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Prostate CancerPhase 3PEACE IIINCT02194842

Phase III Radium 223 mCRPC-PEACE III

A Phase 3 study testing Ra223 and Enzalutamide in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 64 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The primary objective of the trial is to assess if upfront combination of enzalutamide and Ra223 improves radiological progression-free survival (rPFS1) by investigator assessment compared to enzalutamide single agent in castration resistant prostate cancer (CRPC) patients metastatic to bone Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Ra223 and Enzalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
446 participants
Where
64 sitesin 12 countries
Study dates
Oct 2015to Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Histologically confirmed diagnosis of prostate adenocarcinoma
  • Asymptomatic or mildly symptomatic (defined as short form question #3 in Brief Pain Inventory worst pain must be < 4, see Appendix E)
  • Metastatic to bone with ≥ 4 bone metastases (ambiguous areas of increased uptake on 99mTc Bone Scan (BS) should be confirmed by CT or MRI) with or without additional lymph node metastases.
  • Patients with visceral metastases are not allowed. Patients with multifocal bone lesions are allowed; while patients with diffuse confluent bone lesions (superscan) are not allowed in the trial.
  • Note: Patients must start treatment with a bone protecting agent (at doses used to reduce the incidence of skeletal related events) ideally before or at the time of randomization, if patient is not already on one. A minimum of two doses is recommended before the first administration of Ra223 in the experimental arm. The first administration of Ra223 should be scheduled at least 6 weeks after the first administration of bone protecting agent.
  • Note: For French sites only, patients must not have undergone a PET/CT scan for restaging prostate cancer using radiopharmaceuticals such as 18F-FDG, 18F-fluoride, 18F-Fluorocholine or a PSMA (prostate-specific membrane antigen) ligand or any other tracer.
Show all 68Show fewer
  • Progressive CRPC according to Prostate Cancer Working Group 3 (PCWG3) (Ref. 22) i.e. either:
  • For patients who manifest disease progression solely as a rising PSA level, PCWG3 criteria require documentation of a sequence of rising PSA values at a minimum of 1-week intervals with the last value > 2 ng/mL
  • For patients with disease progression manifest in the bone, irrespective of progression by rising PSA, PCWG3 guidelines require appearance of 2 or more new lesions. Ambiguous results should be confirmed by other imaging modalities than bone scan (e.g.: CT-scan or MRI)
  • For patients with disease progression manifest at nodal sites, irrespective of progression by rising PSA, PCWG3 requires progression according to RECIST 1.1
  • Ongoing androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist or antagonist or bilateral orchiectomy
  • No known central nervous system metastases or leptomeningeal tumor spread.
  • Patients must be at least 18 years old
  • WHO Performance status 0-1(see Appendix C)
  • Charlson score ≤ 3 (see Appendix G)
  • T-score ≥ -2.5 on a DXA scan done in the past 12 months Note: For French sites only, DXA scan done within 6 weeks of randomization
  • Castrate serum levels of testosterone < 50 ng/dL
  • Biochemistry and hematology:
  • Adequate bone marrow function (absolute neutrophil count (ANC) ≥ 1.5 109/L; platelets ≥100 109/L, and hemoglobin ≥ 10.0 g/dL)
  • Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN), except for patient with Gilbert's disease where ≤ 5.0 × ULN applies
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
  • Creatinine ≤ 1.5 x ULN
  • Albumin > 25 g/L
  • Normal cardiac function according to local standard by 12-lead ECG (complete, standardized 12-lead recording)
  • No significant cardiovascular disease including:
  • Myocardial infarction within 6 months prior to screening
  • Uncontrolled angina within 3 months prior to screening
  • Congestive heart failure New York Heart Association (NYHA) class III or IV, or patients with history of congestive heart failure NYHA class III or IV in the past, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is ≥ 45%
  • History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)
  • History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
  • Uncontrolled hypertension as indicated by a resting systolic blood pressure > 140 millimeters of mercury (mm Hg) or diastolic blood pressure > 90 mm Hg at screening.
  • Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to randomization. Blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour. The mean SBP / DBP values from all blood pressure assessment timepoints must be ≤140/90 mm Hg in order for a patient to be eligible for the study.
  • Hypotension as indicated by systolic blood pressure < 86 mm Hg at screening
  • Bradycardia as indicated by a heart rate of < 45 beats per minute on the screening ECG and on physical examination
  • Uncontrolled hyperglycemia as indicated by a fasting glucose ≥ 7 mmol/L
  • Able to swallow the study drug and comply with study requirements
  • Prior or concomitant therapy
  • Prior docetaxel is permitted if given in the castration sensitive state and if it was started within 4 months of ADT initiation Note: patients having received docetaxel for CRPC are excluded.
  • Prior use of abiraterone is permitted if the patient had a response or stable disease on abiraterone for a minimum of 1 year for metastatic castration sensitive prostate cancer
  • Note: patients having received abiraterone for CRPC are excluded. Prior treatment with abiraterone is allowed if it was stopped at least 4 weeks prior to randomization
  • No prior treatment with enzalutamide, apalutamide, darolutamide or Ra223
  • No concomitant treatment with Cyp17 inhibitors (abiraterone, orteronel) and ketoconazole
  • Previous treatment with bicalutamide or flutamide is allowed if it was stopped at least 48 hours prior to randomization
  • Corticosteroids are allowed only at a dose ≤ 10 mg of prednisone (or equivalent) no matter the indication
  • No prior hemibody external radiotherapy. Patients who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count and platelets
  • No prior therapy with other radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188)
  • No involvement in another therapeutic trial involving an experimental drug
  • No anticancer therapy (except ADT) or treatment with another investigational agent within the last 4 weeks prior to randomization
  • No known hypersensitivity to compounds related to enzalutamide or Ra223 (refer to Investigator's brochures)
  • No prior history of malignancies other than prostate adenocarcinoma (except patients with basal cell, squamous cell carcinoma of the skin, in-situ carcinoma or low-grade superficial bladder cancer), or the patient has been free of malignancy for a period of 3 years prior to randomization date
  • No history of seizure, including any febrile seizure, loss of consciousness, or transient ischemic attack within 12 months of randomization, OR any condition that may pre-dispose to seizure (e.g., prior stroke, brain arterio-venous malformation, head trauma with loss of consciousness requiring hospitalization)
  • Drugs known to lower the seizure threshold or prolong QT interval are not permitted (refer to section 5.9.3.2)
  • No major surgery within 4 weeks prior to treatment
  • No drug or alcohol abuse
  • No other serious illness or medical condition, such as but not limited to:
  • Any infection ≥ Grade 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4
  • No gastrointestinal disorder affecting absorption (e.g., gastrectomy or active peptic ulcer disease)
  • Crohn's disease or ulcerative colitis
  • Osteonecrosis of the jaw
  • Any bone disease with an osteoblastic activity
  • Bone marrow dysplasia
  • Fecal incontinence
  • Life-threatening illness unrelated to cancer
  • No condition which, in the investigator's opinion, makes the patient unsuitable for trial participation
  • Participants who have pregnant partners must use a condom and those with partners of childbearing potential must use a condom and another adequate birth control measure if engaging in sexual activities during the study treatment period and for at least 3 months after last dose of enzalutamide and 6 months after the last dose of Ra223. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  • Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations
  • For participation in translational research, specific consent must be given. Important note: All eligibility criteria must be adhered to, in case of deviation discussion with EORTC Headquarters and study coordinator is mandatory

Who cannot join

  • No known history of central nervous system metastases or leptomeningeal tumor spread.
  • No significant cardiovascular disease including:
  • Myocardial infarction within 6 months prior to screening
  • Uncontrolled angina within 3 months prior to screening
  • Congestive heart failure New York Heart Association (NYHA) class III or IV, or patients with history of congestive heart failure NYHA class III or IV in the past, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is ≥ 45%
  • History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)
Show all 31Show fewer
  • History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
  • Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg at screening
  • Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mm Hg) at screening
  • Bradycardia as indicated by a heart rate of < 45 beats per minute on the screening ECG and on physical examination
  • patients having received docetaxel for CRPC are excluded.
  • No prior treatment with enzalutamide or Ra223
  • No prior and concomitant treatment with Cyp17 inhibitors (abiraterone, orteronel) and ketoconazole
  • No prior hemibody external radiotherapy. Patients who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count and platelets
  • No prior therapy with other radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188)
  • No involvement in another therapeutic trial involving an experimental drug
  • No anticancer therapy or treatment with another investigational agent within the last 4 weeks prior to randomization
  • No known hypersensitivity to compounds related to enzalutamide or Ra223
  • No prior history of malignancies other than prostate adenocarcinoma (except patients with basal cell, squamous cell carcinoma of the skin, in-situ carcinoma or low-grade superficial bladder cancer), or the patient has been free of malignancy for a period of 3 years prior to randomization date
  • No history of seizure, including any febrile seizure, loss of consciousness, or transient ischemic attack within 12 months of enrollment (registration date), or any condition that may pre-dispose to seizure (e.g., prior stroke, brain arterio-venous malformation, head trauma with loss of consciousness requiring hospitalization)
  • No major surgery within 4 weeks prior to treatment
  • No intake of narcotic analgesia for bone pain
  • No drug or alcohol abuse
  • No other serious illness or medical condition, such as but not limited to:
  • Any infection ≥ Grade 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4
  • No gastrointestinal disorder affecting absorption (e.g., gastrectomy or active peptic ulcer disease)
  • Crohn's disease or ulcerative colitis
  • Bone marrow dysplasia
  • Fecal incontinence
  • Life-threatening illness unrelated to cancer
  • No condition which, in the investigator's opinion, makes the patient unsuitable for trial participation

Trial locations and contacts

64 sites in 12 countries.

64 sites in 12 countries

Brazil13 sites

  • Hospital de Amor

    Barretos, 14.784-400

  • Hospital Erasto Gaertner

    Curitiba, 81520-060

  • Centro Pesquisas Oncologicas

    Florianópolis, 88034000

  • Oncocentro

    Fortaleza, 60130-241

  • Hospital Moinhos de Vento

    Porto Alegre, 90035-001

  • Centro de Pesquisas Clinicas em Oncologia - Hospital Sao Lucas

    Porto Alegre, 90610 000

  • Instituto de Medicina Integral Professor Fernando Figueira - IMIP

    Recife, 50070-550

  • Centro de Tratamentos de Tumores Botafogo

    Rio de Janeiro, 22250-040

  • Clínica Oncológica - CLION

    Salvador, 41810-570

  • Centro de Estudos e Pesquisa Hematologia e Oncologia

    Santo André, 09060-650

  • Hospital Beneficencia Portuguesa

    São Paulo, 01321-000

  • Hospital Paulistano

    São Paulo, 01321-001

  • Sao Camilo Oncologia - Instituto Brasileiro de Controle do Cancer

    São Paulo, 03.102-002

Other trials in Brazil

Spain10 sites

  • Hospital Del Mar

    Barcelona, 08003

  • Vall d'Hebron Institut d'Oncologia

    Barcelona, 08035

  • Hospital Clinic Universitari de Barcelona

    Barcelona, 08036

  • Hospital De La Santa Creu I Sant Pau

    Barcelona, 08041

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario QuironSalud

    Madrid, 28223

  • Complejo Hospitalario de Navarra

    Pamplona, 31008

  • Corporacio Sanitaria Parc Tauli

    Sabadell

  • Hospital Universitario de Salamanca

    Salamanca, 37007

Other trials in Spain

Belgium8 sites

  • Hopital Universitaire Brugmann

    Brussels, 1020

  • Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • AZ Groeninge Kortrijk

    Kortrijk

  • U.Z. Leuven - Campus Gasthuisberg

    Leuven, 3000

  • AZ Turnhout

    Turnhout

  • CHU Dinant Godinne - UCL Namur

    Yvoir, 5530

Other trials in Belgium

Canada8 sites

  • Centre de sante et de services sociaux de Chicoutimi

    Chicoutimi, Quebec, G7H 5H6

  • Hamilton And District Urology Association

    Hamilton, Ontario, L8N 1T8

  • London Regional Cancer Center

    London, Ontario, N6A 4L6

  • CHUM - Centre Hospitalier de l'Université de Montreal - Pavillon Saint-Luc

    Montreal, Quebec, H2X 3J4

  • Chuq-Pavillon Hotel-Dieu De Quebec

    Québec, Quebec, G1R 2J6

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4

  • Odette Cancer Centre - Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • University Health Network - Oci Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

France8 sites

  • Institut de Cancerologie de l'Ouest (ICO) - Centre Paul Papin

    Angers, 49055

  • Centre Francois Baclesse

    Caen, 14076

  • Assistance Publique - Hopitaux de Paris - CHU Henri Mondor

    Créteil, 94000

  • Centre Leon Berard

    Lyon, 69008

  • Institut régional du Cancer Montpellier

    Montpellier, 34298

  • Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau

    Saint-Herblain, 44805

  • Hopitaux Universitaires de Strasbourg - Hôpitaux Universitaires de Strasbourg - Hôpital civil

    Strasbourg, 67091

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

United Kingdom4 sites

  • United Lincolnshire Hospitals NHS Trust - Lincoln County Hospital

    Lincoln, LN2 5QY

  • Royal Marsden Hospital - Chelsea, London

    London, SW3 6JJ

  • The Christie NHS Foundation Trust

    Manchester

  • Nottingham University Hospitals NHS Trust - City Hospital

    Nottingham

Other trials in United Kingdom

Ireland3 sites

  • Cork University Hospital

    Cork, TI2DC4A

  • St. Vincent's University Hospital

    Dublin

  • Tallaght University Hospital

    Dublin

Other trials in Ireland

Italy3 sites

  • Ospedale B.Ramazzini

    Carpi, 41012

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola

  • Istituto Europeo di Oncologia

    Milan

Other trials in Italy

Switzerland3 sites

  • Oncology Institute of Southern Switzerland - Ospedale San Giovanni

    Bellinzona, 6500

  • Kantonsspital St Gallen

    Sankt Gallen

  • UniversitaetsSpital Zurich

    Zurich, 8091

Other trials in Switzerland

Norway2 sites

  • Soerlandet Sykehus-Kristiansand

    Kristiansand, 4604

  • University Hospital of North Norway

    Tromsø, N-9038

Other trials in Norway

Denmark1 site

  • Rigshospitalet

    Copenhagen

Other trials in Denmark

Poland1 site

  • Maria Sklodowska-Curie Memorial Cancer Centre

    Warsaw

Other trials in Poland

About this study

Official title: A Randomized Multicenter Phase III Trial Comparing Enzalutamide vs. a Combination of Ra223 and Enzalutamide in Asymptomatic or Mildly Symptomatic Castration Resistant Prostate Cancer Patients Metastatic to Bone.

The primary objective of the trial is to assess if upfront combination of enzalutamide and Ra223 improves radiological progression-free survival (rPFS1) by investigator assessment compared to enzalutamide single agent in castration resistant prostate cancer (CRPC) patients metastatic to bone

Conditions
Prostate Cancer
Being tested
Ra223, Enzalutamide
Keywords
metastatic, prostate cancer
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

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

Study groups in NCT02194842
Study groupRoleWhat they receive
EnzalutamideActive comparatorEnzalutamide will be given at a dose of 160 mg daily
Receives: Drug: Enzalutamide
Enzalutamide and Ra223ExperimentalRa223 will be administered 55kBq/kg standard dose monthly for 6 months and given in combination with enzalutamide at a dose of 160 mg daily.
Receives: Drug: Ra223; Drug: Enzalutamide

What is being measured

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

  1. radiological progression-free survival

    Radiological progression free survival (rPFS1) is defined according to the recommendations of the "Prostate-Cancer clinical trials Working Group" version 3 and referred to as the "PCWG3"; for the setting "delay/prevent" progression.

    An event of progression according to their definition is either of:

    • Objective progression of the disease according to RECIST 1.1 criteria for soft tissue lesions
    • A skeletal radiological progression defined as the appearance of ≥ 2 new bone lesions and for the first follow-up assessment only (i.e., within 12 weeks ± 1 week, during the flare period), a confirmatory scan performed ≥ 6 weeks later that shows a minimum of two or more additional new lesions (2+2 criterion) In this protocol: PSA progression is not considered disease progression and should NOT trigger a change of treatment.

    The rPFS1 endpoint is subject to a retrospective Blinded Independent Central Review

    Measured: 46 months after first patient entry

  2. progression-free survival per Blinded Independent Central Review (PFS1B)

    PFS1 per BICR will be defined and analyzed in the same manner as the primary endpoint rPFS1 by investigator assessment. The central reviewers will provide timepoint assessments of skeletal and nonskeletal progression and determinations of respective progression dates from which PFS1 per BICR will be calculated.

    Measured: 96 months after first patient entry

Secondary outcomes (12)

  1. Overall survival

    number of participants

    Measured: 63 months after first patient entry

  2. prostate cancer specific survival

    number of participants

    Measured: 63 months after first patient entry

  3. Time to First symptomatic skeletal event (TTSSE)

    number of participants

    Measured: 46 and 63 months after first patient entry

  4. Time to first skeletal progression

    number of months

    Measured: 46 and 63 months after first patient entry

  5. Time from entry to initiation of next systemic anti-neoplastic therapy (TTNT)

    number of participants

    Measured: 46 and 63 months after first patient entry

  6. Progression-free survival on second line of treatment (PFS2)

    number of participants

    Measured: 46 and 63 months after first patient entry

  7. Patient self-rate scale assessing the pain associated to prostate cancer

    Brief Pain Inventory questionnaire: BPI questionnaire is a validated instrument that is a patient self-rated scale assessing level of pain, effect of the pain on activities of daily living, and analgesic use. The BPI also measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The short form of the BPI is used in this study. It is intended to capture two dimensions of pain: severity and interference. This short version of the BPI contains four pain severity items and seven pain interference items rated on 0-10 scales and uses a 24-hour recall period.

    Measured: 46 and 63 months after first patient entry

  8. Time to pain progression (TTPP)

    defined as an increase of 2 or more points in the "worst pain in 24 hours" score from baseline observed at 2 consecutive evaluations ≥ 4 weeks apart OR initiation of short or long-acting opioid use for pain

    Measured: 63 months after first patient entry

  9. Occurence of adverse events

    Adverse events will be graded according to the "Common Terminology Criteria for Adverse events" CTCAE, version 4.0

    Measured: 63 months after first patient entry

  10. Time to opiate use for cancer-related pain

    number of participants

    Measured: 63 months after first patient entry

  11. Patient self-rate scale assessing the Quality of Life

    EQ5D-5L questionnaire asks respondents to simply 'mark an X on the scale to indicate how your health is TODAY' and then to 'write the number you marked on the scale in the box below'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.

    The respondent is asked to indicate his health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. It should be noted that the numerals 1-5 have no arithmetic properties and should not be used as a cardinal score.

    Measured: 46 and 63 months after first patient entry

  12. rate of skeletal fractures

    The rate of skeletal fractures per patient/year of follow-up will be estimated in each treatment arm using recurrent-event analysis methods. Analyses by type of fracture (e.g. pathological fracture) will also be conducted as appropriate.

    Measured: 63 months after first patient entry

Timeline

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

  1. First posted18 Jul 2014 (estimated)
  2. Study startOct 2015
  3. Primary completion19 Feb 2024
  4. Study completionDec 2028 (estimated)

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
None (open label)
Enrolment
446 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02194842
Sponsor's protocol ID
EORTC-1333-GUCG
Other IDs
2014-001787-36, 2014
Acronym
PEACE III
Status last verified
Sep 2025
First submitted
17 Jul 2014
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Tombal B, Saad F, Gallardo E, Soares A, Loriot Y, McDermott R, Briers E, Lagstrom M, Coens C, Poncet C, Fournier B, Gillessen S. A plain language summary of the EORTC 1333/PEACE-3 study of enzalutamide alone vs enzalutamide plus radium-223 in patients with metastatic castrationresistant prostate cancer (mCRPC) and bone metastases. Future Oncol. 2025 Dec;21(30):3845-3858. doi: 10.1080/14796694.2025.2592722. Epub 2025 Nov 28.

    PubMed 41313045

  • Gillessen S, Tombal B, Turco F, Choudhury A, Rodriguez-Vida A, Gallardo E, Velho PI, Nole F, Cruz F, Loriot Y, McDermott R, Roumeguere T, Daugaard G, Yamamura R, Bompas E, Maroto P, Polo MH, da Trindade KM, Preto DD, Skoneczna I, Lecouvet F, Coens C, Fournier B, Saad F. Decrease in Fracture Rate with Mandatory Bone-protecting Agents in the EORTC 1333/PEACE-3 Trial Comparing Radium-223 Combined with Enzalutamide Versus Enzalutamide Alone: A Safety Analysis. Eur Urol. 2025 Mar;87(3):285-288. doi: 10.1016/j.eururo.2024.11.027. Epub 2025 Jan 17.

    PubMed 39827019

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ra223 and Enzalutamide in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 64 sites in 12 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 68 inclusion and 31 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: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Brazil, Spain, Belgium, Canada, France and 7 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

radiological progression-free survival (time frame: 46 months after first patient entry). 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 NCT02194842, which also lists 2 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 19 Sep 2025.

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