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Scientists track how prostate cancer drug travels in bones

NCT ID NCT04521361

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at how the drug radium-223 spreads in the bones of men with prostate cancer that has spread to bones. Researchers gave the drug intravenously every 4 weeks for up to 6 doses and used imaging scans to measure its distribution in both tumor and healthy bone. The goal was to learn more about where the drug goes, not to test if it works.

What this could mean

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

Active substance
Radium-223 dichloride (Xofigo)
What this could lead to
If successful, this could help doctors better understand how radium-223 targets bone tumors, potentially improving future treatment plans for prostate cancer that has spread to bones.
What could go wrong
This is a small, early-phase study focused on measuring drug distribution, not on proving effectiveness. Results may not lead to direct treatment changes or benefits for participants.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

46 people

The number who actually took part.

Started

Nov 2020

Finished

Aug 2025

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: * Participants who have histologically confirmed adenocarcinoma of the prostate. * Participants with bone metastatic CRPC, progressing after 1 or 2 prior lines of systemic treatment for metastatic prostate cancer (including prior treatment for metastatic hormone sensitive prostate mHSPC or metastatic castration resistant prostate cancer mCRPC). * Participants with at least 2 bone metastases on Tc 99m phosphonate whole body planar bone scans at Screening. * Documented progression of mCRPC. Disease progression is defined by at least one of the following criteria: a. PCWG3 criteria (defined as 2 consecutive increases in PSA over a previous reference value measured at least one week prior, with a minimal start value of 1.0 ng/mL) or b. ≥2 new bone lesions (according to PCWG3 bone scan criteria) or c. Radiological progression according to RECIST, version 1.1. * Ability to participate in the required study procedures including all scanning procedures and ability to control pain to ensure tolerance and completion of the necessary scanning procedures. * Maintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7 nmol/L). If the participant is being treated with luteinizing hormone releasing hormone (LHRH) agonists or antagonists (participant who has not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to start of Screening and must be continued throughout the study. * Participants must be on a bone health agent prior to the first dose of radium-223 dichloride. Participants with at least 6 months of prior bone health agent (BHA) treatment are preferred. * Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1. * Life expectancy ≥6 months. Exclusion Criteria: * Any chronic medical condition requiring continuous systemic corticosteroid treatment at a higher dose than 5 mg prednisone / prednisolone twice daily. * Pathological finding consistent with neuroendocrine features small cell carcinoma of the prostate. * Metastatic bone deposits extend of disease (EOD) grades 0 or 4 (according to centrally assessed Tc 99m phosphonate planar bone scans during Screening). * History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations (according to central review at screening). * Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer). * Imminent spinal cord compression based on clinical findings and / or magnetic resonance imaging (MRI). - Participants with history of spinal cord compression should have completely recovered. * Active or symptomatic viral hepatitis * Inability to tolerate any of the other imaging procedures in the study (ie, bone SPECT/CT and planar bone scans with a Tc 99m phosphonate radiotracer, DXA scan, radium-223 SPECT/CT scans). * Any condition, which in the opinion of the investigator would preclude participation in this trial. * Hypersensitivity to radium-223 dichloride. * Blood transfusion or erythropoietin stimulating agents 4 weeks prior to start of Screening and during the whole Screening period before enrollment into the cohort. * Prior administration of an investigational therapeutic for CRPC.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale

    Reggio Emilia, Emilia-Romagna, 42123, Italy

  • Guy's and St. Thomas' NHS Trust, St. Thomas' Hospital

    London, SE1 7EH, United Kingdom

  • HCL - Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • ICM - Institut du Cancer de Montpellier - Val d'Aurelle

    Montpellier, 34298, France

  • Institut Claudius Regaud - iUCT Oncopole

    Toulouse, 31059, France

  • Institut de Cancerologie Ouest - Saint-Herblain

    Saint-Herblain, 44800, France

  • National Cancer Institute

    Vilnius, LT-08660, Lithuania

  • Rambam Health Corporation

    Haifa, 3109601, Israel

  • Royal Marsden NHS Trust (Surrey)

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Uniklinikum Salzburg - Landeskrankenhaus

    Salzburg, 5020, Austria

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG, United Kingdom

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, LT-08661, Lithuania