednisoneDrug

    Prednisone 5 mg capsule will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.

  • Androgen deprivation therapy (ADT)Other

    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.

  • Abiraterone acetate PlaceboDrug

    Placebo matched to abiraterone acetate will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.

  • Prednisone PlaceboDrug

    Placebo matched to prednisone will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.

Study groups in NCT01715285
Study groupRoleWhat they receive
Abiraterone acetate + Prednisone + ADTExperimentalParticipants 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.
Receives: Drug: Abiraterone acetate; Drug: Prednisone; Other: Androgen deprivation therapy (ADT)
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.
Receives: Other: Androgen deprivation therapy (ADT); Drug: Abiraterone acetate Placebo; Drug: Prednisone Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 44 months

  2. Overall Survival (OS)

    Overall survival was defined as the time from randomization to date of death from any cause.

    Measured: Up to 66 months

Secondary outcomes (5)

  1. Time to Initiation of Chemotherapy

    Time to initiation of chemotherapy was defined as the time (in months) interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.

    Measured: Up to 66 months

  2. Time to Subsequent Therapy for Prostate Cancer

    Time to subsequent therapy was defined as the time (in months) interval from the date of randomization to the date of initiation of subsequent therapy for prostate cancer.

    Measured: Up to 66 months

  3. Time to Pain Progression

    Time to pain progression was defined as the time (in months) interval from randomization to the first date a participant experienced a greater than or equal to (>=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (>=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing "no pain" and 10 representing" pain as bad as you can imagine.

    Measured: Up to 66 months

  4. Time to Skeletal-Related Event

    Time to skeletal-related event was defined as the earliest of the following: clinical or pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone.

    Measured: Up to 66 months

  5. Time to Prostate-Specific Antigen (PSA) Progression

    Time to PSA progression was defined as the time (in months) interval from the date of randomization to the date of PSA progression, according to PCWG2 criteria. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.

    Measured: Up to 66 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2012 (estimated)
  2. Study start12 Feb 2013
  3. Primary completion31 Oct 2016
  4. Study completion13 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01715285
Sponsor's protocol ID
CR100900
Other IDs
212082PCR3011, 2012-002940-26, U1111-1135-7146
Status last verified
Jan 2025
First submitted
24 Oct 2012
Last updated
4 Feb 2025
Data monitoring committee
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 36443540

  • Koroki 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.

    PubMed 35098170

  • Baciarello 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.

    PubMed 34953443

  • Azad 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.

    PubMed 34420037

  • Feyerabend 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.

    PubMed 31754962

  • Fizazi 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.

    PubMed 30987939

  • Li 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.

    PubMed 30521063

  • Chi 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.

    PubMed 29326030

  • Fizazi 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.

    PubMed 28578607

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abiraterone acetate, Prednisone and Androgen deprivation therapy (ADT) in people with Prostate Neoplasms, run by Janssen Research & Development, LLC at 208 sites in 33 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 208 sites in Russia, Brazil, Japan, Belgium, Canada and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progression-Free Survival (PFS) (time frame: Up to 44 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01715285, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.

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