Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multi-academic Center Study of Xofigo Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03419442
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

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.


Condition or disease Intervention/treatment
Prostate Cancer, Castration Resistant Drug: Xofigo Drug: Taxotere Drug: Jevtana

Layout table for study information
Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective, Longitudinal Multi-Center Study of Radium-223 in Patients With Metastatic Castration-Resistant Prostate Cancer
Actual Study Start Date : December 3, 2018
Actual Primary Completion Date : October 22, 2019
Actual Study Completion Date : October 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Ra-223 therapy before chemotherapy
Treatment sequence 1 will include all mCRPC patients who received Ra-223 alone or in combination with abiraterone or enzalutamide and subsequently received chemotherapy
Drug: Xofigo
Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injection

Drug: Taxotere
Docetaxel injection 75mg/m2 every 3 weeks

Drug: Jevtana
Cabazitaxel injection 25mg/m2 intravenously once every 3 weeks

Ra-223 after chemotherapy
Treatment sequence 2 includes all mCRPC patients who received chemotherapy before Radium 223 therapy
Drug: Xofigo
Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injection

Drug: Taxotere
Docetaxel injection 75mg/m2 every 3 weeks

Drug: Jevtana
Cabazitaxel injection 25mg/m2 intravenously once every 3 weeks




Primary Outcome Measures :
  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 Outcome Measures :
  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. Overall survival [ Time Frame: Up to 30 months ]
    measured as the time from date of initiation of radium-223 until the date of death

  7. hospital length of stay [ Time Frame: Up to 30 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will be comprised of patients with CRPC and bone metastasis who have received at least one dose of radium-223 at one of the participating cancer centers. The participating centers are 4 tertiary care cancer centers (Dana Farber Cancer Institute, Tulane Cancer Center, Memorial Sloan Kettering Cancer Center and Beth Israel Deaconess Medical Center)
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419442


Locations
Layout table for location information
United States, New Jersey
Bayer US
Whippany, New Jersey, United States, 07981
Sponsors and Collaborators
Bayer

Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03419442    
Other Study ID Numbers: 19863
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Prostate cancer
Bone metastases
Xofigo
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Radium Ra 223 dichloride
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action