An observational study in Prostatic Neoplasms, Castration-Resistant, sponsored by Bayer. Withdrawn. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2018-10-31.
Sponsored by Bayer · Observational
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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.
85 studies on the registry are indexed under Prostatic Neoplasms, Castration-Resistant; 28 are open to participants now.
Browse Prostatic Neoplasms, Castration-Resistant studies →Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Time frame: Up to 1 year
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
Time frame: Up to 1 year
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
Time frame: Up to 1 year
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
Time frame: Up to 1 year
Time to death
Time frame: Up to 1 year
Sequence of treatment regimens
Time frame: Up to 1 year
Dose schedule
Time frame: Up to 1 year
Duration of therapy
Time frame: Up to 1 year
Time to first visceral metastasis
Time frame: Up to 1 year
Proportion of patients developing visceral metastasis
Time frame: Up to 1 year
No study locations are listed for this record.
Start is estimated for Oct 2017; primary completion for Sep 2018, 10 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Prostatic Neoplasms, Castration-Resistant →