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Clinical Trials/NCT05471427
NCT05471427
Completed
Not Applicable

Predictive fActors for toleraNce to Taxane Based CHemotherapy In Older adultS Affected by mEtastatic Prostate Cancer, a Prospective Observational Study (ANCHISES)

Azienda Ospedaliero-Universitaria Careggi1 site in 1 country118 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Elderly Patients
Sponsor
Azienda Ospedaliero-Universitaria Careggi
Enrollment
118
Locations
1
Primary Endpoint
Treatment interruption
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
July 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lorenzo Livi

Full Professor

Azienda Ospedaliero-Universitaria Careggi

Eligibility Criteria

Inclusion Criteria

  • Patients affected by metastatic prostate cancer
  • \>/=70 years old.
  • Patients undergoing Taxane treatment with Docetaxel or Cabazitaxel
  • Exclusion criteria:
  • Patients younger than 70 years old.
  • Patients unsuitable for taxane chemotherapy

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Treatment interruption

Time Frame: 10 months

Number of participants with definitive treatment stop unrelated to treatment progression

Secondary Outcomes

  • Treatment suspension(10 months)

Study Sites (1)

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