Prostate Cancer, Androgen Deprivation Withdrawal and Intermittent Chemotherapy
NCT ID: NCT01224405
Last Updated: 2010-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
600 participants
INTERVENTIONAL
2010-04-30
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment arm
ten docetaxel cycles + maintenance androgen deprivation.
Docetaxel + LH-RH analogues
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.
suspension arm
Ten Docetaxel cycles + stop androgen deprivation therapy
Docetaxel
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.
intermittent arm
Intermittent Docetaxel
Docetaxel
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.
Continuous arm
Continuous Docetaxel
Continuous Docetaxel
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.
Continuous Docetaxel
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.
Interventions
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Docetaxel + LH-RH analogues
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
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.
Docetaxel
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.
Continuous Docetaxel
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.
Continuous Docetaxel
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
\-
18 Years
MALE
No
Sponsors
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University of Turin, Italy
OTHER
Responsible Party
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Dipartimento Scienze Cliniche e Biologiche Università di Torino
Principal Investigators
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Alfredo Berruti, PHD
Role: STUDY_CHAIR
Medical Oncology - Hospital San Luigi Gonzaga Orbassano (TO) - Italy
Bruno Castagneto, MD
Role: STUDY_DIRECTOR
Medical Oncology - Hospital San Giacomo of Novi Ligure (AL) Italy
Marcello Tucci, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Oncology - Hospital San Luigi Gonzaga of Orbassano (TO) - Italy
Locations
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Davide Perroni
Saluzzo, Cuneo, Italy
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
Luigi Toniolo
Garbagnate Milanese, , Italy
Sergio Bretti
Ivrea, , Italy
Giovanni Ucci
Lodi, , Italy
Pierfranco Conte
Modena, , Italy
Carla Sculli
Mondovì, , Italy
Oscar Alabiso
Novara, , Italy
Bruno Castagneto
Novi Ligure, , Italy
Giovanna Succu
Nuoro, , Italy
Alfredo Berruti
Orbassano (Torino), , Italy
Luigi Dogliotti
Orbassano (Torino), , Italy
Luigi Cavanna
Piacenza, , Italy
Giorgio Cruciani
Ravenna, , Italy
Corrado Boni
Reggio Emilia, , Italy
Riccardo Ratti
Sanremo, , Italy
Francesco Ferrau
Taormina, , Italy
Fausto Roila
Terni, , Italy
Carlo Alberto Raucci
Torino, , Italy
Guido Vietti Ramus
Torino, , Italy
Libero Ciuffreda
Torino, , Italy
Gianpiero Fasola
Udine, , Italy
Sergio Cozzi
Verbania, , Italy
Domenico Amoroso
Viareggio, , Italy
Countries
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Other Identifiers
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EudraCT 2010-019004-24
Identifier Type: -
Identifier Source: org_study_id