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

Sponsor

Bayer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04521361

Collaborator

(none)

Enrollment

Locations

Arms

64.3

Anticipated Duration (Months)

3.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 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).

Condition or Disease	Intervention/Treatment	Phase
Bone Metastatic Castration-resistant Prostate Cancer	Drug: Radium-223 dichloride (Xofigo, BAY88-8223)	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Nov 16, 2020

Anticipated Primary Completion Date :

Feb 26, 2026

Anticipated Study Completion Date :

Mar 28, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with Low extent of disease Adult men with bone mCRPC having < 6 bone metastases	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).
Experimental: Patients with High extent of disease Adult men with bone mCRPC having ≥ 6 bone metastases	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).

Arm

Intervention/Treatment

Experimental: Patients with Low extent of disease

Adult men with bone mCRPC having < 6 bone metastases

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).

Experimental: Patients with High extent of disease

Adult men with bone mCRPC having ≥ 6 bone metastases

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).

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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).]
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).]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ordensklinikum Linz GmbH Elisabethinen	Linz	Oberösterreich	Austria	4020
2	Uniklinikum Salzburg - Landeskrankenhaus	Salzburg		Austria	5020
3	HUS, Meilahden sairaala	Helsinki		Finland	00290
4	Institut du Cancer de Montpellier - Val d'Aurelle	Montpellier Cedex		France	34298
5	Centre Hospitalier Lyon Sud	Pierre Benite		France	69495
6	Institut de Cancérologie de l'Ouest - Saint Herblain	Saint Herblain		France	44805
7	Institut Claudius Regaud - iUCT Oncopole	Toulouse Cedex 9		France	31059
8	Institut Gustave Roussy	Villejuif Cedex		France	94805
9	Universitätsklinikum Münster (UKM)	Münster	Nordrhein-Westfalen	Germany	48149
10	Rambam Health Corporation	Haifa		Israel	3109601
11	AUSL-IRCCS di Reggio Emilia	Reggio Emilia	Emilia-Romagna	Italy	42123
12	National Cancer Institute	Vilnius		Lithuania	LT-08660
13	Vilnius University Hospital Santaros Klinikos	Vilnius		Lithuania	LT-08661
14	Royal Marsden NHS Trust (Surrey)	Sutton	Surrey	United Kingdom	SM2 5PT
15	University College London Hospitals NHS Foundation Trust	London		United Kingdom	NW1 2PG
16	Guy's and St. Thomas' NHS Trust, St. Thomas' Hospital	London		United Kingdom	SE1 7EH