Status:
COMPLETED
A Study to Assess How Radium-223 Distributes in the Body of Patients With Prostate Cancer Which Spread to the Bones
Lead Sponsor:
Bayer
Conditions:
Bone Metastatic Castration-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
In this study researcher want to gain more information on how the study drug (radium-223) is distributed in the bone, particularly in the tumor free bone in participants with prostate cancer. The stud...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04521361
Start Date
November 16 2020
End Date
August 27 2025
Last Update
September 19 2025
Active Locations (12)
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1
Uniklinikum Salzburg - Landeskrankenhaus
Salzburg, Austria, 5020
2
ICM - Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, France, 34298
3
HCL - Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495
4
Institut de Cancerologie Ouest - Saint-Herblain
Saint-Herblain, France, 44800