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

Metastatic Prostate Cancer Clinical Trial

— ANCHISES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05471427
• Other study ID #: ANCHISES
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elderly Patients
• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Taxane chemotherapy
Patients underwent taxane chemotherapy according to clinical practice for metastatic prostate cancer

Locations

Country	Name	City	State
Italy	AOU Careggi Radiation Oncology Unit	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

References & Publications (19)

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dose reduction	Number of participants with dose schedule modification related to adverse event	10 months
Primary	Treatment interruption	Number of participants with definitive treatment stop unrelated to treatment progression	10 months
Secondary	Treatment suspension	Number of participants with temporary treatment stop related to adverse event	10 months