Prostate Cancer, Castration ResistantNCT03419442
Multi-academic Center Study of Xofigo Patients
An observational study of Prostate Cancer, Castration Resistant, run by Bayer at 1 site in United States.
Trial summary
The study will be conducted from a real-world perspective to describe treatment sequences involving radium-223 and chemotherapy in patients with metastatic castrate resistant prostate cancer (mCRPC) and assess overall survival (OS) associated with treatment sequences involving radium-223 and chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Castration Resistant
- What is being tested?
- Xofigo, Taxotere and Jevtana
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2018to 22 Oct 2019
- 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 be comprised of patients with CRPC and bone metastasis who have received at least one dose of radium-223 at one of the participating cancer centers. The participating centers are 4 tertiary care cancer centers (Dana Farber Cancer Institute, Tulane Cancer Center, Memorial Sloan Kettering Cancer Center and Beth Israel Deaconess Medical Center)
Who may be able to join
- Received at least one dose of radium-223 after mCRPC diagnosis
- Received at least one prescription or dose of chemotherapy for treatment of mCRPC
Who cannot join
- No documented visceral metastasis at initiation of radium-223
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective, Longitudinal Multi-Center Study of Radium-223 in Patients With Metastatic Castration-Resistant Prostate Cancer
The study will be conducted from a real-world perspective to describe treatment sequences involving radium-223 and chemotherapy in patients with metastatic castrate resistant prostate cancer (mCRPC) and assess overall survival (OS) associated with treatment sequences involving radium-223 and chemotherapy. While clinical trials of radium-223 has demonstrated a survival benefit in the treatment of mCRPC, both pre and post- docetaxel, study lacked exposure to second generation androgens and hence could not assess outcomes pre or post abiraterone or enzalutamide.
The specific objective of this study is to describe and compare the clinical outcomes between treatment sequences for patients with mCRPC where 1) radium-223 is used (alone or in combination with abiraterone or enzalutamide) prior to chemotherapy versus 2) radium-223 used after chemotherapy in the treatment of mCRPC. The secondary objectives are to describe the safety patterns of docetaxel use among mCRPC patients who received chemotherapy post radium-223.
- Conditions
- Prostate Cancer, Castration Resistant
- Being tested
- Xofigo, Taxotere, Jevtana
- Keywords
- Prostate cancer, Bone metastases, Xofigo
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XofigoDrug
Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injection
TaxotereDrug
Docetaxel injection 75mg/m2 every 3 weeks
JevtanaDrug
Cabazitaxel injection 25mg/m2 intravenously once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ra-223 therapy before chemotherapy | Treatment sequence 1 will include all mCRPC patients who received Ra-223 alone or in combination with abiraterone or enzalutamide and subsequently received chemotherapy Receives: Drug: Xofigo; Drug: Taxotere; Drug: Jevtana | |
| Ra-223 after chemotherapy | Treatment sequence 2 includes all mCRPC patients who received chemotherapy before Radium 223 therapy Receives: Drug: Xofigo; Drug: Taxotere; Drug: Jevtana |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Survival will be measured from initiation of first line therapy after mCRPC diagnosis until the date of death (from any cause).
Measured: Up to 30 months
Time to symtomatic skeletal event(SSE)
Measured as the time from initiation of first-line therapy after mCRPC diagnosis until first SSE; for the exploratory analysis, measured as the time from initiation of radium-223 until first SSE. SSE will be identified based on the ALSYMPCA trial definition: first use of external-beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic vertebral or non-vertebral bone fractures, spinal cord compression, or tumor-related orthopedic surgical intervention
Measured: Up to 30 months
Reasons for treatment discontinuation
data for treatment discontinuation for each mCRPC therapy will be collected
Measured: Up to 30 months
Secondary outcomes (6)
Laboratory-based outcomes collected by questionnaire
Data will be collected as available from initiation of docetaxel until 3 months following last dose of docetaxel
Measured: Up to 30 months
Treatments received
measured as Yes/No
Measured: Up to 30 months
Number of hospitalizations
along with the discharge diagnosis, as recorded in medical charts or discharge summaries
Measured: Up to 30 months
PSA PFS
defined as death or an increase above PSA nadir by ≥25% and ≥2 ng/mL (PCWG 2008 definition for Prostate specific antigen(PSA) Progression-free survival(PFS))
Measured: Up to 30 months
Non-laboratory based clinically relevant safety outcomes
documented in medical records
Measured: Up to 30 months
hospital length of stay
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start3 Dec 2018
- Primary completion22 Oct 2019
- Study completion22 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer, Castration ResistantStudies 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
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419442
- Sponsor's protocol ID
- 19863
- Status last verified
- Oct 2020
- First submitted
- 4 Jan 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Longitudinal Multi-Center Study of Radium-223 in Patients With Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT03419442
- Acronym / sponsor ID
- 19863
- Conditions
- Prostate Cancer, Castration Resistant
- Keywords
- Prostate cancer, Bone metastases, Xofigo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 22 Oct 2019 (actual)
- Study completion
- 22 Oct 2019 (actual)
- First posted
- 5 Feb 2018 (actual)
- 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.
The study will be conducted from a real-world perspective to describe treatment sequences involving radium-223 and chemotherapy in patients with metastatic castrate resistant prostate cancer (mCRPC) and assess overall survival (OS) associated with treatment sequences involving radium-223 and chemotherapy. While clinical trials of radium-223 has demonstrated a survival benefit in the treatment of mCRPC, both pre and post- docetaxel, study lacked exposure to second generation androgens and hence could not assess outcomes pre or post abiraterone or enzalutamide.
The specific objective of this study is to describe and compare the clinical outcomes between treatment sequences for patients with mCRPC where 1) radium-223 is used (alone or in combination with abiraterone or enzalutamide) prior to chemotherapy versus 2) radium-223 used after chemotherapy in the treatment of mCRPC. The secondary objectives are to describe the safety patterns of docetaxel use among mCRPC patients who received chemotherapy post radium-223.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ra-223 therapy before chemotherapy | – | Drug: Xofigo, Drug: Taxotere, Drug: JevtanaTreatment sequence 1 will include all mCRPC patients who received Ra-223 alone or in combination with abiraterone or enzalutamide and subsequently received chemotherapy |
| Ra-223 after chemotherapy | – | Drug: Xofigo, Drug: Taxotere, Drug: JevtanaTreatment sequence 2 includes all mCRPC patients who received chemotherapy before Radium 223 therapy |
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 be comprised of patients with CRPC and bone metastasis who have received at least one dose of radium-223 at one of the participating cancer centers. The participating centers are 4 tertiary care cancer centers (Dana Farber Cancer Institute, Tulane Cancer Center, Memorial Sloan Kettering Cancer Center and Beth Israel Deaconess Medical Center)
Key inclusion criteria (2 listed)
- Received at least one dose of radium-223 after mCRPC diagnosis
- Received at least one prescription or dose of chemotherapy for treatment of mCRPC
Key exclusion criteria (1 listed)
- No documented visceral metastasis at initiation of radium-223
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 |
|---|---|---|
| XofigoRadium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injection | Drug | Ra-223 after chemotherapy, Ra-223 therapy before chemotherapy |
| TaxotereDocetaxel injection 75mg/m2 every 3 weeks | Drug | Ra-223 after chemotherapy, Ra-223 therapy before chemotherapy |
| JevtanaCabazitaxel injection 25mg/m2 intravenously once every 3 weeks | Drug | Ra-223 after chemotherapy, Ra-223 therapy before chemotherapy |
Primary outcome
Overall survival
Time frame: Up to 30 months
Survival will be measured from initiation of first line therapy after mCRPC diagnosis until the date of death (from any cause).
Time to symtomatic skeletal event(SSE)
Time frame: Up to 30 months
Measured as the time from initiation of first-line therapy after mCRPC diagnosis until first SSE; for the exploratory analysis, measured as the time from initiation of radium-223 until first SSE. SSE will be identified based on the ALSYMPCA trial definition: first use of external-beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic vertebral or non-vertebral bone fractures, spinal cord compression, or tumor-related orthopedic surgical intervention
Reasons for treatment discontinuation
Time frame: Up to 30 months
data for treatment discontinuation for each mCRPC therapy will be collected
6 secondary outcomes
Laboratory-based outcomes collected by questionnaire
Time frame: Up to 30 months
Treatments received
Time frame: Up to 30 months
Number of hospitalizations
Time frame: Up to 30 months
PSA PFS
Time frame: Up to 30 months
Non-laboratory based clinically relevant safety outcomes
Time frame: Up to 30 months
hospital length of stay
Time frame: Up to 30 months
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 22 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Prostate Cancer, Castration Resistant, run by Bayer at 1 site in United States.
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 22 Oct 2020. 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 United States. 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?
Overall survival (time frame: Up to 30 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2020.