Multi-academic Center Study of Xofigo Patients

NCT03419442 | Completed

• 1 other identifier: 19863
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer, Castration Resistant

Keywords

Prostate cancer; Bone metastases; Xofigo

Outcome Measures

Primary Outcomes (3)

• Overall survival

  Survival will be measured from initiation of first line therapy after mCRPC diagnosis until the date of death (from any cause).

  Up to 30 months

• Time to symtomatic skeletal event(SSE)

  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

  Up to 30 months

• Reasons for treatment discontinuation

  data for treatment discontinuation for each mCRPC therapy will be collected

  Up to 30 months

Secondary Outcomes (6)

• Laboratory-based outcomes collected by questionnaire

  Up to 30 months

• Treatments received

  Up to 30 months

• Number of hospitalizations

  Up to 30 months

• PSA PFS

  Up to 30 months

• Non-laboratory based clinically relevant safety outcomes

  Up to 30 months

Study Arms (2)

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; Drug: Taxotere; Drug: Jevtana

Ra-223 after chemotherapy

Treatment sequence 2 includes all mCRPC patients who received chemotherapy before Radium 223 therapy

Drug: Xofigo; Drug: Taxotere; Drug: Jevtana

Interventions

Xofigo DRUG

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

Ra-223 after chemotherapy; Ra-223 therapy before chemotherapy

Taxotere DRUG

Docetaxel injection 75mg/m2 every 3 weeks

Ra-223 after chemotherapy; Ra-223 therapy before chemotherapy

Jevtana DRUG

Cabazitaxel injection 25mg/m2 intravenously once every 3 weeks

Ra-223 after chemotherapy; Ra-223 therapy before chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• \- No documented visceral metastasis at initiation of radium-223

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Bayer US

Whippany, New Jersey, 07981, United States

Location

Related Links

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

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

radium Ra 223 dichloride; Docetaxel; cabazitaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

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

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: February 5, 2018
• Study Start: December 3, 2018
• Primary Completion: October 22, 2019
• Study Completion: October 22, 2019
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

US (1)