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

Bayer

Status: Completed

Conditions: Castration-Resistant Prostatic Cancer

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02398526

XF1412DE (Other Identifier)

17550

Details and patient eligibility

About

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.

Enrollment: 363 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

363 participants in 1 patient group

Radium-223 dichloride

Description:

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.

Treatment:

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