Prostatic Neoplasms, Castration-ResistantNCT03325127
Outcomes of mCRPC Patients Treated With Ra-223 Concomitant With Abiraterone or Enzalutamide- A Chart Review Study
An observational study of Prostatic Neoplasms, Castration-Resistant, run by Bayer.
Trial summary
There are no real-world data that describes how Radium-223 (Ra-223) is being used in combination with abiraterone/enzalutamide (abi/enza) or evidence describing outcomes of this combination usage for the treatment of metastatic castration resistant prostate cancer (mCRPC). Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Castration-Resistant
- What is being tested?
- radium Ra 223 dichloride (Xofigo, BAY88-8223), Zytiga and Xtandi
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2017to 28 Sep 2018
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be identified by their treating physicians (oncologists and urologists), who will be recruited for participation in the research from the Cardinal Health Oncology Research Network (CHORN).
Who may be able to join
- Diagnosis of mCRPC and bone metastases
- ≥ 40 years of age at diagnosis of mCRPC
- Initiated first line treatment for mCRPC with abi/enza (use of sipuleucel-T prior to initiation of abi or enza is allowed)
- Receipt of at least one cycle of radium-223 after 15 May 2013
- First cycle of Ra-223 occurs while receiving first line treatment with abi/enza
- Treated with abi/enza for at least 28 days (1 cycle) following initiation of Ra-223
Show all 10Show fewer
- Initiation of Ra-223 at least 6 months after the start of treatment with abi/enza
- Completion of Ra-223 treatment prior to the receipt of any chemotherapy for mCRPC
- At least 12 months of follow-up (or until death) from date of initiation of Ra-223
- Known date of death (if patient deceased)
Who cannot join
- Receipt of any prior chemotherapy during hormone sensitive disease or any time before mCPRC
- Active participant in an interventional clinical trial for CRPC in first line
- Presence of visceral metastases at initiation of Ra-223 treatment
- Treated with abi/enza (with or without docetaxel) prior to the development of metastatic and/or castration resistant disease
About this study
Official title: Outcomes and Treatment Patterns of Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients Treated With Radium-223 Concomitantly With Abiraterone or Enzalutamide in First Line Setting : A Retrospective Chart Abstraction Study
There are no real-world data that describes how Radium-223 (Ra-223) is being used in combination with abiraterone/enzalutamide (abi/enza) or evidence describing outcomes of this combination usage for the treatment of metastatic castration resistant prostate cancer (mCRPC). To address these data gaps a cohort of mCRPC patients will be chosen who received Ra-223 concomitant with abi/enza in first line therapy to assess the treatment patterns following first line and clinical outcomes from initiation of first line treatment. For the purpose of this study concomitant use will be defined as Ra-223 initiated after at least 6 months from the start of first line abi/enza. The specific objectives of the study are to describe the outcomes, treatment patterns, patient and provider characteristics of mCRPC patients treated with Ra-223 concomittantly with abi/enza in first line treatment.
- Being tested
- radium Ra 223 dichloride (Xofigo, BAY88-8223), Zytiga, Xtandi
- Keywords
- Prostate Cancer, Bone metastases, Xofigo, Zytiga, Xtandi.
- Medical subject headings
- Prostatic Neoplasms, Castration-Resistant, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radium Ra 223 dichloride (Xofigo, BAY88-8223)Drug
Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injections
ZytigaDrug
Abiraterone 1000 mg per day orally
XtandiDrug
Enzalutamide 160 mg per day orally
| Study group | Role | What they receive |
|---|---|---|
| Radium-223 concomitant with Abiraterone or Enzalutamide | Approximately 150 medical charts from mCRPC patients within the network will be collected Receives: Drug: radium Ra 223 dichloride (Xofigo, BAY88-8223); Drug: Zytiga; Drug: Xtandi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rates
Survival will be defined as time from initiation of first line therapy until death. Survival will be measured as the proportion of study subjects that are alive at the data cut-off or median time for survival of at least 50% of study subjects
Measured: Up to 1 year
Secondary outcomes (9)
Disease progression
Disease progression will be defined as either of the below:
PSA (Prostate Specific Antigen) progression ALP (Alkaline Phosphatase) progression Symptomatic progression Radiographic progression
Measured: Up to 1 year
Skeletal related events (SRE)
SRE will be defined as: a pathologic fracture, spinal cord compression, necessity for radiation to bone for pain or impending fracture and/or surgery to bone
Measured: Up to 1 year
Symptomatic Skeletal Events (SSE)
SSE defined as external beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic bone fracture, occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention
Measured: Up to 1 year
Time to death
Measured: Up to 1 year
Sequence of treatment regimens
Measured: Up to 1 year
Dose schedule
Measured: Up to 1 year
Duration of therapy
Measured: Up to 1 year
Time to first visceral metastasis
Measured: Up to 1 year
Proportion of patients developing visceral metastasis
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start30 Oct 2017 (estimated)
- Primary completion28 Sep 2018 (estimated)
- Study completion28 Sep 2018 (estimated)
Why it stopped: Project plan changed, study conduct was no longer needed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic Neoplasms, 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325127
- Sponsor's protocol ID
- 19706
- Status last verified
- Oct 2018
- First submitted
- 20 Oct 2017
- Last updated
- 31 Oct 2018
- 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 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes and Treatment Patterns of Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients Treated With Radium-223 Concomitantly With Abiraterone or Enzalutamide in First Line Setting : A Retrospective Chart Abstraction Study
- ClinicalTrials.gov ID
- NCT03325127
- Acronym / sponsor ID
- 19706
- Keywords
- Prostate Cancer, Bone metastases, Xofigo, Zytiga, Xtandi.
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Project plan changed, study conduct was no longer needed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2017 (estimated)
- Primary completion
- 28 Sep 2018 (estimated)
- Study completion
- 28 Sep 2018 (estimated)
- First posted
- 30 Oct 2017 (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.
There are no real-world data that describes how Radium-223 (Ra-223) is being used in combination with abiraterone/enzalutamide (abi/enza) or evidence describing outcomes of this combination usage for the treatment of metastatic castration resistant prostate cancer (mCRPC). To address these data gaps a cohort of mCRPC patients will be chosen who received Ra-223 concomitant with abi/enza in first line therapy to assess the treatment patterns following first line and clinical outcomes from initiation of first line treatment. For the purpose of this study concomitant use will be defined as Ra-223 initiated after at least 6 months from the start of first line abi/enza. The specific objectives of the study are to describe the outcomes, treatment patterns, patient and provider characteristics of mCRPC patients treated with Ra-223 concomittantly with abi/enza in first line treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radium-223 concomitant with Abiraterone or Enzalutamide | – | Drug: radium Ra 223 dichloride (Xofigo, BAY88-8223), Drug: Zytiga, Drug: XtandiApproximately 150 medical charts from mCRPC patients within the network will be collected |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be identified by their treating physicians (oncologists and urologists), who will be recruited for participation in the research from the Cardinal Health Oncology Research Network (CHORN).
Key inclusion criteria (10 listed)
- Diagnosis of mCRPC and bone metastases
- ≥ 40 years of age at diagnosis of mCRPC
- Initiated first line treatment for mCRPC with abi/enza (use of sipuleucel-T prior to initiation of abi or enza is allowed)
- Receipt of at least one cycle of radium-223 after 15 May 2013
- First cycle of Ra-223 occurs while receiving first line treatment with abi/enza
Key exclusion criteria (4 listed)
- Receipt of any prior chemotherapy during hormone sensitive disease or any time before mCPRC
- Active participant in an interventional clinical trial for CRPC in first line
- Presence of visceral metastases at initiation of Ra-223 treatment
- Treated with abi/enza (with or without docetaxel) prior to the development of metastatic and/or castration resistant disease
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 Ra 223 dichloride (Xofigo, BAY88-8223)Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injections | Drug | Radium-223 concomitant with Abiraterone or Enzalutamide |
| ZytigaAbiraterone 1000 mg per day orally | Drug | Radium-223 concomitant with Abiraterone or Enzalutamide |
| XtandiEnzalutamide 160 mg per day orally | Drug | Radium-223 concomitant with Abiraterone or Enzalutamide |
Primary outcome
Survival rates
Time frame: Up to 1 year
Survival will be defined as time from initiation of first line therapy until death. Survival will be measured as the proportion of study subjects that are alive at the data cut-off or median time for survival of at least 50% of study subjects
9 secondary outcomes
Disease progression
Time frame: Up to 1 year
Skeletal related events (SRE)
Time frame: Up to 1 year
Symptomatic Skeletal Events (SSE)
Time frame: Up to 1 year
Time to death
Time frame: Up to 1 year
Sequence of treatment regimens
Time frame: Up to 1 year
Dose schedule
Time frame: Up to 1 year
Duration of therapy
Time frame: Up to 1 year
Time to first visceral metastasis
Time frame: Up to 1 year
Proportion of patients developing visceral metastasis
Time frame: Up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
Related trials for Prostatic Neoplasms, Castration-Resistant
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Active, not recruitingPhase 2
Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Prostate Cancer
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms, Castration-Resistant, run by Bayer.
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 10 inclusion and 4 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: withdrawn, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Survival rates (time frame: Up to 1 year). 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 31 Oct 2018.