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Metastatic Castration-resistant Prostate Cancer (mCRPC)PHENIXNCT03896984

Descriptive Analysis of Clinical Outcomes in Patients With Prostate Gland Cancer, Which Spreads to Other Parts of the Body, Who Were Treated First With Novel Anti-hormone Therapy Followed by a Second Line Treatment With Novel Anti-Hormone Therapy or RadIum-223 (Xofigo).

An observational study of Metastatic Castration-resistant Prostate Cancer (mCRPC), run by Bayer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study researcher want to learn more about the overall survival in patients suffering from prostate gland cancer which spread outside the prostate to other parts of the body who received either a novel anti-hormone therapy (NAH) or Radium-223 (Xofigo) after a prior NAH therapy (first line treatment). Read more about this study

Who is it for?
Any age, men only
What is being tested?
Radium-223 (Xofigo, BAY88-8223), Abiraterone and Enzalutamide
How many people
346 participants
Where
1 siteUnited States
Study dates
18 Mar 2019to 14 Dec 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 Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The primary study population consists of patients with documented mCRPC who either received Ra-223 or sequential NAH therapy after 1L NAH therapy respectively.

Who may be able to join

  • Patients with documented mCRPC receiving 1L NAHs.
  • Initiation of Ra-223 after 1L NAH therapy, or
  • Initiation of sequential NAH therapy after 1L NAH therapy

Who cannot join

  • Patients involved in clinical trials
  • Patients who received combined therapies in 1L or 2L

Trial locations and contacts

1 site in 1 country.

United States1 site

  • US Flatiron prostate cancer database

    Whippany, New Jersey, 07981

Other trials in United States

About this study

Official title: DescriPtive Analysis of Real-world Clinical Outcomes of Second Line (2L) Novel Anti-HormonE Therapy (NAH) or RadIum-223 (Xofigo) in Patients With Metastatic Castration Resistance Prostate Cancer (mCRPC) After First Line (1L) NAH Therapy

In this study researcher want to learn more about the overall survival in patients suffering from prostate gland cancer which spread outside the prostate to other parts of the body who received either a novel anti-hormone therapy (NAH) or Radium-223 (Xofigo) after a prior NAH therapy (first line treatment). Additionally the researchers are also interested in the occurrence of bone fractures and other skeletal events. Basis for this study will be the US based Flatiron database which provides access to clinical data for cancer patients.

Being tested
Radium-223 (Xofigo, BAY88-8223), Abiraterone, Enzalutamide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radium-223 (Xofigo, BAY88-8223)Drug

    Ra-223 was approved by the FDA in May 2013 for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

  • AbirateroneDrug

    Abiraterone is a CYP17 inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2011, and for patients with metastatic high-risk castration-sensitive prostate cancer in 2018.

  • EnzalutamideDrug

    Enzalutamide is an androgen receptor inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2012, with warning and precautions added in 2017 regarding the risk of seizure and encephalopathy.

Study groups in NCT03896984
Study groupRoleWhat they receive
Cohort_2LXPatients with mCRPC who received NAH monotherapy (Abiraterone or Enzalutamide) as first liine (1L) after diagnosis of mCRPC who then received Ra-223 monotherapy as second line (2L) treatment
Receives: Drug: Radium-223 (Xofigo, BAY88-8223); Drug: Abiraterone; Drug: Enzalutamide
Cohort_2LHPatients with mCRPC who received NAH monotherapy (Abiraterone or Enzalutamide) as 1L after diagnosis of mCRPC who then received another NAH monotherapy (i.e., Abiraterone to Enzalutamide or Enzalutamide to Abiraterone) as 2L treatment. None of the patients had ever received Radium-223 dichloride
Receives: Drug: Abiraterone; Drug: Enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS) from initiation of 2L therapy of Radium-223 in patients with mCRPC after 1L NAH therapy

    Measured: Retrospective analysis from 2013-01-01 to 2018-12-30

  2. Overall survival (OS) from initiation of 2L therapy of sequential NAH in patients with mCRPC after 1L NAH therapy

    Measured: Retrospective analysis from 2013-01-01 to 2018-12-30

Secondary outcomes (8)

  1. Descriptive analysis of patient demography at baseline

    Demographic characteristics includes:

    • Gender (expecting 100% male)
    • Age (in the year of index date)
    • Ethnicity

    Measured: Retrospective analysis from 2013-01-01 to 2018-12-30

  2. Descriptive analysis of clinical characteristics of patients at baseline

    Clinical characteristics includes:

    • Histology
    • Gleason score
    • Clinical stage (at initial diagnosis)
    • T/N/M stage (at initial diagnosis)
    • ECOG performance status
    • Site of metastasis (visceral, lymph node, bone)

    Measured: Retrospective analysis from 2013-01-01 to 2018-12-30

  3. Descriptive analysis of laboratory values at baseline

    The laboratory tests of interest includes:

    • Prostate Specific Antigen(PSA)
    • Alkaline Phosphatase(ALP)
    • Hemoglobin (Hgb)
    • Lactate dehydrogenase (LDH)

    Measured: Retrospective analysis from 2013-01-01 to 2018-12-30

  4. Frequency of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2L

    SSE:Symptomatic skeletal event

    Measured: Retrospective analysis from 2013-01-01 to 2018-12-30

  5. Incidence rate of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2L

    Measured: Retrospective analysis from 2013-01-01 to 2018-12-30

  6. Frequency of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L

    Measured: Retrospective analysis from 2013-01-01 to 2018-12-30

  7. Incidence rate of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L

    Measured: Retrospective analysis from 2013-01-01 to 2018-12-30

  8. Period of time from initiation of 2L to first SSE

    Measured: Retrospective analysis from 2013-01-01 to 2018-12-30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2019
  2. Study start18 Mar 2019
  3. Primary completion8 Jun 2020
  4. Study completion14 Dec 2020

Resources

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
346 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03896984
Sponsor's protocol ID
20526
Acronym
PHENIX
Status last verified
Dec 2021
First submitted
28 Mar 2019
Last updated
29 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Publications

  • Sartor O, George D, Tombal B, Agarwal N, Higano CS, Sternberg CN, Miller K, Jiao X, Guo H, Sandstrom P, Bruno A, Verholen F, Saad F, Shore N. Real-world outcomes of second novel hormonal therapy or radium-223 following first novel hormonal therapy for mCRPC. Future Oncol. 2022 Jan;18(1):35-45. doi: 10.2217/fon-2021-0886. Epub 2021 Oct 12.

    PubMed 34636627

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Castration-resistant Prostate Cancer (mCRPC), 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 3 inclusion and 2 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 29 Dec 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 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 (OS) from initiation of 2L therapy of Radium-223 in patients with mCRPC after 1L NAH therapy (time frame: Retrospective analysis from 2013-01-01 to 2018-12-30). The study lists 2 primary outcomes in all. 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 NCT03896984, 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 29 Dec 2021.

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