Clinical trial · Observational
Pain Evaluation in Radium-223 Treated Castration Resistant Prostate Cancer Patients With Bone Metastases
PARABO - Pain Evaluation in Radium-223 (Xofigo®) Treated mCRPC Patients With Bone Metastases - a Non-interventional Study in Nuclear Medicine Centers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-Resistant Prostatic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radium-223 dichloride, (Xofigo, BAY88-8223) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Drug: Radium-223 dichloride, (Xofigo, BAY88-8223)
Primary outcomes (1)
- measure
- Pain response
- timeFrame
- Up to 6 months
- description
- 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.
Secondary outcomes (21)
- measure
- Change of pain over time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPalmedo 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 37385670