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).

Metastatic Castration-resistant Prostate Cancer (mCRPC) Clinical Trial

— PHENIX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03896984
• Other study ID #: 20526
• Status: Completed
• Start date: March 18, 2019
• Est. completion date: December 14, 2020

Study information

• Verified date: December 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: December 14, 2020
• Est. primary completion date: June 8, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion criteria:

• Patients involved in clinical trials

• Patients who received combined therapies in 1L or 2L

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer (mCRPC)
• Prostatic Neoplasms

Intervention

Drug:
• Radium-223 (Xofigo, BAY88-8223)
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.
• Abiraterone
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.
• Enzalutamide
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.

Locations

Country	Name	City	State
United States	US Flatiron prostate cancer database	Whippany	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sartor O, George D, Tombal B, Agarwal N, Higano CS, Sternberg CN, Miller K, Jiao X, Guo H, Sandström 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 mCR — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS) from initiation of 2L therapy of Radium-223 in patients with mCRPC after 1L NAH therapy		Retrospective analysis from 2013-01-01 to 2018-12-30
Primary	Overall survival (OS) from initiation of 2L therapy of sequential NAH in patients with mCRPC after 1L NAH therapy		Retrospective analysis from 2013-01-01 to 2018-12-30
Secondary	Descriptive analysis of patient demography at baseline	Demographic characteristics includes: Gender (expecting 100% male); Age (in the year of index date); Ethnicity	Retrospective analysis from 2013-01-01 to 2018-12-30
Secondary	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)	Retrospective analysis from 2013-01-01 to 2018-12-30
Secondary	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)	Retrospective analysis from 2013-01-01 to 2018-12-30
Secondary	Frequency of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2L	SSE:Symptomatic skeletal event	Retrospective analysis from 2013-01-01 to 2018-12-30
Secondary	Incidence rate of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2L		Retrospective analysis from 2013-01-01 to 2018-12-30
Secondary	Frequency of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L		Retrospective analysis from 2013-01-01 to 2018-12-30
Secondary	Incidence rate of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L		Retrospective analysis from 2013-01-01 to 2018-12-30
Secondary	Period of time from initiation of 2L to first SSE		Retrospective analysis from 2013-01-01 to 2018-12-30

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