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).

NCT03896984 | Completed

• 1 other identifier: 20526
• Study Type: observational
• Target: 346
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Descriptive analysis of patient demography at baseline

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

• Descriptive analysis of clinical characteristics of patients at baseline

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

• Descriptive analysis of laboratory values at baseline

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

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

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

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

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

Study Arms (2)

Cohort_2LX

Patients 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

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

Cohort_2LH

Patients 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

Drug: Abiraterone; Drug: Enzalutamide

Interventions

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.

Cohort_2LX

Abiraterone DRUG

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.

Cohort_2LH; Cohort_2LX

Enzalutamide DRUG

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.

Cohort_2LH; Cohort_2LX

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

US Flatiron prostate cancer database

Whippany, New Jersey, 07981, United States

Location

Related Publications (1)

• 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.

  PMID: 34636627 RESULT

Related Links

• Click here to find results for studies related to Bayer products.

MeSH Terms

Interventions

Radium-223; radium Ra 223 dichloride; abiraterone; enzalutamide

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 1, 2019
• Study Start: March 18, 2019
• Primary Completion: June 8, 2020
• Study Completion: December 14, 2020
• Last Updated: December 29, 2021

Record last verified: 2021-12

Locations

US (1)