An observational study in Elderly Patients and Metastatic Prostate Cancer, sponsored by Azienda Ospedaliero-Universitaria Careggi. Completed at 1 site in Italy. Open to male participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2022-07-22.
Sponsored by Azienda Ospedaliero-Universitaria Careggi · Observational
Aiming to explore predictive factors of fitness to taxane chemotherapy in elderly patients, the investigators collected data from a prospective mono-centric database of patients aged >/= 70 years old treated in our department, and explored association between baseline age, G8 score and Charlson comorbidity index with taxane dose reduction, treatment temporary suspension or definitive interruption.
Patients included in the analysis were affected by metastatic prostate cancer with >/=70 years old. All patients underwent Taxane treatment starting with standard treatment schedules (75 mg/m2 or 25 mg/m2 every 3 weeks, respectively). Chemotherapy with Docetaxel was scheduled for a total of 6-8 cicles in the mHSPC-mCRPC setting, respectively, and up to 9 cycles for Cabazitaxel treatment.
Indication to taxane chemotherapy was based on treating physician choice. G8 Questionnaires were collected before start and at the end of chemotherapy. Charlson comorbidity index was recorded for all patients before chemotherapy start. Data comprehensive of age, castrate resistant status , type of taxane used , Growth factors use during treatment, previous and following treatment with ARTAs or other taxanes, number of cycles administered, dose reductions , treatment suspension and treatment definitive interruptions unrelated to progressive disease, were collected and reported. Logistic regression was performed to explore the association between outcomes and baseline age, CCI and G8 score. Receiver Operating Characteristic curves analysis was performed to look for the optimal cut-off value for features significantly associated with treatment outcomes.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 118 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Azienda Ospedaliero-Universitaria Careggi is the lead sponsor of 75 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients affected by metastatic prostate cancer (either in castrate resistant or hormone sensitive status), undergoing taxane chemotherapy in any setting at an age >/=70 years old
Patients affected by metastatic prostate cancer
->/=70 years old.
Exclusion criteria:
Patients underwent taxane chemotherapy according to clinical practice for metastatic prostate cancer
Also known as: Docetaxel or Cabazitaxel
Treatment interruption
Number of participants with definitive treatment stop unrelated to treatment progression
Time frame: 10 months
Treatment suspension
Number of participants with temporary treatment stop related to adverse event
Time frame: 10 months
Dose reduction
Number of participants with dose schedule modification related to adverse event
Time frame: 10 months
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliero-Universitaria Careggi