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A Study to Assess How Radium-223 Distributes in the Body of Patients With Prostate Cancer Which Spread to the Bones

NCT04521361

Description:

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 study plans to enroll 60 patients with the age of at least 18 years and suffering from prostate cancer which has spread to the bones. Researcher will divide the study participants into 2 groups. Patients in Group 1 should have up to 6 bone metastases and patients for group 2 should have more than 6 bone metastases. The study medication will be given as injection into a vein every 4 weeks up to a maximum of 6 times. To study how radium distributes in the body and particularly in the bones, participants will undergo after study medication intake MRI or CT Scans (imaging techniques).

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study to Assess How Radium-223 Distributes in the Body of Patients With Prostate Cancer Which Spread to the Bones
  • Official Title: Open-label, Non-randomized Phase 1, Multicenter Study to Assess Radium- 223 Biodistribution in Participants With Bone Metastatic Castration Resistant Prostate Cancer (CRPC) Receiving Radium-223 Dichloride Treatment.

Clinical Trial IDs

  • ORG STUDY ID: 20511
  • SECONDARY ID: 2019-000475-17
  • NCT ID: NCT04521361

Conditions

  • Bone Metastatic Castration-resistant Prostate Cancer

Interventions

DrugSynonymsArms
Radium-223 dichloride (Xofigo, BAY88-8223)Patients with High extent of disease

Purpose

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 study plans to enroll 60 patients with the age of at least 18 years and suffering from prostate cancer which has spread to the bones. Researcher will divide the study participants into 2 groups. Patients in Group 1 should have up to 6 bone metastases and patients for group 2 should have more than 6 bone metastases. The study medication will be given as injection into a vein every 4 weeks up to a maximum of 6 times. To study how radium distributes in the body and particularly in the bones, participants will undergo after study medication intake MRI or CT Scans (imaging techniques).

Trial Arms

NameTypeDescriptionInterventions
Patients with Low extent of diseaseExperimentalAdult men with bone mCRPC having < 6 bone metastases
  • Radium-223 dichloride (Xofigo, BAY88-8223)
Patients with High extent of diseaseExperimentalAdult men with bone mCRPC having ≥ 6 bone metastases
  • Radium-223 dichloride (Xofigo, BAY88-8223)

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:AUC of radium-223 in tumor-free bone after 3 doses
Time Frame:At 4, 24 and 144 hours post injection at Cycle 3 ( total duration of one cycle is 28 days).
Safety Issue:
Description:The uptake of radium-223 in bone is determined with single-photon emission tomography / computed tomography (SPECT/CT).

Secondary Outcome Measures

Measure:AUC of radium-223 in tumor-free bone after single dose
Time Frame:At 4, 24 and 144 hours post injection at Cycle 1 ( total duration of one cycle is 28 days).
Safety Issue:
Description:
Measure:AUC of radium-223 in tumor-free bone after 6 doses
Time Frame:At 4, 24 and 144 hours post injection at Cycle 6 ( total duration of one cycle is 28 days).
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bayer

Trial Keywords

  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Single-photon emission tomography / computed tomography (SPECT/CT)
  • radium-223,
  • phase I

Last Updated

August 18, 2020