Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE3
Total Enrollment
446 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-10-31
Study Completion Date
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Randomized Phase IIa Efficacy and Safety Study of Radium-223 Dichloride With Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (CRPC)
NCT02034552
Prostatic Neoplasms
COMPLETED
PHASE2
Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC
NCT04821622
Prostate Cancer
ACTIVE_NOT_RECRUITING
PHASE3
Trial of Rad-223 Activity in Asymptomatic Patients With mCRPC While on Abiraterone or Enzalutamide Besides AR-V7 Status
NCT03002220
Prostate Cancer
COMPLETED
PHASE2
Open Label Phase Two Study of Enzalutamide With Concurrent Administration of Radium Ra 223 Dichloride in Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Symptomatic Bone Metastasis
NCT02507570
Prostate Carcinoma Metastatic to the Bone
COMPLETED
PHASE2
Sequencing of Radium-223 and Docetaxel in Symptomatic Bone-only Metastatic Castration-resistant Prostate Cancer
NCT03230734
Metastatic Castration-resistant Prostate Cancer
ACTIVE_NOT_RECRUITING
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Prostate Cancer
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Enzalutamide
Enzalutamide will be given at a dose of 160 mg daily
Group Type
ACTIVE_COMPARATOR
Enzalutamide
Intervention Type
DRUG
Enzalutamide and Ra223
Ra223 will be administered 55kBq/kg standard dose monthly for 6 months and given in combination with enzalutamide at a dose of 160 mg daily.
Group Type
EXPERIMENTAL
Ra223
Intervention Type
DRUG
Enzalutamide
Intervention Type
DRUG
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ra223
Intervention Type
DRUG
Enzalutamide
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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
* 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.
* 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
Exclusion Criteria
* No known history of central nervous system metastases or leptomeningeal tumor spread.
* No significant cardiovascular disease including:
1. Myocardial infarction within 6 months prior to screening
2. Uncontrolled angina within 3 months prior to screening
3. 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%
4. History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)
5. History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
6. Uncontrolled hypertension as indicated by a resting systolic blood pressure \> 170 mm Hg or diastolic blood pressure \> 105 mm Hg at screening
7. Hypotension as indicated by systolic blood pressure \< 86 millimeters of mercury (mm Hg) at screening
8. 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:
1. Any infection ≥ Grade 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4
2. No gastrointestinal disorder affecting absorption (e.g., gastrectomy or active peptic ulcer disease)
3. Crohn's disease or ulcerative colitis
4. Bone marrow dysplasia
5. Fecal incontinence
6. Life-threatening illness unrelated to cancer
* No condition which, in the investigator's opinion, makes the patient unsuitable for trial participation
* No significant cardiovascular disease including:
1. Myocardial infarction within 6 months prior to screening
2. Uncontrolled angina within 3 months prior to screening
3. 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%
4. History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)
5. History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
6. Uncontrolled hypertension as indicated by a resting systolic blood pressure \> 170 mm Hg or diastolic blood pressure \> 105 mm Hg at screening
7. Hypotension as indicated by systolic blood pressure \< 86 millimeters of mercury (mm Hg) at screening
8. 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:
1. Any infection ≥ Grade 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4
2. No gastrointestinal disorder affecting absorption (e.g., gastrectomy or active peptic ulcer disease)
3. Crohn's disease or ulcerative colitis
4. Bone marrow dysplasia
5. Fecal incontinence
6. Life-threatening illness unrelated to cancer
* No condition which, in the investigator's opinion, makes the patient unsuitable for trial participation
Minimum Eligible Age
18 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Sponsor Role
collaborator
Astellas Pharma Europe Ltd.
INDUSTRY
Sponsor Role
collaborator
UNICANCER
OTHER
Sponsor Role
collaborator
Canadian Urologic Oncology Group
OTHER
Sponsor Role
collaborator
Latin American Cooperative Oncology Group
OTHER
Sponsor Role
collaborator
Cancer Trials Ireland
NETWORK
Sponsor Role
collaborator
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bertrand Tombal, Prof
Role: STUDY_CHAIR
Cliniques Universitaires de Saint Luc
Silke Gillessen, Prof
Role: STUDY_CHAIR
Oncology Institute of Southern Switzerland - Ospedale San Giovanni
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hopital Universitaire Brugmann
Brussels, , Belgium
Site Status
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme
Brussels, , Belgium
Site Status
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Site Status
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Site Status
AZ Groeninge Kortrijk
Kortrijk, , Belgium
Site Status
U.Z. Leuven - Campus Gasthuisberg
Leuven, , Belgium
Site Status
AZ Turnhout
Turnhout, , Belgium
Site Status
CHU Dinant Godinne - UCL Namur
Yvoir, , Belgium
Site Status
Hospital de Amor
Barretos, , Brazil
Site Status
Hospital Erasto Gaertner
Curitiba, , Brazil
Site Status
Centro Pesquisas Oncologicas
Florianópolis, , Brazil
Site Status
Oncocentro
Fortaleza, , Brazil
Site Status
Hospital Moinhos de Vento
Porto Alegre, , Brazil
Site Status
Centro de Pesquisas Clinicas em Oncologia - Hospital Sao Lucas
Porto Alegre, , Brazil
Site Status
Instituto de Medicina Integral Professor Fernando Figueira - IMIP
Recife, , Brazil
Site Status
Centro de Tratamentos de Tumores Botafogo
Rio de Janeiro, , Brazil
Site Status
Clínica Oncológica - CLION
Salvador, , Brazil
Site Status
Centro de Estudos e Pesquisa Hematologia e Oncologia
Santo André, , Brazil
Site Status
Hospital Beneficencia Portuguesa
São Paulo, , Brazil
Site Status
Hospital Paulistano
São Paulo, , Brazil
Site Status
Sao Camilo Oncologia - Instituto Brasileiro de Controle do Cancer
São Paulo, , Brazil
Site Status
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Site Status
Hamilton And District Urology Association
Hamilton, Ontario, Canada
Site Status
London Regional Cancer Center
London, Ontario, Canada
Site Status
Odette Cancer Centre - Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Site Status
University Health Network - Oci Princess Margaret Hospital
Toronto, Ontario, Canada
Site Status
Centre de sante et de services sociaux de Chicoutimi
Chicoutimi, Quebec, Canada
Site Status
CHUM - Centre Hospitalier de l'Université de Montreal - Pavillon Saint-Luc
Montreal, Quebec, Canada
Site Status
Chuq-Pavillon Hotel-Dieu De Quebec
Québec, Quebec, Canada
Site Status
Rigshospitalet
Copenhagen, , Denmark
Site Status
Institut de Cancerologie de l'Ouest (ICO) - Centre Paul Papin
Angers, , France
Site Status
Centre Francois Baclesse
Caen, , France
Site Status
Assistance Publique - Hopitaux de Paris - CHU Henri Mondor
Créteil, , France
Site Status
Centre Leon Berard
Lyon, , France
Site Status
Institut régional du Cancer Montpellier
Montpellier, , France
Site Status
Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau
Saint-Herblain, , France
Site Status
Hopitaux Universitaires de Strasbourg - Hôpitaux Universitaires de Strasbourg - Hôpital civil
Strasbourg, , France
Site Status
Gustave Roussy
Villejuif, , France
Site Status
Cork University Hospital
Cork, , Ireland
Site Status
St. Vincent's University Hospital
Dublin, , Ireland
Site Status
Tallaght University Hospital
Dublin, , Ireland
Site Status
Ospedale B.Ramazzini
Carpi, , Italy
Site Status
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, , Italy
Site Status
Istituto Europeo di Oncologia
Milan, , Italy
Site Status
Soerlandet Sykehus-Kristiansand
Kristiansand, , Norway
Site Status
University Hospital of North Norway
Tromsø, , Norway
Site Status
Maria Sklodowska-Curie Memorial Cancer Centre
Warsaw, , Poland
Site Status
Hospital Del Mar
Barcelona, , Spain
Site Status
Vall d'Hebron Institut d'Oncologia
Barcelona, , Spain
Site Status
Hospital Clinic Universitari de Barcelona
Barcelona, , Spain
Site Status
Hospital De La Santa Creu I Sant Pau
Barcelona, , Spain
Site Status
Hospital Universitario de La Princesa
Madrid, , Spain
Site Status
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Site Status
Hospital Universitario QuironSalud
Madrid, , Spain
Site Status
Complejo Hospitalario de Navarra
Pamplona, , Spain
Site Status
Corporacio Sanitaria Parc Tauli
Sabadell, , Spain
Site Status
Hospital Universitario de Salamanca
Salamanca, , Spain
Site Status
Oncology Institute of Southern Switzerland - Ospedale San Giovanni
Bellinzona, , Switzerland
Site Status
Kantonsspital St Gallen
Sankt Gallen, , Switzerland
Site Status
UniversitaetsSpital Zurich
Zurich, , Switzerland
Site Status
United Lincolnshire Hospitals NHS Trust - Lincoln County Hospital
Lincoln, , United Kingdom
Site Status
Royal Marsden Hospital - Chelsea, London
London, , United Kingdom
Site Status
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Site Status
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, , United Kingdom
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Belgium
Brazil
Canada
Denmark
France
Ireland
Italy
Norway
Poland
Spain
Switzerland
United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-001787-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EORTC-1333-GUCG
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Phase I Trial of PACE for Metastatic Prostate Cancer
NCT03110588
WITHDRAWN
PHASE1
Enzalutamide With or Without Radium Ra 223 Dichloride in Patients With Metastatic, Castration-Resistant Prostate Cancer
NCT03344211
ACTIVE_NOT_RECRUITING
PHASE2
A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
NCT02960022
RECRUITING
PHASE2
Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate
NCT02268175
COMPLETED
PHASE2
Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer
NCT02003924
ACTIVE_NOT_RECRUITING
PHASE3
BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC)
NCT02204072
COMPLETED
PHASE1
Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer
NCT01949337
UNKNOWN
PHASE3
The Combination Therapy With Ra-223 and Enzalutamide
NCT03305224
UNKNOWN
PHASE2
Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With mCSPC
NCT05771896
WITHDRAWN
PHASE3
A Placebo-controlled Phase II Study of Bone-targeted Radium-223 in Symptomatic Hormone-refractory Prostate Cancer
NCT00459654
COMPLETED
PHASE2
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
NCT03395197
ACTIVE_NOT_RECRUITING
PHASE3
Radium-223 in Combination With Enzalutamide
NCT02225704
COMPLETED
PHASE2
Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer
NCT01664923
COMPLETED
PHASE2
A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
NCT02677896
COMPLETED
PHASE3
Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer
NCT02023463
ACTIVE_NOT_RECRUITING
PHASE1
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
NCT03767244
ACTIVE_NOT_RECRUITING
PHASE3
Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer
NCT03360721
ACTIVE_NOT_RECRUITING
PHASE2
ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
NCT04986423
RECRUITING
PHASE2
177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer
NCT05204927
ACTIVE_NOT_RECRUITING
PHASE3
Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC
NCT02913196
ACTIVE_NOT_RECRUITING
PHASE1
Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer
NCT03072238
COMPLETED
PHASE3
Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer
NCT02685267
TERMINATED
PHASE2
Prostate Cancer Intensive, Non-Cross Reactive Therapy (PRINT) for Castration Resistant Prostate Cancer (CRPC)
NCT02903160
COMPLETED
PHASE2
Phase I/II Study of ASP9521 in Castrate-Resistant Prostate Cancer (CRPC) Patients
NCT01352208
TERMINATED
PHASE1/PHASE2