NCT01929655

Brief Summary

To evaluate the efficacy and safety of the best standard of care plus BAY88-8223 in Japanese patients with CRPC and bone metastases after a multiple administration

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2013

Typical duration for phase_2

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2017

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

3.6 years

First QC Date

August 23, 2013

Last Update Submit

April 20, 2018

Conditions

Prostatic Neoplasms

Keywords

Phase IIsymptomatic castration-resistant prostate cancerbone metastases

Outcome Measures

Primary Outcomes (1)

  • Percentage of change in total alkaline phosphatase from baseline at 12 weeks

    Baseline and 12 weeks

Secondary Outcomes (13)

  • Percentage of change in total alkaline phosphatase at the end of treatment

    Baseline and 24 weeks

  • Percentages of change in bone ALP at 12 weeks

    Baseline and 12 weeks

  • Percentages of change in bone ALP at the end of treatment

    Baseline and 24 weeks

  • The proportion of subjects who have total alkaline phosphatase normalization at 12 weeks

    12 weeks

  • The proportion of subjects who have total alkaline phosphatase normalization at the end of treatment

    24 weeks

  • +8 more secondary outcomes

Study Arms (1)

Radium-223 dichloride

EXPERIMENTAL
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Interventions

Radium-223 dichloride (Xofigo, BAY88-8223)DRUG

BAY88-8223, 50 kBq/kg will be administered as slow bolus intravenous injection 6 times at intervals of 4 weeks between each administration

Radium-223 dichloride

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have received docetaxel or not eligible for the first course of docetaxel, i.e. patients who are not fit enough and willing.
  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Multiple bone metastases
  • Either regular (not occasional) analgesic medication use for cancer-related bone pain or treatment with external beam radiotherapy (EBRT) for bone pain.
  • Best standard of care(BSoC) is regarded as the routine standard of care.

You may not qualify if:

  • Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period
  • History of visceral metastasis, or presence of visceral metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unknown Facility

Kashiwa, Chiba, 277-8577, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 003-0804, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 060-8543, Japan

Location

Unknown Facility

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 236-0004, Japan

Location

Unknown Facility

Sendai, Miyagi, 980-8574, Japan

Location

Unknown Facility

Sayama, Osaka, 589-8511, Japan

Location

Unknown Facility

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, 113-8603, Japan

Location

Unknown Facility

Koto-ku, Tokyo, 135-8550, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Unknown Facility

Chiba, 260-8717, Japan

Location

Unknown Facility

Fukuoka, 812-8582, Japan

Location

Unknown Facility

Kumamoto, 860-0008, Japan

Location

Unknown Facility

Okayama, 700-8558, Japan

Location

Related Publications (1)

  • Matsubara N, Nagamori S, Wakumoto Y, Uemura H, Kimura G, Yokomizo A, Kikukawa H, Mizokami A, Kosaka T, Masumori N, Kawasaki Y, Yonese J, Nasu Y, Fukasawa S, Sugiyama T, Kinuya S, Hosono M, Yamaguchi I, Tsutsui H, Uemura H. Phase II study of radium-223 dichloride in Japanese patients with symptomatic castration-resistant prostate cancer. Int J Clin Oncol. 2018 Feb;23(1):173-180. doi: 10.1007/s10147-017-1176-0. Epub 2017 Aug 2.

    PMID: 28770408DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

radium Ra 223 dichloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2013

First Posted

August 28, 2013

Study Start

September 30, 2013

Primary Completion

May 16, 2017

Study Completion

May 16, 2017

Last Updated

April 24, 2018

Record last verified: 2018-04

Locations

JP(16)