The study includes the recruitment of patients with advanced prostate cancer resistant to chemical castration This is a multicenter prospective trial randomized phase III
The study includes the recruitment of patients with advanced prostate cancer resistant to chemical castration This is a multicenter prospective trial randomized phase III This study design that includes a double randomizzzazione aims generally demonstrating non-inferiority in terms of survival of the suspension dell'ormonoterapia versus the maintenance and / or administration of intermittent versus continuous administration of chemotherapy in patients with prostate cancer resistant to chemical castration I started to line chemotherapy with Docetaxel.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Docetaxel will be administered at a dose of 75 mg/m2 per square meter as a 1-hour intravenous infusion on day 1 every 21 days in association to 5 mg of prednisone orally twice daily. In patients randomised to arms A up to 10 cycles of docetaxel will be planned in association to maintenance of LH-RH analogues administration.
Docetaxel will be administered at a dose of 75 mg/m2 per square meter as a 1-hour intravenous infusion on day 1 every 21 days in association to 5 mg of prednisone orally twice daily. In patients randomised to arms B up to 10 cycles of docetaxel will be planned, in association to stopping LH-RH analogues.
Patients randomised in the arms AB1 (intermittent docetaxel) will suspend treatment after at least 4 cycles if their PSA level will be reduced \>50%. Docetaxel treatment will be resumed when the serum PSA will rise by \>50% from the lowest PSA level recorded and will be \>10 ng/mL or when there will be other evidence of disease progression. PSA progression must to be confirmed with a second assessment after 2 weeks before deciding to resume docetaxel administration.
Davide Perroni
Saluzzo, Cuneo, Italy
overall survival
The primary aim of the study will be the demonstration of non inferiority in terms of overall survival of stopping androgen deprivation therapy (arm B) versus maintenance androgen deprivation therapy (arms A) and intermittent docetaxel therapy (arm AB1) versus continuous docetaxel therapy (arms AB2) up to ten cycles.
Time frame: six years
Toxicity
Toxicity graded according to NCI Criteria
Time frame: six years
Progression free survival
Progression free survival measured according to Prostate Cancer Clinical Trials Working Group
Time frame: six years
Quality of life
Quality of life evaluated according to FACT-P questionnaire
Time frame: six years
Pain
Pain response evaluated by Mc-Gill Pain Questionnaire
Time frame: six years
Cost Analysis
A cost minimization analysis will be performed in order to find if there is a treatment strategy that may achieve the same outcome for least cost. The analysis will focus on the direct medical costs of each treatment, collected at patient level.
Time frame: six years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Patients randomised in the arms AB2 (continuous docetaxel) will continue treatment up to ten cycles after even if their PSA level at 4 cycles will be reduced \>50% or will reach a level \<4 ng/mL.
Patients randomised in the arms AB1(intermittent docetaxel) will continue treatment up to ten cycles even if their PSA level after 4 cycles will be reduced \>50% or will reach a level \<4 ng/mL.
Roberto Faggiuolo
Alba, Italy
Franco Testore
Asti, Italy
Mario Clerico
Biella, Italy
Andrea Martoni
Bologna, Italy
Massimo Aglietta
Candiolo (Torino), Italy
Alberto Muzio
Casale Monferrato, Italy
Mario Botta
Casale Monferrato, Italy
Rodolfo Passalacqua
Cremona, Italy
Marco Merlano
Cuneo, Italy
...and 22 more locations