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

• Sponsor: Bayer (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT03325127
• Collaborator: (none)
• Enrollment: 0
• Anticipated Duration (Months): 10.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms, Castration-Resistant	Drug: radium Ra 223 dichloride (Xofigo, BAY88-8223); Drug: Zytiga; Drug: Xtandi

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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
• Anticipated Study Start Date: Oct 30, 2017
• Anticipated Primary Completion Date: Sep 28, 2018
• Anticipated Study Completion Date: Sep 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
Radium-223 concomitant with Abiraterone or Enzalutamide Approximately 150 medical charts from mCRPC patients within the network will be collected	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; Drug: Zytiga; Abiraterone 1000 mg per day orally; Drug: Xtandi; Enzalutamide 160 mg per day orally

Outcome Measures

Primary Outcome Measures

1. Survival rates [Up to 1 year]

   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

Secondary Outcome Measures

1. Disease progression [Up to 1 year]

   Disease progression will be defined as either of the below: PSA (Prostate Specific Antigen) progression ALP (Alkaline Phosphatase) progression Symptomatic progression Radiographic progression

2. Skeletal related events (SRE) [Up to 1 year]

   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

3. Symptomatic Skeletal Events (SSE) [Up to 1 year]

   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

4. Time to death [Up to 1 year]

5. Sequence of treatment regimens [Up to 1 year]

6. Dose schedule [Up to 1 year]

7. Duration of therapy [Up to 1 year]

8. Time to first visceral metastasis [Up to 1 year]

9. Proportion of patients developing visceral metastasis [Up to 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03325127
• Other Study ID Numbers: 19706
• First Posted: Oct 30, 2017
• Last Update Posted: Oct 31, 2018
• Last Verified: Oct 1, 2018

• 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, Zytiga, Xtandi.
• Additional relevant MeSH terms: Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant; Radium Ra 223 dichloride

Study Results

No Results Posted as of Oct 31, 2018