Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Docetaxel

Prednisone

Tubulin Modulators

Antimitotic Agents

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

* Docetaxel: 60 mg/m²/day at C1 then 70 mg/m²/day for subsequent cycles every 3 weeks
* Prednisone 10 mg/day continuously

* Docetaxel weekly 35 mg/m²/day on day 1 and day 8 of each cycle (J1 = J21)
* Prednisone 10 mg/day continuously

* Docetaxel IV 60 mg/m²/d then IV 70 mg/m²/d for subsequent cycles every 3 weeks
* Prednisone 10 mg/day continuously

Docetaxel every 3 weeks + Prednisone

* Docetaxel weekly 35 mg/m²/day at day 1 and day 8 of each cycle (J1 = J21)
* Prednisone 10 mg/day continuously

Docetaxel weekly+ Prednisone

Loic Mourey

The objective of this study is to evaluate the feasibility of two different chemotherapy protocols with adjusted doses for patients aged 75 and over who often have medical problems other than prostate cancer. Patient will receive Docetaxel either every 3 weeks or weekly. In both cases, chemotherapy is combined with prednisone. The protocol will be considered feasible when patient will receive 6 cycles of chemotherapy (1 cycle = 3 weeks).

Additionally to this primary objective, efficacy will also be evaluated for both protocols as well as tolerance to treatment, quality of life and evolution of geriatric data.

Standard management of castration-resistant metastatic prostate cancer is represented by chemotherapy with Docetaxel 75 mg/m² every 3 weeks combined with Prednisone since a symptomatic and overall survival benefit was demonstrated.

Although this benefit is independent of age in the study by Tannock (cut-off:69), it does not seem possible to extrapolate these results, obtained in a selected population, to the majority of patients we encounter in daily practice, \>= 75 years old and / or unfit.

Retrospective studies have shown that chemotherapy was feasible, at standard or adapted doses in an unselected elderly population with good results in terms of tolerance and efficacy over symptoms.

Our study aims to evaluate prospectively the feasibility of a chemotherapy with Docetaxel/Prednisone administered every 3 weeks (60 mg / m² at D1C1 then 70 mg / m² at D1 for subsequent cycles if tolerance is good) or weekly (35mg / m² at D1 and D8 with Day 1 = Day 21) to patients \>= 75 years old, evaluated by comprehensive geriatric assessment, belonging to group 2 "vulnerable" or to group 3 "frail" of the classification proposed by the International Society of Geriatric Oncology (SIOG).

Feasibility is defined as the possibility for a patient to receive 6 cycles of chemotherapy without withdrawal. Reasons for study withdrawal were defined by the GERICO Group and are the followings:

* stop or delay of chemotherapy \> 2 weeks
* Necessity to reduce the dose of chemotherapy \> 25 %
* febrile neutropenia or non-haematological grade 3 toxicity (except alopecia) according to NCI-CTCAE V4.0.
* Geriatric criterion (Activity of Daily Living (ADL) decrease \>= 2 points)

The statistical methodology used is a double randomized phase II after stratification according to the SIOG criteria, based on a Simon Optimum plan.

A pharmacokinetic / pharmacodynamic study is associated to our project, based on a method of population pharmacokinetic. The aim is to highlight predictors of the haematological tolerance of this chemotherapy by evaluating clinical, geriatric and biological parameters.

The results of this study will support the terms of prescription of chemotherapy, in patients aged 75 and over, classified as "vulnerable" or "frail" regarding SIOG criteria, with defined geriatric assessment.

Feasibility of a Chemotherapy With Docetaxel-Prednisone for Castration-resistant Metastatic Prostate Cancer Elderly Patients

Randomized Phase II Study Evaluating the Feasibility of a Chemotherapy With Docetaxel-Prednisone in a Weekly Schedule or Every 3 Weeks, for Castration-resistant Metastatic Prostate Cancer Elderly Patients (>=75), "Vulnerable" or "Frail" , as Defined by the Criteria of the International Society of Geriatric Oncology (SIOG)

Main criteria is the rate of patients receiving 6 cycles of treatment without experiencing any of the following criteria:

* Stop or delay of chemotherapy \> 2 weeks
* Necessity to reduce the dose of chemotherapy \> 25 %
* Febrile neutropenia or non-haematological grade 3 toxicity (except alopecia)according to NCI-CTCAE V4.0
* Geriatric criterion ( ADL decrease \>= 2 points)

Overall Survival is defined as the time from randomization until death for any cause or last follow-up news (censored data).

The impact of the chemotherapy will be evaluated on Comprehensive Geriatric Assessment :

* Test de screening G8
* Cumulative Illness Rating Scale(CIRSG)
* Folstein Mini Mental State (MMS)
* Activity of Daily Living (ADL)
* Instrumental Activity of Daily Living (IADL)
* Geriatric Depression Scale (GDS)
* Mini Nutritionnal Assessment (MNA)

Tolerance and safety will be assessed through recording of adverse events using NCI-CTCAE toxicity classification V4.0.

The impact of the chemotherapy is evaluated on the European Organisation for Research and Treatment of Cancer (EORTC) Quality Of Life - Questionnaire - QLQ-C30

Tolerance and safety will be assessed through vital signs measurement.

Efficacy will be assessed through monitoring PSA values

Spots Global Cancer Trial Database for docetaxel every 3 weeks + prednisone