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OpenTrials
Completed

NCT Number: NCT05471427

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

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.

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Key information

Age range

70 year and older

Sex eligibility

Male

Study type

Observational

Primary location

AOU Careggi Radiation Oncology Unit

Florence, 50134, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Taxane Chemotherapy

Drug

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

Other names: Docetaxel or Cabazitaxel

Primary outcomes

  1. Treatment interruption

    Time frame: 10 months

    Number of participants with definitive treatment stop unrelated to treatment progression

Secondary outcomes

  1. Treatment suspension

    Time frame: 10 months

    Number of participants with temporary treatment stop related to adverse event

Other outcomes

  1. Dose reduction

    Time frame: 10 months

    Number of participants with dose schedule modification related to adverse event

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Careggi

Other

Registry information

Official study title

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

Acronym: ANCHISES

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2022
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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