Weekly cabazitaxel chemotherapy in elderly patients with advanced prostate cancer resistant to previous docetaxel treatment

Weekly cabazitaxel in elderly MCRPC (Metastatic Castration Resistant Prostate Cancer) patients progressing after docetaxel treatment: a phase II study - WeCabE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001647-20-IT

Enrollment

Registered

2014-09-16

Start date

2014-11-18

Completion date

Unknown

Last updated

2025-02-24

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

Conditions

Castration resistant metastatic prostate cancer progressing after docetaxel based treatment MedDRA version: 17.0 Level: PT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Jevtana Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: •Metastatic castration-resistant disease with documented clinical (imaging) and/or biochemical progression (PSA increasing* values) during or after a previous docetaxel-based chemotherapy; •Testosterone level within castration range (levels =65 years) yes F.1.3.1 Number of subjects for this age range 62

Exclusion criteria

Exclusion criteria: •Age = 85; •G8 score 14 •Ventricular injection fraction 2

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoints are: biochemical Response (defined as a reduction from baseline PSA level of at least 50%, maintained for at least 3 weeks); ORR by Recist criteria V1.1; overall survival (OS); close monitoring of toxicity using the NCICTC- AE version 4.03; evaluation of geriatric assessment using the Minimal Data Set (MDS) according to the Elderly Task Force (ETF) EORTC: - Charlson comorbidity index; - G8 geriatric assessment screening tool; - Instrumental activities of daily living (IADL); - Social situation. ;Timepoint(s) of evaluation of this end point: Biochemical Response (every 10 weeks/2 cycles); ORR by Recist criteria (every 15 weeks); overall survival (OS); close monitoring of toxicity using the NCICTC- AE version 4.03; evaluation of geriatric assessment (baseline, during treatment, end of treatment) using the Minimal Data Set (MDS) according to the Elderly Task Force (ETF) EORTC: - Charlson comorbidity index; - G8 geriatric assessment screening tool; - Instrumental activities of daily living (IADL); - Social situation.	—

Measure

Time frame

Secondary end point(s): The secondary endpoints are: biochemical Response (defined as a reduction from baseline PSA level of at least 50%, maintained for at least 3 weeks); ORR by Recist criteria V1.1; overall survival (OS); close monitoring of toxicity using the NCICTC- AE version 4.03; evaluation of geriatric assessment using the Minimal Data Set (MDS) according to the Elderly Task Force (ETF) EORTC: - Charlson comorbidity index; - G8 geriatric assessment screening tool; - Instrumental activities of daily living (IADL); - Social situation. ;Timepoint(s) of evaluation of this end point: Biochemical Response (every 10 weeks/2 cycles); ORR by Recist criteria (every 15 weeks); overall survival (OS); close monitoring of toxicity using the NCICTC- AE version 4.03; evaluation of geriatric assessment (baseline, during treatment, end of treatment) using the Minimal Data Set (MDS) according to the Elderly Task Force (ETF) EORTC: - Charlson comorbidity index; - G8 geriatric assessment screening tool; - Instrumental activities of daily living (IADL); - Social situation.

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Primary

Measure	Time frame
Main Objective: The primary objective of the trial is to evaluate the activity of cabazitaxel in terms of improvement of progression free survival (PFS, defined as a composite endpoint) after 3 months of treatment in elderly patients progressing after a previous docetaxel-based chemotherapy;Secondary Objective: Secondary objectives are: biochemical response, overall survival (OS), treatment toxicity and geriatric assessment;Primary end point(s): The primary endpoint is a composite progression free survival (PFS) endpoint defined as the occurrence of any of the following events: tumor progression based on RECIST criteria; bone progression when 2 or more new lesions; pain progression based on PPI test; death from of any cause. ;Timepoint(s) of evaluation of this end point: - Baseline - Every 3 cycles (15 weeks) - At the end of the treatment - During the follow-up phase every 3 months	—

Measure

Time frame

Main Objective: The primary objective of the trial is to evaluate the activity of cabazitaxel in terms of improvement of progression free survival (PFS, defined as a composite endpoint) after 3 months of treatment in elderly patients progressing after a previous docetaxel-based chemotherapy;Secondary Objective: Secondary objectives are: biochemical response, overall survival (OS), treatment toxicity and geriatric assessment;Primary end point(s): The primary endpoint is a composite progression free survival (PFS) endpoint defined as the occurrence of any of the following events: tumor progression based on RECIST criteria; bone progression when 2 or more new lesions; pain progression based on PPI test; death from of any cause. ;Timepoint(s) of evaluation of this end point: - Baseline - Every 3 cycles (15 weeks) - At the end of the treatment - During the follow-up phase every 3 months

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Countries

Italy

Contacts

Public ContactSOS Oncologia

Ospedale San Giacomo Novi Ligure

oncologia.novi@aslal.it+390143332421

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026