Pain Evaluation in Radium-223 Treated Castration Resistant Prostate Cancer Patients With Bone Metastases

NCT ID: NCT02398526

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

363 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-19

Study Completion Date

2020-07-15

Brief Summary

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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.

Detailed Description

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Conditions

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Castration-Resistant Prostatic Cancer

Keywords

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Observational study Bone metastases Hormone Refractory Prostatic Cancer Xofigo Radium-223

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

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

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Patients participating in an investigational program with interventions outside of routine clinical practice or participating in another observational study with Xofigo
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Multiple Locations, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 37385670 (View on PubMed)

Related Links

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http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

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XF1412DE

Identifier Type: OTHER

Identifier Source: secondary_id

17550

Identifier Type: -

Identifier Source: org_study_id