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Radioactive drug shows promise for Tough-to-Treat prostate cancer

NCT ID NCT00699751

Disease control Sponsor: Bayer 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a radioactive drug called radium-223 in 921 men with advanced prostate cancer that no longer responds to hormone therapy and has spread to the bones. The goal was to see if it helps them live longer and controls the cancer. Participants received either the drug or a placebo, and the study measured survival and side effects.

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

921 people

The number who actually took part.

Started

Jun 2008

Finished

Feb 2014

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Histologically or cytologically confirmed adenocarcinoma of the prostate * Known hormone refractory disease * Multiple skeletal metastases (≥ 2 hot spots) on bone scintigraphy * No intention to use cytotoxic chemotherapy within the next 6 months * Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with EBRT (External Beam Radiation Therapy) for bone pain Exclusion Criteria: * Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period * Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available * Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks ago * Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks * Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer) * History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks

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Conditions

The condition(s) this trial relates to.

hormone-resistant prostate carcinoma metastatic carcinoma in the bone

As listed by the trial registrant

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

Bone metastases Hormone refractory prostate cancer

Contacts and locations

Locations

  • Study site

    Los Angeles, California, 90048-0750, United States

  • Study site

    Roseville, California, 95661, United States

  • Study site

    Tampa, Florida, 33612-9416, United States

  • Study site

    New Orleans, Louisiana, 70112, United States

  • Study site

    St Louis, Missouri, 63110, United States

  • Study site

    Las Vegas, Nevada, 89169, United States

  • Study site

    Philadelphia, Pennsylvania, 19111-2497, United States

  • Study site

    Liverpool, New South Wales, 2170, Australia

  • Study site

    Randwick, New South Wales, 2031, Australia

  • Study site

    St Leonards, New South Wales, 2065, Australia

  • Study site

    Sydney, New South Wales, 2010, Australia

  • Study site

    Wahroonga, New South Wales, 2076, Australia

  • Study site

    Wollongong, New South Wales, 2521, Australia

  • Study site

    Herston, Queensland, 4006, Australia

  • Study site

    Toowoomba, Queensland, 4350, Australia

  • Study site

    Adelaide, South Australia, 5000, Australia

  • Study site

    Woodville South, South Australia, 5011, Australia

  • Study site

    Hobart, Tasmania, 7000, Australia

  • Study site

    Fitzroy, Victoria, 3065, Australia

  • Study site

    Nedlands, Western Australia, 6009, Australia

  • Study site

    Kortrijk, 8500, Belgium

  • Study site

    Ottignies, 1340, Belgium

  • Study site

    Salvador, Estado de Bahia, 41950-640, Brazil

  • Study site

    Belo Horizonte, Minas Gerais, 30110-090, Brazil

  • Study site

    Rio de Janeiro, Rio de Janeiro, 20551 030, Brazil

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Study site

    Barretos, São Paulo, 14784-400, Brazil

  • Study site

    Piracicaba, São Paulo, Brazil

  • Study site

    São Paulo, São Paulo, 05403-000, Brazil

  • Study site

    Belo Horizonte, 30380490, Brazil

  • Study site

    Edmonton, Alberta, T6G 1Z2, Canada

  • Study site

    London, Ontario, N6A 4G5, Canada

  • Study site

    Ottawa, Ontario, K1H 8L6, Canada

  • Study site

    Toronto, Ontario, M4N 3M5, Canada

  • Study site

    Brno, 65653, Czechia

  • Study site

    Chomutov, 430 12, Czechia

  • Study site

    Olomouc, 77900, Czechia

  • Study site

    Ostrava, 708 52, Czechia

  • Study site

    Plzen - Bory, 305 99, Czechia

  • Study site

    Prague, 140 59, Czechia

  • Study site

    Usti n/Labem, 401 13, Czechia

  • Study site

    La Roche-sur-Yon, 85925, France

  • Study site

    Montbéliard, 25209, France

  • Study site

    Saint-Cloud, 92210, France

  • Study site

    Ulm, Baden-Wurttemberg, 89075, Germany

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

  • Study site

    Frankfurt am Main, Hesse, 60590, Germany

  • Study site

    Marburg, Hesse, 35043, Germany

  • Study site

    Göttingen, Lower Saxony, 37075, Germany

  • Study site

    Hanover, Lower Saxony, 30625, Germany

  • Study site

    Dortmund, North Rhine-Westphalia, 44137, Germany

  • Study site

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Study site

    Berlin, State of Berlin, 10967, Germany

  • Study site

    Berlin, State of Berlin, 14197, Germany

  • Study site

    Chai Wan, Hong Kong

  • Study site

    Hong Kong, Hong Kong

  • Study site

    Kowloon, Hong Kong

  • Study site

    Beersheba, 8410101, Israel

  • Study site

    Kfar Saba, 4428164, Israel

  • Study site

    Tel Aviv, 6423906, Israel

  • Study site

    Zrifin, 7030000, Israel

  • Study site

    Forlì Cesena, Emilia-Romagna, 47014, Italy

  • Study site

    Reggio Emilia, Emilia-Romagna, 42123, Italy

  • Study site

    Bergamo, Lombardy, 24128, Italy

  • Study site

    Milan, Lombardy, 20162, Italy

  • Study site

    Turin, Piedmont, 10060, Italy

  • Study site

    Alkmaar, 1815 JD, Netherlands

  • Study site

    Nijmegen, 6532 SZ, Netherlands

  • Study site

    Rotterdam, 3015 CE, Netherlands

  • Study site

    Ålesund, TBC, Norway

  • Study site

    Bergen, 5021, Norway

  • Study site

    Bodø, 8092, Norway

  • Study site

    Kristiansand, N-4604, Norway

  • Study site

    Oslo, 0379, Norway

  • Study site

    Oslo, 450, Norway

  • Study site

    Tromsø, 9038, Norway

  • Study site

    Trondheim, 7030, Norway

  • Study site

    Bydgoszcz, 85-165, Poland

  • Study site

    Gliwice, 44-101, Poland

  • Study site

    Kielce, 25-734, Poland

  • Study site

    Krakow, 31-051, Poland

  • Study site

    Luiblin, 20-954, Poland

  • Study site

    Warsaw, 02-781, Poland

  • Study site

    Wroclaw, 50 - 556, Poland

  • Study site

    Wroclaw, 50-981, Poland

  • Study site

    Singapore, 258499, Singapore

  • Study site

    Singapore, 308433, Singapore

  • Study site

    Banská Bystrica, 97517, Slovakia

  • Study site

    Bratislava, 82606, Slovakia

  • Study site

    Bratislava, 83305, Slovakia

  • Study site

    Martin, 03659, Slovakia

  • Study site

    Prešov, 08181, Slovakia

  • Study site

    Trnava, 917 01, Slovakia

  • Study site

    Santiago de Compostela, A Coruña, 15706, Spain

  • Study site

    Barcelona, Barcelona, 08023, Spain

  • Study site

    Barcelona, Barcelona, 8036, Spain

  • Study site

    Barcelona, Barcelona, 8041, Spain

  • Study site

    Córdoba, Córdoba, 14004, Spain

  • Study site

    Alcorcón, Madrid, 28922, Spain

  • Study site

    Pamplona, Pamplona, 31008, Spain

  • Study site

    Valencia, Valencia, 46026, Spain

  • Study site

    Barakaldo, Vizcaya, 48903, Spain

  • Study site

    Zaragoza, Zaragoza, 50009, Spain

  • Study site

    Gothenburg, 413 45, Sweden

  • Study site

    Jönköping, 551 85, Sweden

  • Study site

    Kalmar, 391 85, Sweden

  • Study site

    Malmö, 205 02, Sweden

  • Study site

    Sandviken, 80187, Sweden

  • Study site

    Stockholm, 171 76, Sweden

  • Study site

    Sundsvall, 851 86, Sweden

  • Study site

    Umeå, 901 85, Sweden

  • Study site

    Bristol, Bristol, BS2 8ED, United Kingdom

  • Study site

    Romford, Essex, RM7 0AG, United Kingdom

  • Study site

    Leicester, Leicestershire, LE1 5WW, United Kingdom

  • Study site

    Manchester, Manchester, M20 4BX, United Kingdom

  • Study site

    Bebington, Merseyside, CH63 4JY, United Kingdom

  • Study site

    Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

  • Study site

    Taunton, Somerset, TA1 5DA, United Kingdom

  • Study site

    Ipswich, Suffolk, IP4 5PD, United Kingdom

  • Study site

    Guildford, Surrey, GU2 7XX, United Kingdom

  • Study site

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Study site

    Coventry, Warwickshire, CV2 2DX, United Kingdom

  • Study site

    Birmingham, West Midlands, B15 2TH, United Kingdom

  • Study site

    Belfast, BT9 7AB, United Kingdom

  • Study site

    Brighton, BN2 5BD, United Kingdom

  • Study site

    Cardiff, United Kingdom

  • Study site

    Derby, DE22 3NE, United Kingdom

  • Study site

    Hull, HU16 5JQ, United Kingdom

  • Study site

    Leeds, LS9 7TF, United Kingdom

  • Study site

    Northwood, HA6 2RN, United Kingdom

  • Study site

    Plymouth, PL6 8DH, United Kingdom

  • Study site

    Sheffield, S10 2SJ, United Kingdom

  • Study site

    Southampton, SO16 6YD, United Kingdom

  • Study site

    Wolverhampton, WV10 0QP, United Kingdom

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