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Completed

NCT Number: NCT03419442

Multi-academic Center Study of Xofigo Patients

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.

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Key information

Conditions

Prostate Cancer, Castration Resistant Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Bayer US

Whippany, New Jersey, 07981, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Received at least one dose of radium-223 after mCRPC diagnosis
  • Received at least one prescription or dose of chemotherapy for treatment of mCRPC

Exclusion criteria

  • No documented visceral metastasis at initiation of radium-223

Treatment and study plan

Xofigo

Drug

Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injection

Taxotere

Drug

Docetaxel injection 75mg/m2 every 3 weeks

Jevtana

Drug

Cabazitaxel injection 25mg/m2 intravenously once every 3 weeks

Primary outcomes

  1. 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).

  2. 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

  3. Reasons for treatment discontinuation

    Time frame: Up to 30 months

    data for treatment discontinuation for each mCRPC therapy will be collected

Secondary outcomes

  1. Laboratory-based outcomes collected by questionnaire

    Time frame: Up to 30 months

    Data will be collected as available from initiation of docetaxel until 3 months following last dose of docetaxel

  2. Treatments received

    Time frame: Up to 30 months

    measured as Yes/No

  3. Number of hospitalizations

    Time frame: Up to 30 months

    along with the discharge diagnosis, as recorded in medical charts or discharge summaries

  4. PSA PFS

    Time frame: Up to 30 months

    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))

  5. Non-laboratory based clinically relevant safety outcomes

    Time frame: Up to 30 months

    documented in medical records

  6. hospital length of stay

    Time frame: Up to 30 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Retrospective, Longitudinal Multi-Center Study of Radium-223 in Patients With Metastatic Castration-Resistant Prostate Cancer

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2018
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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