Clinical trial NCT02398526: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Castration-Resistant Prostatic Cancer
Keywords: Observational study
Bone metastases
Hormone Refractory Prostatic Cancer
Xofigo
Radium-223
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-03-25
Enrollment: 363
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of castration resistant prostate cancer patients with bone metastases treated with Radium-223.

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 criteria: 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

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