Clinical trial NCT01224405: Prostate Cancer, Androgen Deprivation Withdrawal and Intermittent Chemotherapy
Official title: Androgen Deprivation Withdrawal Versus Maintenance and Intermittent Chemotherapy Versus Continuous in Prostate Cancer Patients With Castrate Resistant Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Advanced Prostate Cancer
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 600
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study includes the recruitment of patients with advanced prostate cancer resistant to chemical castration This is a multicenter prospective trial randomized phase III

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. age over 18 years,
2. histologically documented adenocarcinoma of the prostate,
3. written informed consent to the study,
4. Castrate resistant metastatic prostate cancer in the presence of castrate levels of testosterone (\<50 ng/ml) and eligible to docetaxel chemotherapy. The condition of castrate resistant prostate cancer is the defined either as the documentation of a new metastasis or PSA increase more than 50% or increase more than 25% from a lower PSA value during previous hormone therapy in case of disease response or stabilization to previous hormone therapy, respectively. Absolute PSA increase should be greater than 5 ng/ml,
5. an elevated PSA level must have been documented within 4 weeks of initiating docetaxel chemotherapy,
6. more than 4 weeks since major surgery and fully recovered,
7. more than 4 weeks since any prior radiation with any toxicity attributable to radiation resolved to grade 1 or less,
8. more than 8 weeks since the last dose of strontium or samarium,
9. ECOG Performance Status more than/equal to 2,
10. life expectancy \>6 months,
11. required initial laboratory values: absolute neutrophil count \> 1500/ul Platelets \> 100,000/ul., Hemoglobin \> 8.0 g/dl, Creatinine, SGOT, SGPT less than 2.0 X upper limit of normal, Bilirubin less than/equal to upper limit of normal (ULN).
12. Appropriate patient compliance

Exclusion Criteria:

1. Patients with increased serum PSA levels with negative bone scan and CT scan.
2. Prior systemic chemotherapy for prostate cancer. Prior neoadjuvant or adjuvant chemotherapy is permitted if there was no evidence of disease relapse within 12 months of the last dose of chemotherapy,
3. Peripheral neuropathy \>grade 1,
4. myocardial infarction or significant change in anginal pattern within the last 6 months, symptomatic congestive heart failure (NYHA Class III or higher) or uncontrolled cardiac arrhythmia,
5. patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80,
6. poorly controlled diabetes (fasting blood glucose \>250) despite optimization of medical therapy, peptic ulcers or other contraindications to steroid therapy,
7. previous history of malignant disease with the exception of non melanoma skin cancer curatively treated,
8. significant neurologic or psychiatric diseases preventing patients to give a valid informed consent,
9. brain metastases,
10. prisoner status
11. because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded.

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Primary outcomes:
measure: overall survival
timeFrame: six years
Secondary outcomes:
measure: Toxicity
timeFrame: six years
measure: Progression free survival
timeFrame: six years
measure: Quality of life
timeFrame: six years
measure: Pain
timeFrame: six years
measure: Cost Analysis
timeFrame: six years
Other outcomes:
Locations:
city: Saluzzo
country: Italy
facility: Davide Perroni
state: Cuneo
city: Alba
country: Italy
facility: Roberto Faggiuolo
city: Asti
country: Italy
facility: Franco Testore
city: Biella
country: Italy
facility: Mario Clerico
city: Bologna
country: Italy
facility: Andrea Martoni
city: Candiolo (Torino)
country: Italy
facility: Massimo Aglietta
city: Casale Monferrato
country: Italy
facility: Alberto Muzio
city: Casale Monferrato
country: Italy
facility: Mario Botta
city: Cremona
country: Italy
facility: Rodolfo Passalacqua
city: Cuneo
country: Italy
facility: Marco Merlano
city: Garbagnate Milanese
country: Italy
facility: Luigi Toniolo
city: Ivrea
country: Italy
facility: Sergio Bretti
city: Lodi
country: Italy
facility: Giovanni Ucci
city: Modena
country: Italy
facility: Pierfranco Conte
city: Mondovì
country: Italy
facility: Carla Sculli
city: Novara
country: Italy
facility: Oscar Alabiso
city: Novi Ligure
country: Italy
facility: Bruno Castagneto
city: Nuoro
country: Italy
facility: Giovanna Succu
city: Orbassano (Torino)
country: Italy
facility: Alfredo Berruti
city: Orbassano (Torino)
country: Italy
facility: Luigi Dogliotti
city: Piacenza
country: Italy
facility: Luigi Cavanna
city: Ravenna
country: Italy
facility: Giorgio Cruciani
city: Reggio Emilia
country: Italy
facility: Corrado Boni
city: Sanremo
country: Italy
facility: Riccardo Ratti
city: Taormina
country: Italy
facility: Francesco Ferrau
city: Terni
country: Italy
facility: Fausto Roila
city: Torino
country: Italy
facility: Carlo Alberto Raucci
city: Torino
country: Italy
facility: Guido Vietti Ramus
city: Torino
country: Italy
facility: Libero Ciuffreda
city: Udine
country: Italy
facility: Gianpiero Fasola
city: Verbania
country: Italy
facility: Sergio Cozzi
city: Viareggio
country: Italy
facility: Domenico Amoroso
Study officials:
affiliation: Medical Oncology - Hospital San Luigi Gonzaga Orbassano (TO) - Italy
name: Alfredo Berruti, PHD
role: STUDY_CHAIR
affiliation: Medical Oncology - Hospital San Giacomo of Novi Ligure (AL) Italy
name: Bruno Castagneto, MD
role: STUDY_DIRECTOR
affiliation: Medical Oncology - Hospital San Luigi Gonzaga of Orbassano (TO) - Italy
name: Marcello Tucci, MD
role: PRINCIPAL_INVESTIGATOR
References: