AzTrials
AzTrials

Prostate CancerPhase 3NCT03574571

A Study to Test Radium-223 With Docetaxel in Patients With Prostate Cancer

A Phase 3 study testing Docetaxel 75 mg/m2, Docetaxel 60 mg/m2 and Radium-223 in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 72 sites in 4 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

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. 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?
Docetaxel 75 mg/m2, Docetaxel 60 mg/m2 and Radium-223
Could I receive a placebo?
No, everyone receives an active treatment
How many people
732 participants
Where
72 sitesin 4 countries
Study dates
19 Jun 2018to 1 Apr 2027
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

  • Willing and able to provide written informed consent (ICF) and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
  • NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
  • Males 18 years of age and above
  • Histological or cytological proof of prostate cancer
  • Documented progressive mCRPC based on at least one of the following criteria:
  • 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.
Show all 24Show fewer
  • 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.
  • 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

Who cannot join

  • 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 pcctc@mskcc.org 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 pcctc@mskcc.org 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.
Show all 24Show fewer
  • 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

Trial locations and contacts

72 sites in 4 countries.

72 sites in 4 countries

United States40 sites

  • New Mexico Oncology and Hematology

    Albuquerque, New Mexico, 87109

  • University of Michigan Cancer Center

    Ann Arbor, Michigan, 48109

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • University of Buffalo

    Buffalo, New York, 14203

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • MD Anderson Cancer Center at Cooper

    Camden, New Jersey, 08103

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Rush University Medical Center

    Chicago, Illinois, 606012

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Houston Methodist Research Institute

    Houston, Texas, 77030

  • Millennium Physicians

    Houston, Texas, 77090

  • Indiana University

    Indianapolis, Indiana, 46202

  • Dayton Physicians Network

    Kettering, Ohio, 45409

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128

  • Mount Sinai Medical Center (Miami)

    Miami, Florida, 33140

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Atrium Health/ Levine Cancer Institute

    Monroe, North Carolina, 28112

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • Yale University- Yale Cancer Center

    New Haven, Connecticut, 06510

  • Ochsner Cancer Institute

    New Orleans, Louisiana, 70121

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • New York Presbyterian Hospital-Weill Medical College of Cornell University

    New York, New York, 10065

  • Bronx VA Hospital

    New York, New York, 10468

  • Helen Graham Cancer Center (Christiana Care)

    Newark, Delaware, 19713

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68114

  • XCancer Omaha / Urology Cancer Center

    Omaha, Nebraska, 68130

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • New Jersey Urology

    Saddle Brook, New Jersey, 07663

  • University of Washington

    Seattle, Washington, 98109

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

  • University of Massachusetts

    Worcester, Massachusetts, 01655

Other trials in United States

Netherlands13 sites

  • Noordwest Ziekenhuisgrouep Alkmaar (NWZ)

    Alkmaar, 1815

  • Ziekenhuisgroep Twente (ZGT)

    Almelo, 7609

  • Nederlands Kanker Instituut

    Amsterdam, Plesmanlaan, 1066 CX

  • Amphia Hospital

    Breda, 4818

  • Deventer Ziekenhuis

    Deventer

  • Tergooi Hospital

    Hilversum, 1213

  • Canisius Wilhelmina Ziekenhuis (CWZ)

    Nijmegen, 6532

  • Erasmus MC Cancer Institute

    Rotterdam, 3015 GD

  • Franciscus Gasthuis & Vlietland

    Rotterdam, 3045

  • Maasstad Hospital

    Rotterdam, 3079

  • Haaglanden Medical Center

    The Hague, 2512

  • St. Antonius Ziekenhuis (Utrecht)

    Utrecht

  • Isala Kliniek

    Zwolle, 8025

Other trials in Netherlands

Brazil10 sites

  • Hospital de Amor de Barretos (Fundação Pio XII) / Barretos Cancer Hospital

    Barretos, Dr. Paulo Prata, 14784-400

  • Instituto de Medicina Integral Professor Fernando Figueira (IMIP)

    Boa Vista, Pernambuco, 50.070-902

  • Hospital Sírio Libanês

    Brasília, 70200-730

  • Hospital Erasto Gaertner

    Curitiba

  • CPORS - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS

    Porto Alegre, 90610000

  • Hospital Moinhos de Vento (HMV)

    Porto Alegre

  • Instituto Brasileiro de Controle do Câncer/IBCC

    São Paulo, State of São Paulo

  • Hospital Israelita Albert Einstein

    São Paulo, 05652-900

  • Beneficência Portuguesa

    São Paulo

  • Centro de Pesquisas São Lucas - Sociedade Campineira de Educação e Instrução (SCEI)

    São Paulo

Other trials in Brazil

Spain9 sites

  • Hospital Del Mar

    Barcelona, 08003

  • Vall d'Hebron Institute of Oncology (VHIO)

    Barcelona, 08035

  • Clinic de Barcelona

    Barcelona, 08036

  • Hospital Provincial de Castellón

    Castellon, 12006

  • Ramón y Cajal Hospital

    Madrid, Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Central de Asturias (HUCA)

    Oviedo, Avenida de Roma S/n, 33011

  • Hospital Universitario Virgen Del Rocío

    Seville

  • Instituto Valenciano de Oncología

    Valencia

Other trials in Spain

About this study

Official title: Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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.

Conditions
Prostate Cancer
Being tested
Docetaxel 75 mg/m2, Docetaxel 60 mg/m2, Radium-223
Keywords
Radium-223, Docetaxel, 18-150, C16-174, DORA Trial
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Docetaxel 75 mg/m2Drug

    Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses.

  • Docetaxel 60 mg/m2Drug

    Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses.

  • Radium-223Drug

    Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.

Study groups in NCT03574571
Study groupRoleWhat they receive
DocetaxelExperimentalDocetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses. Prednisone will be given at a dose of 5mg orally twice daily.
Receives: Drug: Docetaxel 75 mg/m2
Docetaxel with Radium-223ExperimentalDocetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses. Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.
Receives: Drug: Docetaxel 60 mg/m2; Drug: Radium-223

What is being measured

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

  1. Overall survival

    Overall survival is defined as the time from randomization to death from any cause.

    Measured: 2 years

Timeline

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

  1. First posted2 Jul 2018
  2. Study start19 Jun 2018
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2027 (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
Model description
This is an open-labeled, randomized, phase III study of docetaxel versus docetaxel in combination with radium-223 in subjects with mCRPC.
Masking
None (open label)
Enrolment
732 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03574571
Sponsor's protocol ID
18-150
Other IDs
2018-002944-10, 2018
Status last verified
May 2026
First submitted
20 Jun 2018
Last updated
14 May 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel 75 mg/m2, Docetaxel 60 mg/m2 and Radium-223 in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 72 sites in 4 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 24 inclusion and 24 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Netherlands, Brazil, Spain. 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?

Overall survival (time frame: 2 years). 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 NCT03574571.

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 14 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in