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Is docetaxel-prednisone (DP) feasible in frail elderly (age 75 or older) patients with castration-resistant metastatic prostate cancer (CRMPC)? GERICO10-GETUG P03 trial: A trial from elderly and genitourinary oncology UNICANCER groups.

93 Background: Standard treatment of CRMPC is DP 75 mg/m² every 3 weeks since a symptomatic and overall survival benefit was demonstrated. Little is known about feasibility of DP in unselected elderly patients (day to day practice).


METHODS
Randomized phase II study evaluating prospectively the feasibility of DP administered every 3 weeks (60 mg / m² C1 then 70 mg / m² for subsequent cycles) or weekly (35mg/m² D1D8 with Day 1 = Day 21) in 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 fulfilling the criteria for withdrawal from study defined "a priori" by GERICO group: - stop or delay chemotherapy > 2 weeks - necessity to reduce chemotherapy dose > 25% - febrile neutropenia or NCI CTC grade III non-haematological toxicity (except alopecia) - loss of autonomy ( Activity of Daily Living (ADL) decrease≥2 points) →geriatric criterion It is a double randomized phase II based on a Simon's optimum two stage design for each strata defined according to the SIOG criteria (α = 5%, 1-β = 90 %, p0 = 0.70 and p1 = 0.90). A pharmacokinetic / pharmacodynamic study (method of population pharmacokinetics) and pharmacogenetic study of PXR (pregnane X receptor) CYP3A4 and CYP3A5) are planed.


RESULTS
25 centers participate to the study (23 opened). 10 centers have included 22 patients (16 "vulnerable" and 6 "frail") from December 2010 until now.


CONCLUSIONS
The results of this study will support the prescription of chemotherapy and its modalities, in patients aged 75 and over, classified as "vulnerable" or "frail" according to SIOG criteria, after comprehensive geriatric assessment.