Cure My Disease

Don't miss your cure!

 Log in / Sign up

Double-Drug attack on advanced prostate cancer put to the test

NCT ID NCT03574571

Disease control Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial compares the standard chemotherapy docetaxel alone versus docetaxel plus radium-223 in 732 men with metastatic castration-resistant prostate cancer that has spread and stopped responding to hormone therapy. The goal is to see if adding radium-223 helps patients live longer. Earlier studies showed the combination is safe, but it is not yet proven to work better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
docetaxel and radium-223
What this could lead to
If successful, this combination could become a new standard treatment to help men with advanced prostate cancer live longer.
What could go wrong
This is a late-stage trial, but the combination may not prove better than docetaxel alone. Side effects from both drugs can be serious, including bone marrow suppression and fatigue.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

732 people

The number who actually took part.

Started

Jun 2018

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 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 [email protected] 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 [email protected] 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Metastatic castration-resistant prostate cancer are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • Amphia Hospital

    Breda, 4818, Netherlands

  • Atrium Health/ Levine Cancer Institute

    Monroe, North Carolina, 28112, United States

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Beneficência Portuguesa

    São Paulo, Brazil

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486, United States

  • Bronx VA Hospital

    New York, New York, 10468, United States

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

    Porto Alegre, 90610000, Brazil

  • Canisius Wilhelmina Ziekenhuis (CWZ)

    Nijmegen, 6532, Netherlands

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

    São Paulo, Brazil

  • Clinic de Barcelona

    Barcelona, 08036, Spain

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128, United States

  • Dayton Physicians Network

    Kettering, Ohio, 45409, United States

  • Deventer Ziekenhuis

    Deventer, Netherlands

  • Erasmus MC Cancer Institute

    Rotterdam, 3015 GD, Netherlands

  • Franciscus Gasthuis & Vlietland

    Rotterdam, 3045, Netherlands

  • Haaglanden Medical Center

    The Hague, 2512, Netherlands

  • Helen Graham Cancer Center (Christiana Care)

    Newark, Delaware, 19713, United States

  • Hospital Del Mar

    Barcelona, 08003, Spain

  • Hospital Erasto Gaertner

    Curitiba, Brazil

  • Hospital Israelita Albert Einstein

    São Paulo, 05652-900, Brazil

  • Hospital Moinhos de Vento (HMV)

    Porto Alegre, Brazil

  • Hospital Provincial de Castellón

    Castellon, 12006, Spain

  • Hospital Sírio Libanês

    Brasília, 70200-730, Brazil

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Central de Asturias (HUCA)

    Oviedo, Avenida de Roma S/n, 33011, Spain

  • Hospital Universitario Virgen Del Rocío

    Seville, Spain

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

    Barretos, Dr. Paulo Prata, 14784-400, Brazil

  • Houston Methodist Research Institute

    Houston, Texas, 77030, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Instituto Brasileiro de Controle do Câncer/IBCC

    São Paulo, State of São Paulo, Brazil

  • Instituto Valenciano de Oncología

    Valencia, Spain

  • Instituto de Medicina Integral Professor Fernando Figueira (IMIP)

    Boa Vista, Pernambuco, 50.070-902, Brazil

  • Isala Kliniek

    Zwolle, 8025, Netherlands

  • MD Anderson Cancer Center at Cooper

    Camden, New Jersey, 08103, United States

  • Maasstad Hospital

    Rotterdam, 3079, Netherlands

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Millennium Physicians

    Houston, Texas, 77090, United States

  • Mount Sinai Medical Center (Miami)

    Miami, Florida, 33140, United States

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68114, United States

  • Nederlands Kanker Instituut

    Amsterdam, Plesmanlaan, 1066 CX, Netherlands

  • New Jersey Urology

    Saddle Brook, New Jersey, 07663, United States

  • New Mexico Oncology and Hematology

    Albuquerque, New Mexico, 87109, United States

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

    New York, New York, 10065, United States

  • Noordwest Ziekenhuisgrouep Alkmaar (NWZ)

    Alkmaar, 1815, Netherlands

  • Ochsner Cancer Institute

    New Orleans, Louisiana, 70121, United States

  • Ramón y Cajal Hospital

    Madrid, Madrid, 28034, Spain

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001, United States

  • Rush University Medical Center

    Chicago, Illinois, 606012, United States

  • St. Antonius Ziekenhuis (Utrecht)

    Utrecht, Netherlands

  • Tergooi Hospital

    Hilversum, 1213, Netherlands

  • University of Buffalo

    Buffalo, New York, 14203, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Massachusetts

    Worcester, Massachusetts, 01655, United States

  • University of Michigan Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27514, United States

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Washington

    Seattle, Washington, 98109, United States

  • Vall d'Hebron Institute of Oncology (VHIO)

    Barcelona, 08035, Spain

  • XCancer Omaha / Urology Cancer Center

    Omaha, Nebraska, 68130, United States

  • Yale University- Yale Cancer Center

    New Haven, Connecticut, 06510, United States

  • Ziekenhuisgroep Twente (ZGT)

    Almelo, 7609, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.