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

NCT03325127 | Withdrawn

• 1 other identifier: 19706
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostatic Neoplasms, Castration-Resistant

Keywords

Prostate Cancer, Bone metastases, Xofigo, Zytiga, Xtandi.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Disease progression

  Up to 1 year

• Skeletal related events (SRE)

  Up to 1 year

• Symptomatic Skeletal Events (SSE)

  Up to 1 year

• Time to death

  Up to 1 year

• Sequence of treatment regimens

  Up to 1 year

Study Arms (1)

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); Drug: Zytiga; Drug: Xtandi

Interventions

radium Ra 223 dichloride (Xofigo, BAY88-8223) DRUG

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

Radium-223 concomitant with Abiraterone or Enzalutamide

Zytiga DRUG

Abiraterone 1000 mg per day orally

Radium-223 concomitant with Abiraterone or Enzalutamide

Xtandi DRUG

Enzalutamide 160 mg per day orally

Radium-223 concomitant with Abiraterone or Enzalutamide

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be identified by their treating physicians (oncologists and urologists), who will be recruited for participation in the research from the Cardinal Health Oncology Research Network (CHORN).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant; Prostatic Neoplasms

Interventions

radium Ra 223 dichloride; Abiraterone Acetate; enzalutamide

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)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 30, 2017
• Study Start: October 30, 2017
• Primary Completion: September 28, 2018
• Study Completion: September 28, 2018
• Last Updated: October 31, 2018

Record last verified: 2018-10