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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05471427
Acronym
ANCHISES
Enrollment
118
Registered
2022-07-22
Start date
2020-01-01
Completion date
2022-07-01
Last updated
2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly Patients, Metastatic Prostate Cancer

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.

Interventions

Patients underwent taxane chemotherapy according to clinical practice for metastatic prostate cancer

Sponsors

Azienda Ospedaliero-Universitaria Careggi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment interruption10 monthsNumber of participants with definitive treatment stop unrelated to treatment progression

Secondary

MeasureTime frameDescription
Treatment suspension10 monthsNumber of participants with temporary treatment stop related to adverse event

Other

MeasureTime frameDescription
Dose reduction10 monthsNumber of participants with dose schedule modification related to adverse event

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026