Prostate Cancer, Androgen Deprivation Withdrawal and Intermittent Chemotherapy (PON-PC-02)
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| ClinicalTrials.gov Identifier: NCT01224405 |
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Recruitment Status : Unknown
Verified June 2010 by University of Turin, Italy.
Recruitment status was: Active, not recruiting
First Posted : October 20, 2010
Last Update Posted : October 20, 2010
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Sponsor:
University of Turin, Italy
Information provided by:
University of Turin, Italy
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Prostate Cancer | Drug: Docetaxel + LH-RH analogues Drug: Docetaxel Drug: Continuous Docetaxel | Phase 3 |
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 (Clinical Trial) |
| Estimated Enrollment : | 600 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Androgen Deprivation Withdrawal Versus Maintenance and Intermittent Chemotherapy Versus Continuous in Prostate Cancer Patients With Castrate Resistant Disease |
| Study Start Date : | April 2010 |
| Actual Primary Completion Date : | August 2010 |
| Estimated Study Completion Date : | April 2016 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Prostate cancer
MedlinePlus related topics:
Prostate Cancer
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Treatment arm
ten docetaxel cycles + maintenance androgen deprivation.
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Drug: 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. |
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Experimental: suspension arm
Ten Docetaxel cycles + stop androgen deprivation therapy
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Drug: 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. |
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Experimental: intermittent arm
Intermittent Docetaxel
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Drug: 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. |
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Active Comparator: Continuous arm
Continuous Docetaxel
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Drug: 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. Drug: 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. |
Primary Outcome Measures :
- overall survival [ Time Frame: six years ]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.
Secondary Outcome Measures :
- Toxicity [ Time Frame: six years ]Toxicity graded according to NCI Criteria
- Progression free survival [ Time Frame: six years ]Progression free survival measured according to Prostate Cancer Clinical Trials Working Group
- Quality of life [ Time Frame: six years ]Quality of life evaluated according to FACT-P questionnaire
- Pain [ Time Frame: six years ]Pain response evaluated by Mc-Gill Pain Questionnaire
- Cost Analysis [ Time Frame: six years ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- age over 18 years,
- histologically documented adenocarcinoma of the prostate,
- written informed consent to the study,
- 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,
- an elevated PSA level must have been documented within 4 weeks of initiating docetaxel chemotherapy,
- more than 4 weeks since major surgery and fully recovered,
- more than 4 weeks since any prior radiation with any toxicity attributable to radiation resolved to grade 1 or less,
- more than 8 weeks since the last dose of strontium or samarium,
- ECOG Performance Status more than/equal to 2,
- life expectancy >6 months,
- 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).
- Appropriate patient compliance
Exclusion Criteria:
- Patients with increased serum PSA levels with negative bone scan and CT scan.
- 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,
- Peripheral neuropathy >grade 1,
- 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,
- patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80,
- poorly controlled diabetes (fasting blood glucose >250) despite optimization of medical therapy, peptic ulcers or other contraindications to steroid therapy,
- previous history of malignant disease with the exception of non melanoma skin cancer curatively treated,
- significant neurologic or psychiatric diseases preventing patients to give a valid informed consent,
- brain metastases,
- prisoner status
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224405
Locations
| Italy | |
| 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 | |
Sponsors and Collaborators
University of Turin, Italy
Investigators
| Study Chair: | Alfredo Berruti, PHD | Medical Oncology - Hospital San Luigi Gonzaga Orbassano (TO) - Italy | |
| Study Director: | Bruno Castagneto, MD | Medical Oncology - Hospital San Giacomo of Novi Ligure (AL) Italy | |
| Principal Investigator: | Marcello Tucci, MD | Medical Oncology - Hospital San Luigi Gonzaga of Orbassano (TO) - Italy |
| Responsible Party: | Alfredo Berruti, Dipartimento Scienze Cliniche e Biologiche Università di Torino |
| ClinicalTrials.gov Identifier: | NCT01224405 History of Changes |
| Other Study ID Numbers: |
EudraCT 2010-019004-24 |
| First Posted: | October 20, 2010 Key Record Dates |
| Last Update Posted: | October 20, 2010 |
| Last Verified: | June 2010 |
Additional relevant MeSH terms:
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Docetaxel Androgens |
Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |