Castration-Resistant Prostatic CancerPARABONCT02398526
Pain Evaluation in Radium-223 Treated Castration Resistant Prostate Cancer Patients With Bone Metastases
An observational study of Castration-Resistant Prostatic Cancer, run by Bayer at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castration-Resistant Prostatic Cancer
- What is being tested?
- Radium-223 dichloride, (Xofigo, BAY88-8223)
- How many people
- 363 participants
- Where
- 1 siteGermany
- Study dates
- 19 Mar 2015to 15 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of castration resistant prostate cancer patients with bone metastases treated with Radium-223.
Who may be able to join
- 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
Who cannot join
- Patients participating in an investigational program with interventions outside of routine clinical practice or participating in another observational study with Xofigo
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PARABO - Pain Evaluation in Radium-223 (Xofigo®) Treated mCRPC Patients With Bone Metastases - a Non-interventional Study in Nuclear Medicine Centers
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
- Castration-Resistant Prostatic Cancer
- Being tested
- Radium-223 dichloride, (Xofigo, BAY88-8223)
- Keywords
- Observational study, Bone metastases, Hormone Refractory Prostatic Cancer, Xofigo, Radium-223
- Medical subject headings
- Prostatic Neoplasms, Castration-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radium-223 dichloride, (Xofigo, BAY88-8223)Drug
Dosage and treatment duration according to the decision of the treating physician
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Radium-223 dichloride, (Xofigo, BAY88-8223) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain response
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.
Measured: Up to 6 months
Secondary outcomes (21)
Change of pain over time
Determined by evaluating the worst pain item as well as the subscale scores for pain severity and pain interference as determined by patient responses on the BPI-SF questionnaire.
Measured: Up to 6 months from baseline
Change in bone pain related quality of life
As determined by patient responses on the bone pain specific Functional Assessment of Cancer Therapy Quality of Life Measurement in patients with bone pain (FACT-BP) questionnaire
Measured: Up to 6 months from baseline
Pain control rate
As determined by the worst pain item on the BPI-SF patient questionnaire. Pain control is defined as no increase by two points from the baseline BPI-SF worst pain score.
Measured: Up to 6 months
Pain progression rate
As determined by the worst pain item on the BPI-SF patient questionnaire. Pain progression is defined as an increase by two points from the baseline BPI-SF worst pain score at any post baseline assessment.
Measured: Up to 6 months
Time to first pain progression
Defined as the time between the first injection of Radium-223 until an increase in the BPI-SF worst pain item by at least two points
Measured: Up to 6 months
Time to first opioid use
Measured: Up to 5.5 years
Summary description of covariates on pain response
The following covariates will be analyzed: opioid use, assessment of extent of bone metastases, location of bone metastases,level of alkaline phosphatase at baseline, PSA (Prostate Specific Antigen) level at baseline, WHO pain score at baseline, pretreatment with chemotherapy (yes/no), pretreatment with deep androgen ablation by treatment with abiraterone or enzalutamide (yes/no), extent of bone uptake in known lesions, BSI
Measured: Up to 6 months
Relation between bone uptake in known lesions and pain palliation
Only in patients with bone scan prior to start of treatment and a second scan during or within 6 weeks after end of Radium-223 treatment
Measured: Up to 6 months
Dosage of Radium-223
Measured: Up to 5 months
Number of injections of Radium-223
Measured: Up to 5 months
Course of blood count presented as percentage of patients below limit for further injections according to the local product information
Measured: Up to 5 months
Number of participants with Treatment-emergent Adverse Events (TEAE)
Measured: Up to 6 months
Time to next tumor treatment(s) (TTNT)
Defined as the time from the first application of Radium-223 until start of next mCRPC treatment including e.g. chemotherapy and/or hormonal treatment
Measured: Up to 5.5 years
Time to first symptomatic skeletal event (SSE)
Defined as the time between the first injection of Radium-223 until the occurrence of first SSE defined as the first use of external beam radiation therapy to relieve skeletal symptoms, new symptomatic pathological vertebral or non-vertebral bone fractures, spinal cord compression, or tumor-related orthopedic surgical intervention
Measured: Up to 5.5 years
Overall survival
Defined as the time interval from the start of Radium-223 therapy to death, due to any cause. Patients alive at the end of the study will be censored at the last date known to be alive.
Measured: Up to 5.5 years
Bone Scan Index (BSI) as Imaging Biomarker in metastatic castration-resistant prostate cancer (mCRPC)
Evaluated by comparing BSI values before and after Radium-223 treatment as well as by investigating the association of BSI with other outcome parameters like OS
Measured: Up to 6 months
Effect of concomitant drug treatment on pain, quality of life, and overall survival
Exploration of the influence of abiraterone, enzalutamide, opioids and denosumab on OS by number of injections (5-6 vs. 1-4)
Measured: Up to 5.5 years
Time from castration resistance to treatment with Radium-223
Time from verified castration resistance to first injection of Radium-223
Measured: First treatment
Description of covariates on duration of therapy
Description of covariates on duration of therapy (to get ≥ 5 injections versus ≤ 4 injections) of mCRPC patients during treatment with Radium-223.
Measured: Up to 6 months
Factors positively influencing mCRPC patients to get ≥ 5 injections versus ≤ 4 injections
(e.g. concomitant use of antihormonal therapy, no pre-treatment of chemotherapy)
Measured: Up to 6 months
Incidence of pathological fractures, non-pathological fractures and bone associated events during treatment and follow up
Measured: Up to 5.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study start19 Mar 2015
- Primary completion20 May 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Castration-Resistant Prostatic CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398526
- Sponsor's protocol ID
- 17550
- Other IDs
- XF1412DE
- Acronym
- PARABO
- Status last verified
- Oct 2021
- First submitted
- 20 Mar 2015
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37385670
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PARABO - Pain Evaluation in Radium-223 (Xofigo®) Treated mCRPC Patients With Bone Metastases - a Non-interventional Study in Nuclear Medicine Centers
- ClinicalTrials.gov ID
- NCT02398526
- Acronym / sponsor ID
- PARABO / 17550
- Conditions
- Castration-Resistant Prostatic Cancer
- Keywords
- Observational study, Bone metastases, Hormone Refractory Prostatic Cancer, Xofigo, Radium-223
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2015 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radium-223 dichloride | – | Drug: Radium-223 dichloride, (Xofigo, BAY88-8223)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of castration resistant prostate cancer patients with bone metastases treated with Radium-223.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients participating in an investigational program with interventions outside of routine clinical practice or participating in another observational study with Xofigo
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radium-223 dichloride, (Xofigo, BAY88-8223)Dosage and treatment duration according to the decision of the treating physician | Drug | Radium-223 dichloride |
Primary outcome
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.
21 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Derived from this study: PubMed 37385670Palmedo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Castration-Resistant Prostatic Cancer, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain response (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02398526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.