Predictive fActors for toleraNce to Taxane Based CHemotherapy In Older adultS Affected by mEtastatic Prostate Cancer

Completed

• Conditions: Metastatic Prostate Cancer; Elderly Patients

• Registration Number: NCT05471427
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

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.

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2022-07
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Study First Submitted: 2022-07-08
• Study First Submitted QC: 2022-07-21
• Last Update Submitted: 2022-07-21
• Study First Posted: 2022-07-22
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 118

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment interruption	10 months	Number of participants with definitive treatment stop unrelated to treatment progression

Secondary Outcome Measures

Name	Time	Method
Treatment suspension	10 months	Number of participants with temporary treatment stop related to adverse event

Trial Locations

Locations (1)

AOU Careggi Radiation Oncology Unit; 🇮🇹 Florence, Italy