Outcomes of mCRPC Patients Treated With Ra-223 Concomitant With Abiraterone or Enzalutamide- A Chart Review Study

Prostatic Neoplasms, Castration-Resistant Clinical Trial

Official title:

Outcomes and Treatment Patterns of Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients Treated With Radium-223 Concomitantly With Abiraterone or Enzalutamide in First Line Setting : A Retrospective Chart Abstraction Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03325127
• Other study ID #: 19706
• Status: Withdrawn
• Start date: October 30, 2017
• Est. completion date: September 28, 2018

Study information

• Verified date: October 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There are no real-world data that describes how Radium-223 (Ra-223) is being used in combination with abiraterone/enzalutamide (abi/enza) or evidence describing outcomes of this combination usage for the treatment of metastatic castration resistant prostate cancer (mCRPC). To address these data gaps a cohort of mCRPC patients will be chosen who received Ra-223 concomitant with abi/enza in first line therapy to assess the treatment patterns following first line and clinical outcomes from initiation of first line treatment. For the purpose of this study concomitant use will be defined as Ra-223 initiated after at least 6 months from the start of first line abi/enza. The specific objectives of the study are to describe the outcomes, treatment patterns, patient and provider characteristics of mCRPC patients treated with Ra-223 concomittantly with abi/enza in first line treatment.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 28, 2018
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of mCRPC and bone metastases

• = 40 years of age at diagnosis of mCRPC

• Initiated first line treatment for mCRPC with abi/enza (use of sipuleucel-T prior to initiation of abi or enza is allowed)

• Receipt of at least one cycle of radium-223 after 15 May 2013

• First cycle of Ra-223 occurs while receiving first line treatment with abi/enza

• Treated with abi/enza for at least 28 days (1 cycle) following initiation of Ra-223

• Initiation of Ra-223 at least 6 months after the start of treatment with abi/enza

• Completion of Ra-223 treatment prior to the receipt of any chemotherapy for mCRPC

• At least 12 months of follow-up (or until death) from date of initiation of Ra-223

• Known date of death (if patient deceased)

Exclusion Criteria:

• Receipt of any prior chemotherapy during hormone sensitive disease or any time before mCPRC

• Active participant in an interventional clinical trial for CRPC in first line

• Presence of visceral metastases at initiation of Ra-223 treatment

• Treated with abi/enza (with or without docetaxel) prior to the development of metastatic and/or castration resistant disease

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Prostatic Neoplasms, Castration-Resistant

Intervention

Drug:
• radium Ra 223 dichloride (Xofigo, BAY88-8223)
Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injections
• Zytiga
Abiraterone 1000 mg per day orally
• Xtandi
Enzalutamide 160 mg per day orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rates	Survival will be defined as time from initiation of first line therapy until death. Survival will be measured as the proportion of study subjects that are alive at the data cut-off or median time for survival of at least 50% of study subjects	Up to 1 year
Secondary	Disease progression	Disease progression will be defined as either of the below: PSA (Prostate Specific Antigen) progression ALP (Alkaline Phosphatase) progression Symptomatic progression Radiographic progression	Up to 1 year
Secondary	Skeletal related events (SRE)	SRE will be defined as: a pathologic fracture, spinal cord compression, necessity for radiation to bone for pain or impending fracture and/or surgery to bone	Up to 1 year
Secondary	Symptomatic Skeletal Events (SSE)	SSE defined as external beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic bone fracture, occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention	Up to 1 year
Secondary	Time to death		Up to 1 year
Secondary	Sequence of treatment regimens		Up to 1 year
Secondary	Dose schedule		Up to 1 year
Secondary	Duration of therapy		Up to 1 year
Secondary	Time to first visceral metastasis		Up to 1 year
Secondary	Proportion of patients developing visceral metastasis		Up to 1 year