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

Bone Metastatic Castration-resistant Prostate Cancer Clinical Trial

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04521361
• Other study ID #: 20511
• Secondary ID: 2023-506435-15-0
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 16, 2020
• Est. completion date: September 1, 2025

Study information

• Verified date: June 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: September 1, 2025
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Radium-223 dichloride (Xofigo, BAY88-8223)
Drug will be administered as aqueous solution intravenously at a dose of 55 kBq/kg body weight every 4 weeks for 6 cycles (cycle length = 4 weeks).

Locations

Country	Name	City	State
Austria	Uniklinikum Salzburg - Landeskrankenhaus	Salzburg
France	Institut du Cancer de Montpellier - Val d'Aurelle	Montpellier Cedex
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	Institut de Cancérologie de l'Ouest - Saint Herblain	Saint-Herblain
France	Institut Claudius Regaud - iUCT Oncopole	Toulouse Cedex 9
Israel	Rambam Health Corporation	Haifa
Italy	AUSL-IRCCS di Reggio Emilia	Reggio Emilia	Emilia-Romagna
Lithuania	National Cancer Institute	Vilnius
Lithuania	Vilnius University Hospital Santaros Klinikos	Vilnius
United Kingdom	Guy's and St. Thomas' NHS Trust, St. Thomas' Hospital	London
United Kingdom	University College London Hospitals NHS Foundation Trust	London
United Kingdom	Royal Marsden NHS Trust (Surrey)	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  France,  Israel,  Italy,  Lithuania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of radium-223 in tumor-free bone after 3 doses	The uptake of radium-223 in bone is determined with single-photon emission tomography / computed tomography (SPECT/CT).	At 4, 24 and 144 hours post injection at Cycle 3 ( total duration of one cycle is 28 days).
Secondary	AUC of radium-223 in tumor-free bone after single dose		At 4, 24 and 144 hours post injection at Cycle 1 ( total duration of one cycle is 28 days).
Secondary	AUC of radium-223 in tumor-free bone after 6 doses		At 4, 24 and 144 hours post injection at Cycle 6 ( total duration of one cycle is 28 days).

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