NCT02398526

Brief Summary

This observational prospective single arm cohort study is designed to assess pain and bone pain related quality of life of metastatic Castration Resistant Prostate Cancer (mCRPC) patients receiving Radium-223 in a real life nuclear medicine practice setting. In addition, overall survival, time to next tumor treatment (TTNT), time to first symptomatic skeletal event (SSE), course of blood counts, and safety will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
363

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 19, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

5.2 years

First QC Date

March 20, 2015

Last Update Submit

November 1, 2021

Conditions

Castration-Resistant Prostatic Cancer

Keywords

Observational studyBone metastasesHormone Refractory Prostatic CancerXofigoRadium-223

Outcome Measures

Primary Outcomes (1)

  • Pain response

    Determined by the worst pain item on the Brief Pain Inventory - Short Form (BPI-SF) patient questionnaire. A clinically meaningful pain response is defined as an improvement of two points from the baseline BPI-SF worst pain score at any post-baseline assessment.

    Up to 6 months

Secondary Outcomes (21)

  • Change of pain over time

    Up to 6 months from baseline

  • Change in bone pain related quality of life

    Up to 6 months from baseline

  • Pain control rate

    Up to 6 months

  • Pain progression rate

    Up to 6 months

  • Time to first pain progression

    Up to 6 months

  • +16 more secondary outcomes

Study Arms (1)

Radium-223 dichloride

Male patients with a diagnosis of CRPC with symptomatic bone metastases without known visceral metastases will be enrolled after the decision for treatment with Radium-223 has been made by the attending physician according to his/her medical practice.

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

Interventions

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

Dosage and treatment duration according to the decision of the treating physician

Radium-223 dichloride

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of castration resistant prostate cancer patients with bone metastases treated with Radium-223.

You may qualify if:

  • Adult male patients diagnosed with CRPC with symptomatic bone metastases without known visceral metastases
  • Decision to initiate treatment with Radium-223 was made as per investigator's routine treatment practice

You may not qualify if:

  • Patients participating in an investigational program with interventions outside of routine clinical practice or participating in another observational study with Xofigo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, Germany

Location

Related Publications (1)

  • Palmedo H, Ahmadzadehfar H, Eschmann S, Niesen A, Schonberger J, Barsegian V, Liepe K, Mottaghy FM, Guan R, Pinkert J, Sandstrom P, Herrmann K. Pain Outcomes in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with 223Ra: PARABO, a Prospective, Noninterventional Study. J Nucl Med. 2023 Sep;64(9):1392-1398. doi: 10.2967/jnumed.123.265557. Epub 2023 Jun 29.

    PMID: 37385670DERIVED

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant

Interventions

radium Ra 223 dichloride

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2015

First Posted

March 25, 2015

Study Start

March 19, 2015

Primary Completion

May 20, 2020

Study Completion

July 15, 2020

Last Updated

November 2, 2021

Record last verified: 2021-10

Locations

DE(1)