NCT03574571Active, not recruitingPhase 3
A Study to Test Radium-223 With Docetaxel in Patients With Prostate Cancer
Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone. Earlier studies helped show that the combination is safe, but the combination has not been proven to work better than either drug alone. The goal of this study is to find out if combining docetaxel and radium-223 is better than giving either drug by itself.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 732 (actual)
- First submitted
- 20 Jun 2018
- Start date
- 19 Jun 2018
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT03574571
- EU CT number
- 2024-513867-19-00
- EudraCT number
- 2018-002944-10
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 732
- From 19 Jun 2018 to the primary completion date, 1 Apr 2027
- 74 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Histological or cytological proof of prostate cancer
- Documented progressive mCRPC based on at least one of the following criteria: 1. PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 1.0 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 1.0 ng/mL. 2. Soft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions. 3. Progression of bone disease (evaluable disease) or two or more new bone lesions by bone scan.
- Two or more bone lesions
- ECOG 0- 1
- Normal organ function with acceptable initial laboratory values within 14 days of randomization: * Albumin \> 30 g/L * ANC ≥ 1.5 x 10\^9/L * Hemoglobin ≥ 10 g/dL * Platelet count ≥ 100 x 10\^9/L * Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN) * Bilirubin ≤ ULN (unless documented Gilbert's disease) * SGOT (AST) ≤ 1.5 x ULN * SGPT (ALT) ≤ 1.5 x ULN * WBC count ≥ 3 x 10\^9/L
- Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug. Sperm donation is prohibited during the study and for 30 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.
- Serum testosterone \< 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy.
- All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less.
- Willing and able to comply with the protocol, including follow-up visits and examinations Exclusion Criteria: * Received any other investigational therapeutic agents or other anticancer therapies within 4 weeks prior to randomization. °Note: If this requirement to have a washout of 2 weeks or 5 half-lives prior to randomization causes potential treatment delay due to Radium-223 importation timelines, the PCCTC must be contacted at to request approval to randomize the subject prior to the completion of the washout. Requests for early randomization must be accompanied by written assurance by the site that the washout will be completed prior to treatment start.
- Received external beam radiotherapy within the 4 weeks prior to randomization. ° Note: If prolonging randomization to complete EBRT washout causes potential treatment delay due to Radium-223 importation timelines, the PCCTC must be contacted at to request approval to randomize the subject prior to the completion of the washout. Requests for early randomization must be accompanied by written assurance by the site that the washout will be completed prior to treatment start.
- Has an immediate need for external beam radiotherapy.
- Has received any systemic bone-seeking radiopharmaceutical in the past.
- Has received any prostate cancer directed chemotherapy in the castration resistant setting. Subjects who have received up to 6 prior doses of docetaxel in the castration sensitive setting are permitted if they have not experienced disease progression within 36 weeks of last treatment with docetaxel.
- Has received four or more systemic anticancer regimens for mCRPC. * Treatment with docetaxel or abiraterone for non-castrate metastatic disease is permissible and does not count towards the lines of therapy for mCRPC * A 'line' is a regimen. Combinations of hormones and other types of therapies count as single lines.
- Has known Grade ≥3 docetaxel-related toxicities or docetaxel toxicity related dose interruption or discontinuation.
- Has received blood transfusions or growth factors within the last 4 weeks prior to randomization.
- Symptomatic nodal disease (i.e., scrotal, penile, or leg edema).
- Has visceral metastases with ≥ 3 lung and/or liver metastases or individual lesion ≥2 cm, as assessed by CT scan or MRI of the chest/abdomen/pelvis within the last 8 weeks prior to randomization.
- Symptomatic loco-regional disease that causes ongoing Grade 3 or Grade 4 urinary or rectal symptoms.
- Subjects with a "currently active" second malignancy other than non-melanoma skin cancers or non-invasive bladder cancers or other in-situ or non-invasive malignancies. Subjects are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
- Has imminent or established cord compression based on clinical findings and/or MRI.
- Known bone marrow dysplasia
- Has received any of the following in the 4 weeks prior to randomization: 5-alpha-reductase inhibitors, herbal medications, natural hormonally active foods (e.g., phytoestrogens) or other food supplements known to alter PSA in humans
- Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including but not limited to: * Uncontrolled infection * NYHA III or IV heart failure * Crohn's disease or those with ulcerative colitis who have not undergone a colectomy * Known active infection with HIV, Hepatitis B or Hepatitis C
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (74)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Amor de Barretos (Fundação Pio XII) / Barretos Cancer Hospital Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Instituto de Medicina Integral Professor Fernando Figueira (IMIP) Coordinator of this site? Confirm its status | Boa Vista | Brazil | Unknown status |
| Hospital Sírio-Libanês Coordinator of this site? Confirm its status | Brasília | Brazil | Unknown status |
| Hospital Erasto Gaertner Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Hospital Moinhos de Vento (HMV) Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| CPORS - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Instituto Brasileiro de Controle do Cancer Ibcc Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Centro de Pesquisas São Lucas - Sociedade Campineira de Educação e Instrução (SCEI) Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Beneficência Portuguesa Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital Israelita Albert Einstein Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Consorcio Hospitalario Provincial De Castellon Coordinator of this site? Confirm its status | Castello De La Plana | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Active, not recruiting |
| Hospital Quironsalud Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Noordwest Ziekenhuisgroep Stichting Coordinator of this site? Confirm its status | Alkmaar | Netherlands | Active, not recruiting |
| Ziekenhuisgroep Twente Stichting Coordinator of this site? Confirm its status | Almelo | Netherlands | Active, not recruiting |
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Active, not recruiting |
| Amphia Hospital Coordinator of this site? Confirm its status | Breda | Netherlands | Active, not recruiting |
| Deventer Ziekenhuis Coordinator of this site? Confirm its status | Deventer | Netherlands | Active, not recruiting |
| Tergooiziekenhuizen Coordinator of this site? Confirm its status | Hilversum | Netherlands | Active, not recruiting |
| Medical Center Haaglanden Coordinator of this site? Confirm its status | Leidschendam | Netherlands | Active, not recruiting |
| Sint Antonius Ziekenhuis Stichting Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Active, not recruiting |
| Canisius Wilhelmina Ziekenhuis Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Active, not recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Active, not recruiting |
| Maasstad Ziekenhuis Stichting Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Active, not recruiting |
| Sint Franciscus Vlietland Groep Stichting Coordinator of this site? Confirm its status | Schiedam | Netherlands | Active, not recruiting |
| Isala Klinieken Stichting Coordinator of this site? Confirm its status | Zwolle | Netherlands | Active, not recruiting |
| New Mexico Oncology and Hematology Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| University of Michigan Cancer Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| MidLantic Urology Coordinator of this site? Confirm its status | Bala-Cynwyd | United States | Unknown status |
| University of Maryland Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Memorial Sloan Kettering Basking Ridge Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Boca Raton Regional Hospital Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| University of Buffalo Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| MD Anderson Cancer Center at Cooper Coordinator of this site? Confirm its status | Camden | United States | Unknown status |
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Cincinnati Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Memorial Sloan Kettering Commack Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Banner MD Anderson Cancer Center Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| Memorial Sloan Kettering Westchester Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Houston Methodist Research Institute Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Millennium Physicians Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Dayton Physicians Network Coordinator of this site? Confirm its status | Kettering | United States | Unknown status |
| Comprehensive Cancer Centers of Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Mount Sinai Medical Center (Miami) Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Memorial Sloan Kettering Monmouth Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Atrium Health/ Levine Cancer Institute Coordinator of this site? Confirm its status | Monroe | United States | Unknown status |
| Memorial Sloan Kettering Bergen Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Helen Graham Cancer Center (Christiana Care) Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Yale University, Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Ochsner Cancer Institute Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| New York Presbyterian Hospital-Weill Medical College of Cornell University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Bronx VA Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Oklahoma Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Nebraska Cancer Specialists Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| XCancer Omaha / Urology Cancer Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| New Jersey Urology Coordinator of this site? Confirm its status | Saddle Brook | United States | Unknown status |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Memorial Sloan Kettering Nassau Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
| University of Massachusetts Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.