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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03325127
Other study ID # 19706
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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