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Standard Dose Versus High Dose and Versus Extended Standard Dose Radium-223 Dichloride in Castration-resistant Prostate Cancer Metastatic to the Bone

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Radium-223 dichloride (Xofigo, BAY88-8223)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate

  • Castration-resistant disease defined as:

    • Serum testosterone level: ≤ 50 ng/dL (1.7 nmol/L)
    • Bilateral orchiectomy or maintenance on androgen ablation therapy with luteinizing-hormone-releasing hormone (LHRH) agonist or antagonist, or polyestradiol phosphate
    • Serum PSA (Prostate specific antigen) progression defined as 2 subsequent increases in PSA over a previous reference value (a minimum of 2 ng/mL [μg/L]) OR
    • Radiographic evidence of disease progression in bone (according to Prostate Cancer Clinical Trials Working Group 2 [PCWG2] criteria) with or without PSA progression
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2. In case of ECOG PS 2, the PS has to be due to metastatic prostate cancer to the bone.
  • Two or more skeletal metastases (≥ 2 hot spots) on bone scintigraphy within 8 weeks of randomization

Exclusion Criteria:

  • History of visceral metastasis, or visceral metastases
  • Lymphadenopathy with lymph nodes exceeding 3 cm in short axis diameter
  • Central nervous system (CNS) metastases
  • Treatment with cytotoxic chemotherapy for prostate cancer within the previous 4 weeks prior to randomization, or planned treatment with cytotoxic chemotherapy agents for prostate cancer during the treatment period or follow-up
  • Chronic conditions associated with non-malignant abnormal bone growth (e.g. confirmed Paget's disease of bone)
  • Prior treatment with radium-223 dichloride
  • Prior systemic radiotherapy and hemibody external radiotherapy

Sites / Locations

  • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Hospital de Clínicas de Porto Alegre
  • Instituto do Câncer do Estado de São Paulo
  • IBCC - Instituto Brasileiro de Controle do Cancer
  • Hospital Israelita Albert Einstein

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Radium-223 dichloride (Standard dose)

Radium-223 dichloride (High dose)

Radium-223 dichloride (Extended standard dose)

Arm Description

One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update).

One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 80 kBq/kg body weight (88 kBq/kg after implementation of NIST update).

One injection to be administered every 4 weeks up to 12 injections. The dose per injection is 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update).

Outcomes

Primary Outcome Measures

Number of Participants With an Event Defining SSE Free Survival - High Dose vs. Standard Dose
Symptomatic skeletal event (SSE) free survival is based on the following events: the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); the occurrence of spinal cord compression; a tumor related orthopedic surgical intervention, and death. In this evaluation - comparison 1, SSE-FS following randomization is defined in ITT participants as the time from randomization to an SSE or death, whichever occurs first.
Symptomatic Skeletal Event-Free Survival - High Dose vs. Standard Dose
In this evaluation - comparison 1, SSE-FS following randomization is defined in ITT participants as the time from randomization to an SSE or death, whichever occurs first.
Number of Participants With an Event Defining SSE Free Survival - Extended Dose vs. Standard Dose
Symptomatic skeletal event (SSE) free survival is based on the following events: the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); the occurrence of spinal cord compression; a tumor related orthopedic surgical intervention, and death. In this evaluation - Comparison 2, SSE-FS from 6th dose is defined in W24 participants as the time from Week 24 baseline (the 6th dose date) to an SSE or death, whichever occurs first.
Symptomatic Skeletal Event-Free Survival - Extended Dose vs. Standard Dose
In this evaluation - Comparison 2, SSE-FS from 6th dose is defined in W24 participants as the time from Week 24 baseline (the 6th dose date) to an SSE or death, whichever occurs first.
Number of Participants With an Event Defining SSE Free Survival - Three Dose Groups As Randomized
Symptomatic skeletal event (SSE) free survival is based on the following events: the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); the occurrence of spinal cord compression; a tumor related orthopedic surgical intervention, and death.
Symptomatic Skeletal Event Free Survival - Three Dose Groups As Randomized
Symptomatic skeletal event (SSE) is defined as follows: The use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; The occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); The occurrence of spinal cord compression; A tumor related orthopedic surgical intervention.

Secondary Outcome Measures

Number of Participants With an Overall Survival Event - High Dose vs. Standard Dose
Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.
Overall Survival - High Dose vs. Standard Dose
Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.
Number of Participants With an Overall Survival Event - Extended Dose vs. Standard Dose
Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.
Overall Survival - Extended Dose vs. Standard Dose
Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.
Number of Participants With an Overall Survival - Three Dose Groups As Randomized
Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.
Overall Survival Event - Three Dose Groups as Randomized
Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.
Number of Participants With First Symptomatic Skeletal Event - High Dose vs. Standard Dose
Symptomatic skeletal event (SSE) is defined as follows: The use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; The occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); The occurrence of spinal cord compression; A tumor related orthopedic surgical intervention.
Time to First Symptomatic Skeletal Event - High Dose vs. Standard Dose
Time to first SSE is defined as the time in days from the applicable start date to the first SSE on or following the start date.
Number of Participants With First Symptomatic Skeletal Event - Extended Dose vs. Standard Dose
Symptomatic skeletal event (SSE) is defined as follows: The use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; The occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); The occurrence of spinal cord compression; A tumor related orthopedic surgical intervention.
Time to First Symptomatic Skeletal Event - Extended Dose vs. Standard Dose
Time to first SSE is defined as the time in days from the applicable start date to the first SSE on or following the start date.
Number of Participants With First Symptomatic Skeletal Event - Three Dose Groups as Randomized
Symptomatic skeletal event (SSE) is defined as follows: The use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; The occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); The occurrence of spinal cord compression; A tumor related orthopedic surgical intervention.
Time to First Symptomatic Skeletal Event - Three Dose Groups as Randomized
Time to first SSE is defined as the time in days from the applicable start date to the first SSE on or following the start date.
Number of Participants With a Radiological Progression Event-Free - High Dose vs. Standard Dose
Radiological progression of soft tissue disease is determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Magnetic resonance imaging (MRI) or computed tomography (CT) scans. Radiological progression of osseous disease is determined according to adapted PCWG2 criteria based on whole body technetium-99 bone scans. Radiological bone progression is determined if at least one of the following criteria is met: The first bone scan with ≥2 new lesions compared to baseline is observed <12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); or The first bone scan with ≥2 new lesions compared to baseline is observed ≥12 weeks from randomization and the new lesions are verified on the next bone scan ≥6 weeks later (a total of ≥2 new lesions compared to baseline).
Radiological Progression Free Survival - High Dose vs. Standard Dose
Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.
Number of Participants With a Radiological Progression Event-Free - Extended Dose vs. Standard Dose
Radiological progression of soft tissue disease is determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Magnetic resonance imaging (MRI) or Computed tomography (CT) scans. Radiological progression of osseous disease is determined according to adapted PCWG2 criteria based on whole body technetium-99 bone scans.
Radiological Progression Free Survival - Extended Dose vs. Standard Dose
Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.
Number of Participants With a Radiological Progression Event-Free - Three Dose Groups as Randomized
Radiological progression of soft tissue disease is determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Magnetic resonance imaging (MRI) or Computed tomography (CT) scans. Radiological progression of osseous disease is determined according to adapted Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria based on whole body technetium-99 bone scans.
Radiological Progression Free Survival - Three Dose Groups as Randomized
Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.
Number of Participants With a Radiological Progression Event - High Dose vs. Standard Dose
Radiological progression of soft tissue disease is determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Magnetic resonance imaging (MRI) or Computed tomography (CT) scans. Radiological progression of osseous disease is determined according to adapted Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria based on whole body technetium-99 bone scans.
Time to Radiological Progression - High Dose vs. Standard Dose
Time to radiological progression is defined as the time in days from the applicable start date to the date of subsequent radiological progression. Participants without radiological progression as of database cut-off date, whether or not surviving, were censored at the last radiological progression assessment.
Number of Participants With a Radiological Progression Event - Extended Dose vs. Standard Dose
Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.
Time to Radiological Progression - Extended Dose vs. Standard Dose
Time to radiological progression is defined as the time in days from the applicable start date to the date of subsequent radiological progression. Participants without radiological progression as of database cut-off date, whether or not surviving, were censored at the last radiological progression assessment.
Number of Participants With a Radiological Progression Event - Three Dose Groups as Randomized
Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.
Time to Radiological Progression - Three Dose Groups as Randomized
Time to radiological progression is defined as the time in days from the applicable start date to the date of subsequent radiological progression. Participants without radiological progression as of database cut-off date, whether or not surviving, were censored at the last radiological progression assessment.
Timepoint Pain Improvement Rate - Three Dose Groups as Randomized
Timepoint pain improvement rate is defined as the proportion of participants with a 30% and 2-point decrease in Worst pain score (WPS) from baseline over 2 consecutive assessment periods conducted at least 4 weeks apart among participants with a WPS score ≥ 4 at baseline.
Timepoint Pain Improvement Rate - Extended Dose vs. Standard Dose
Timepoint pain improvement rate is defined as the proportion of participants with a 30% and 2-point decrease in Worst pain score (WPS) from baseline over 2 consecutive assessment periods conducted at least 4 weeks apart among participants with a WPS score ≥ 4 at baseline.
Number of Participants With a Pain Progression Event - High Dose vs. Standard Dose
Participants were divided in 3 groups according to baseline pain evaluation: asymptomatic subjects (WPS 0 to < 1 at baseline); mildly symptomatic subjects (WPS 1-3 at baseline); and symptomatic subjects with WPS > 3 and ≤ 7 at baseline). Pain progression was defined as the occurrence of a pain increase of 2 or more points in the average (i.e., average of 7-day assessments) "worst pain in 24 hours" score from baseline observed at 2 consecutive evaluations ≥ 4 weeks apart. Participants with insufficient applicable baseline assessments or without adequate post-baseline assessments were to be censored at the applicable baseline date.
Time to Pain Progression - High Dose vs. Standard Dose
The time to pain progression is defined for each applicable baseline for applicable participants as the time (in days) from the respective baseline until occurrence of the first post-baseline pain progression event.
Number of Participants With a Pain Progression Event - Extended Dose vs. Standard Dose
Pain progression is defined for each baseline in participants evaluable for pain progression at the applicable baseline, i.e., participants with a WPS of ≤ 7 at the respective baseline assessment.
Time to Pain Progression - Extended Dose vs. Standard Dose
The time to pain progression is defined for each applicable baseline for applicable participants as the time (in days) from the respective baseline until occurrence of the first post-baseline pain progression event.
Number of Participants With a Pain Progression Event - Three Dose Groups as Randomized
Pain progression is defined for each baseline in participants evaluable for pain progression at the applicable baseline, i.e., participants with a WPS of ≤ 7 at the respective baseline assessment.
Time to Pain Progression - Three Dose Groups as Randomized
The time to pain progression is defined for each applicable baseline for applicable participants as the time (in days) from the respective baseline until occurrence of the first post-baseline pain progression event.
Number of Participants With Treatment-Emergent Adverse Events
Treatment-emergent adverse events are events starting or worsening from the initiation of treatment until 30 days after the last administration of radium-223 dichloride. The intensity of an AE is classified according to the grades specified by the National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE).

Full Information

First Posted
December 24, 2013
Last Updated
June 30, 2019
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02023697
Brief Title
Standard Dose Versus High Dose and Versus Extended Standard Dose Radium-223 Dichloride in Castration-resistant Prostate Cancer Metastatic to the Bone
Official Title
A Three Arm Randomized, Open-label Phase II Study of Radium-223 Dichloride 50 kBq/kg (55 kBq/kg After Implementation of NIST Update) Versus 80 kBq/kg (88 kBq/kg After Implementation of NIST Update), and Versus 50 kBq/kg (55 kBq/kg After Implementation of NIST Update) in an Extended Dosing Schedule in Subjects With Castration-resistant Prostate Cancer Metastatic to the Bone
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 10, 2014 (Actual)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
August 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will assess different doses and regimens of radium-223 dichloride on the incidence of symptomatic skeletal events. Eligible subjects must have castration resistant prostate cancer with 2 or more skeletal metastases documented within 8 weeks of randomization. Subjects will be randomized to one of 3 treatment arms in a 1:1:1 fashion: a standard regimen of radium-223 dichloride of 50 kBq/kg (55 kBq/kg after implementation of NIST update) injections every month for 6 months, a high dose regimen of 80 kBq/kg (88 kBq/kg after implementation of NIST update)injections every month for 6 months or an extended duration regimen of 50 kBq/kg (55 kBq/kg after implementation of NIST update) injections every month for 12 months. Following the treatment phase, subjects will be followed up every 12 weeks for a minimum of 2 years, at which point they will enter a long term follow-up period during which they are seen every 6 months for up to 7 years after the last dose of radium dichloride. Symptomatic skeletal event and safety endpoints will be assessed at each clinic visit. Pain and analgesic use data will be collected every 4 weeks through Week 48. Additionally, radiological assessments including MRI/CT of the abdomen and pelvis and chest CT, as well as technetium-99 bone scans will be performed at Weeks 8, 16, and 24 and continue every 12 weeks thereafter until disease progression is documented in either the bone or in soft tissue. Radiological imaging will be evaluated by blinded central review.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
391 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radium-223 dichloride (Standard dose)
Arm Type
Experimental
Arm Description
One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update).
Arm Title
Radium-223 dichloride (High dose)
Arm Type
Experimental
Arm Description
One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 80 kBq/kg body weight (88 kBq/kg after implementation of NIST update).
Arm Title
Radium-223 dichloride (Extended standard dose)
Arm Type
Experimental
Arm Description
One injection to be administered every 4 weeks up to 12 injections. The dose per injection is 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update).
Intervention Type
Drug
Intervention Name(s)
Radium-223 dichloride (Xofigo, BAY88-8223)
Primary Outcome Measure Information:
Title
Number of Participants With an Event Defining SSE Free Survival - High Dose vs. Standard Dose
Description
Symptomatic skeletal event (SSE) free survival is based on the following events: the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); the occurrence of spinal cord compression; a tumor related orthopedic surgical intervention, and death. In this evaluation - comparison 1, SSE-FS following randomization is defined in ITT participants as the time from randomization to an SSE or death, whichever occurs first.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Symptomatic Skeletal Event-Free Survival - High Dose vs. Standard Dose
Description
In this evaluation - comparison 1, SSE-FS following randomization is defined in ITT participants as the time from randomization to an SSE or death, whichever occurs first.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Number of Participants With an Event Defining SSE Free Survival - Extended Dose vs. Standard Dose
Description
Symptomatic skeletal event (SSE) free survival is based on the following events: the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); the occurrence of spinal cord compression; a tumor related orthopedic surgical intervention, and death. In this evaluation - Comparison 2, SSE-FS from 6th dose is defined in W24 participants as the time from Week 24 baseline (the 6th dose date) to an SSE or death, whichever occurs first.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Symptomatic Skeletal Event-Free Survival - Extended Dose vs. Standard Dose
Description
In this evaluation - Comparison 2, SSE-FS from 6th dose is defined in W24 participants as the time from Week 24 baseline (the 6th dose date) to an SSE or death, whichever occurs first.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Number of Participants With an Event Defining SSE Free Survival - Three Dose Groups As Randomized
Description
Symptomatic skeletal event (SSE) free survival is based on the following events: the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); the occurrence of spinal cord compression; a tumor related orthopedic surgical intervention, and death.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Symptomatic Skeletal Event Free Survival - Three Dose Groups As Randomized
Description
Symptomatic skeletal event (SSE) is defined as follows: The use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; The occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); The occurrence of spinal cord compression; A tumor related orthopedic surgical intervention.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Secondary Outcome Measure Information:
Title
Number of Participants With an Overall Survival Event - High Dose vs. Standard Dose
Description
Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Overall Survival - High Dose vs. Standard Dose
Description
Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Number of Participants With an Overall Survival Event - Extended Dose vs. Standard Dose
Description
Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Overall Survival - Extended Dose vs. Standard Dose
Description
Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Number of Participants With an Overall Survival - Three Dose Groups As Randomized
Description
Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Overall Survival Event - Three Dose Groups as Randomized
Description
Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Number of Participants With First Symptomatic Skeletal Event - High Dose vs. Standard Dose
Description
Symptomatic skeletal event (SSE) is defined as follows: The use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; The occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); The occurrence of spinal cord compression; A tumor related orthopedic surgical intervention.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Time to First Symptomatic Skeletal Event - High Dose vs. Standard Dose
Description
Time to first SSE is defined as the time in days from the applicable start date to the first SSE on or following the start date.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Number of Participants With First Symptomatic Skeletal Event - Extended Dose vs. Standard Dose
Description
Symptomatic skeletal event (SSE) is defined as follows: The use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; The occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); The occurrence of spinal cord compression; A tumor related orthopedic surgical intervention.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Time to First Symptomatic Skeletal Event - Extended Dose vs. Standard Dose
Description
Time to first SSE is defined as the time in days from the applicable start date to the first SSE on or following the start date.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Number of Participants With First Symptomatic Skeletal Event - Three Dose Groups as Randomized
Description
Symptomatic skeletal event (SSE) is defined as follows: The use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; The occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); The occurrence of spinal cord compression; A tumor related orthopedic surgical intervention.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Time to First Symptomatic Skeletal Event - Three Dose Groups as Randomized
Description
Time to first SSE is defined as the time in days from the applicable start date to the first SSE on or following the start date.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Number of Participants With a Radiological Progression Event-Free - High Dose vs. Standard Dose
Description
Radiological progression of soft tissue disease is determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Magnetic resonance imaging (MRI) or computed tomography (CT) scans. Radiological progression of osseous disease is determined according to adapted PCWG2 criteria based on whole body technetium-99 bone scans. Radiological bone progression is determined if at least one of the following criteria is met: The first bone scan with ≥2 new lesions compared to baseline is observed <12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); or The first bone scan with ≥2 new lesions compared to baseline is observed ≥12 weeks from randomization and the new lesions are verified on the next bone scan ≥6 weeks later (a total of ≥2 new lesions compared to baseline).
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Radiological Progression Free Survival - High Dose vs. Standard Dose
Description
Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Number of Participants With a Radiological Progression Event-Free - Extended Dose vs. Standard Dose
Description
Radiological progression of soft tissue disease is determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Magnetic resonance imaging (MRI) or Computed tomography (CT) scans. Radiological progression of osseous disease is determined according to adapted PCWG2 criteria based on whole body technetium-99 bone scans.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Radiological Progression Free Survival - Extended Dose vs. Standard Dose
Description
Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Number of Participants With a Radiological Progression Event-Free - Three Dose Groups as Randomized
Description
Radiological progression of soft tissue disease is determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Magnetic resonance imaging (MRI) or Computed tomography (CT) scans. Radiological progression of osseous disease is determined according to adapted Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria based on whole body technetium-99 bone scans.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Radiological Progression Free Survival - Three Dose Groups as Randomized
Description
Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Number of Participants With a Radiological Progression Event - High Dose vs. Standard Dose
Description
Radiological progression of soft tissue disease is determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Magnetic resonance imaging (MRI) or Computed tomography (CT) scans. Radiological progression of osseous disease is determined according to adapted Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria based on whole body technetium-99 bone scans.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Time to Radiological Progression - High Dose vs. Standard Dose
Description
Time to radiological progression is defined as the time in days from the applicable start date to the date of subsequent radiological progression. Participants without radiological progression as of database cut-off date, whether or not surviving, were censored at the last radiological progression assessment.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Number of Participants With a Radiological Progression Event - Extended Dose vs. Standard Dose
Description
Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Time to Radiological Progression - Extended Dose vs. Standard Dose
Description
Time to radiological progression is defined as the time in days from the applicable start date to the date of subsequent radiological progression. Participants without radiological progression as of database cut-off date, whether or not surviving, were censored at the last radiological progression assessment.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Number of Participants With a Radiological Progression Event - Three Dose Groups as Randomized
Description
Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Time to Radiological Progression - Three Dose Groups as Randomized
Description
Time to radiological progression is defined as the time in days from the applicable start date to the date of subsequent radiological progression. Participants without radiological progression as of database cut-off date, whether or not surviving, were censored at the last radiological progression assessment.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Timepoint Pain Improvement Rate - Three Dose Groups as Randomized
Description
Timepoint pain improvement rate is defined as the proportion of participants with a 30% and 2-point decrease in Worst pain score (WPS) from baseline over 2 consecutive assessment periods conducted at least 4 weeks apart among participants with a WPS score ≥ 4 at baseline.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Timepoint Pain Improvement Rate - Extended Dose vs. Standard Dose
Description
Timepoint pain improvement rate is defined as the proportion of participants with a 30% and 2-point decrease in Worst pain score (WPS) from baseline over 2 consecutive assessment periods conducted at least 4 weeks apart among participants with a WPS score ≥ 4 at baseline.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Number of Participants With a Pain Progression Event - High Dose vs. Standard Dose
Description
Participants were divided in 3 groups according to baseline pain evaluation: asymptomatic subjects (WPS 0 to < 1 at baseline); mildly symptomatic subjects (WPS 1-3 at baseline); and symptomatic subjects with WPS > 3 and ≤ 7 at baseline). Pain progression was defined as the occurrence of a pain increase of 2 or more points in the average (i.e., average of 7-day assessments) "worst pain in 24 hours" score from baseline observed at 2 consecutive evaluations ≥ 4 weeks apart. Participants with insufficient applicable baseline assessments or without adequate post-baseline assessments were to be censored at the applicable baseline date.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Time to Pain Progression - High Dose vs. Standard Dose
Description
The time to pain progression is defined for each applicable baseline for applicable participants as the time (in days) from the respective baseline until occurrence of the first post-baseline pain progression event.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Number of Participants With a Pain Progression Event - Extended Dose vs. Standard Dose
Description
Pain progression is defined for each baseline in participants evaluable for pain progression at the applicable baseline, i.e., participants with a WPS of ≤ 7 at the respective baseline assessment.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Time to Pain Progression - Extended Dose vs. Standard Dose
Description
The time to pain progression is defined for each applicable baseline for applicable participants as the time (in days) from the respective baseline until occurrence of the first post-baseline pain progression event.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Number of Participants With a Pain Progression Event - Three Dose Groups as Randomized
Description
Pain progression is defined for each baseline in participants evaluable for pain progression at the applicable baseline, i.e., participants with a WPS of ≤ 7 at the respective baseline assessment.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Time to Pain Progression - Three Dose Groups as Randomized
Description
The time to pain progression is defined for each applicable baseline for applicable participants as the time (in days) from the respective baseline until occurrence of the first post-baseline pain progression event.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Title
Number of Participants With Treatment-Emergent Adverse Events
Description
Treatment-emergent adverse events are events starting or worsening from the initiation of treatment until 30 days after the last administration of radium-223 dichloride. The intensity of an AE is classified according to the grades specified by the National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE).
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)
Other Pre-specified Outcome Measures:
Title
Number of Participants With Change in Analgesic Use From Baseline to Worst Status Post-Baseline
Description
Analgesic use in this study were captured via two methods: Analgesic concomitant medication case report form, where the physician records the analgesic medication prescribed to manage pain; 24 hour analgesic consumption case report form, in which all analgesic medication taken in the last 24 hours.
Time Frame
From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the prostate Castration-resistant disease defined as: Serum testosterone level: ≤ 50 ng/dL (1.7 nmol/L) Bilateral orchiectomy or maintenance on androgen ablation therapy with luteinizing-hormone-releasing hormone (LHRH) agonist or antagonist, or polyestradiol phosphate Serum PSA (Prostate specific antigen) progression defined as 2 subsequent increases in PSA over a previous reference value (a minimum of 2 ng/mL [μg/L]) OR Radiographic evidence of disease progression in bone (according to Prostate Cancer Clinical Trials Working Group 2 [PCWG2] criteria) with or without PSA progression Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2. In case of ECOG PS 2, the PS has to be due to metastatic prostate cancer to the bone. Two or more skeletal metastases (≥ 2 hot spots) on bone scintigraphy within 8 weeks of randomization Exclusion Criteria: History of visceral metastasis, or visceral metastases Lymphadenopathy with lymph nodes exceeding 3 cm in short axis diameter Central nervous system (CNS) metastases Treatment with cytotoxic chemotherapy for prostate cancer within the previous 4 weeks prior to randomization, or planned treatment with cytotoxic chemotherapy agents for prostate cancer during the treatment period or follow-up Chronic conditions associated with non-malignant abnormal bone growth (e.g. confirmed Paget's disease of bone) Prior treatment with radium-223 dichloride Prior systemic radiotherapy and hemibody external radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0330
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15215
Country
United States
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
Irmandade Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90470 340
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Instituto do Câncer do Estado de São Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
IBCC - Instituto Brasileiro de Controle do Cancer
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
03102 002
Country
Brazil
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05651-901
Country
Brazil
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
City
Chomutov
ZIP/Postal Code
430 12
Country
Czechia
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
City
Nantes
ZIP/Postal Code
44805
Country
France
City
Vandoeuvre les Nancy
ZIP/Postal Code
54500
Country
France
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
City
Arezzo
State/Province
Toscana
ZIP/Postal Code
52100
Country
Italy
City
Busan
State/Province
Busan Gwang''yeogsi
ZIP/Postal Code
49241
Country
Korea, Republic of
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
06273
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Palma de Mallorca
State/Province
Illes Baleares
ZIP/Postal Code
07120
Country
Spain
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
City
Karlstad
ZIP/Postal Code
652 30
Country
Sweden
City
Sundsvalls
ZIP/Postal Code
851 86
Country
Sweden
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
112
Country
Taiwan
City
Guishan Township
State/Province
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
City
Bebington
State/Province
Merseyside
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
City
Taunton
State/Province
Somerset
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31959342
Citation
Sternberg CN, Saad F, Graff JN, Peer A, Vaishampayan UN, Leung E, Rosenbaum E, Gurney H, Epstein RJ, Davis ID, Wu B, Trandafir L, Wagner VJ, Hussain M. A randomised phase II trial of three dosing regimens of radium-223 in patients with bone metastatic castration-resistant prostate cancer. Ann Oncol. 2020 Feb;31(2):257-265. doi: 10.1016/j.annonc.2019.10.025. Epub 2019 Dec 23.
Results Reference
derived
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer Healthcare products.

Learn more about this trial

Standard Dose Versus High Dose and Versus Extended Standard Dose Radium-223 Dichloride in Castration-resistant Prostate Cancer Metastatic to the Bone

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