---
title: Pain Evaluation in Radium-223 Treated Castration Resistant Prostate Cancer Patients With Bone Metastases
nct_id: NCT02398526
overall_status: COMPLETED
sponsor: Bayer
study_type: OBSERVATIONAL
primary_condition: Castration-Resistant Prostatic Cancer
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02398526.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02398526"
ct_last_update_post_date: 2021-11-02
last_seen_at: "2026-05-12T07:32:46.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Pain Evaluation in Radium-223 Treated Castration Resistant Prostate Cancer Patients With Bone Metastases

**Official Title:** PARABO - Pain Evaluation in Radium-223 (Xofigo®) Treated mCRPC Patients With Bone Metastases - a Non-interventional Study in Nuclear Medicine Centers

**NCT ID:** [NCT02398526](https://clinicaltrials.gov/study/NCT02398526)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 363
- **Lead Sponsor:** Bayer
- **Conditions:** Castration-Resistant Prostatic Cancer
- **Start Date:** 2015-03-19
- **Completion Date:** 2020-07-15
- **CT.gov Last Update:** 2021-11-02

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** MALE
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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.

## Interventions

- **Radium-223 dichloride, (Xofigo, BAY88-8223)** (DRUG) — Dosage and treatment duration according to the decision of the treating physician

## Primary Outcomes

- **Pain response** _(time frame: Up to 6 months)_ — 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

- **Change of pain over time** _(time frame: Up to 6 months from baseline)_
- **Change in bone pain related quality of life** _(time frame: Up to 6 months from baseline)_
- **Pain control rate** _(time frame: Up to 6 months)_
- **Pain progression rate** _(time frame: Up to 6 months)_
- **Time to first pain progression** _(time frame: Up to 6 months)_
- **Time to first opioid use** _(time frame: Up to 5.5 years)_
- **Summary description of covariates on pain response** _(time frame: Up to 6 months)_
- **Relation between bone uptake in known lesions and pain palliation** _(time frame: Up to 6 months)_
- **Dosage of Radium-223** _(time frame: Up to 5 months)_
- **Number of injections of Radium-223** _(time frame: Up to 5 months)_
- **Course of blood count presented as percentage of patients below limit for further injections according to the local product information** _(time frame: Up to 5 months)_
- **Number of participants with Treatment-emergent Adverse Events (TEAE)** _(time frame: Up to 6 months)_
- **Time to next tumor treatment(s) (TTNT)** _(time frame: Up to 5.5 years)_
- **Time to first symptomatic skeletal event (SSE)** _(time frame: Up to 5.5 years)_
- **Overall survival** _(time frame: Up to 5.5 years)_
- **Bone Scan Index (BSI) as Imaging Biomarker in metastatic castration-resistant prostate cancer (mCRPC)** _(time frame: Up to 6 months)_
- **Effect of concomitant drug treatment on pain, quality of life, and overall survival** _(time frame: Up to 5.5 years)_
- **Time from castration resistance to treatment with Radium-223** _(time frame: First treatment)_
- **Description of covariates on duration of therapy** _(time frame: Up to 6 months)_
- **Factors positively influencing mCRPC patients to get ≥ 5 injections versus ≤ 4 injections** _(time frame: Up to 6 months)_
- **Incidence of pathological fractures, non-pathological fractures and bone associated events during treatment and follow up** _(time frame: Up to 5.5 years)_

## Locations (1)

- Multiple Locations, Germany

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|multiple locations||germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02398526.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02398526*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*