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

Sponsor

Azienda Ospedaliero-Universitaria Careggi (Other)

Overall Status

Completed

CT.gov ID

NCT05471427

Collaborator

(none)

118

Enrollment

Location

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Elderly Patients Metastatic Prostate Cancer	Drug: Taxane chemotherapy

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 Design

Study Type:

Observational

Actual Enrollment :

118 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Jul 1, 2022

Actual Study Completion Date :

Jul 1, 2022

Outcome Measures

Primary Outcome Measures

Treatment interruption [10 months]
Number of participants with definitive treatment stop unrelated to treatment progression

Secondary Outcome Measures

Treatment suspension [10 months]
Number of participants with temporary treatment stop related to adverse event

Other Outcome Measures

Dose reduction [10 months]
Number of participants with dose schedule modification related to adverse event

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Careggi Radiation Oncology Unit	Florence		Italy	50134

Sponsors and Collaborators

Azienda Ospedaliero-Universitaria Careggi

Investigators

Principal Investigator: Lorenzo LL Livi, Azienda Ospedaliero-Universitaria Careggi

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Lorenzo Livi, Full Professor, Azienda Ospedaliero-Universitaria Careggi

ClinicalTrials.gov Identifier:

NCT05471427

Other Study ID Numbers:

ANCHISES

First Posted:

Jul 22, 2022

Last Update Posted:

Jul 22, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prostatic Neoplasms

Docetaxel

Taxane

Study Results

No Results Posted as of Jul 22, 2022