Advanced Prostate CancerPhase 3PON-PC-02NCT01224405
Prostate Cancer, Androgen Deprivation Withdrawal and Intermittent Chemotherapy
A Phase 3 study testing Docetaxel + LH-RH analogues, Docetaxel and Continuous Docetaxel in people with Advanced Prostate Cancer, run by University of Turin, Italy at 32 sites in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Advanced Prostate Cancer
- What is being tested?
- Docetaxel + LH-RH analogues, Docetaxel and Continuous Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 32 sitesItaly
- Study dates
- Apr 2010to Apr 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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,
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- 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
- 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.
- -
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Italy32 sites
Roberto Faggiuolo
Alba
Franco Testore
Asti
Mario Clerico
Biella
Andrea Martoni
Bologna
Massimo Aglietta
Candiolo (Torino)
Alberto Muzio
Casale Monferrato
Mario Botta
Casale Monferrato
Rodolfo Passalacqua
Cremona
Marco Merlano
Cuneo
Luigi Toniolo
Garbagnate Milanese
Sergio Bretti
Ivrea
Giovanni Ucci
Lodi
Pierfranco Conte
Modena
Carla Sculli
Mondovì
Oscar Alabiso
Novara
Bruno Castagneto
Novi Ligure
Giovanna Succu
Nuoro
Alfredo Berruti
Orbassano (Torino)
Luigi Dogliotti
Orbassano (Torino)
Luigi Cavanna
Piacenza
Giorgio Cruciani
Ravenna
Corrado Boni
Reggio Emilia
Davide Perroni
Saluzzo, Cuneo
Riccardo Ratti
Sanremo
Francesco Ferrau
Taormina
Fausto Roila
Terni
Carlo Alberto Raucci
Torino
Guido Vietti Ramus
Torino
Libero Ciuffreda
Torino
Gianpiero Fasola
Udine
Sergio Cozzi
Verbania
Domenico Amoroso
Viareggio
About this study
Official title: Androgen Deprivation Withdrawal Versus Maintenance and Intermittent Chemotherapy Versus Continuous in Prostate Cancer Patients With Castrate Resistant Disease
The study includes the recruitment of patients with advanced prostate cancer resistant to chemical castration This is a multicenter prospective trial randomized phase III
Read the 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.
- Conditions
- Advanced Prostate Cancer
- Being tested
- Docetaxel + LH-RH analogues, Docetaxel, Continuous Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel + LH-RH analoguesDrug
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.
DocetaxelDrug
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.
DocetaxelDrug
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 DocetaxelDrug
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 DocetaxelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Active comparator | ten docetaxel cycles + maintenance androgen deprivation. Receives: Drug: Docetaxel + LH-RH analogues |
| suspension arm | Experimental | Ten Docetaxel cycles + stop androgen deprivation therapy Receives: Drug: Docetaxel |
| intermittent arm | Experimental | Intermittent Docetaxel Receives: Drug: Docetaxel |
| Continuous arm | Active comparator | Continuous Docetaxel Receives: Drug: Continuous Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six years
Secondary outcomes (5)
Toxicity
Toxicity graded according to NCI Criteria
Measured: six years
Progression free survival
Progression free survival measured according to Prostate Cancer Clinical Trials Working Group
Measured: six years
Quality of life
Quality of life evaluated according to FACT-P questionnaire
Measured: six years
Pain
Pain response evaluated by Mc-Gill Pain Questionnaire
Measured: 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.
Measured: six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2010
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Investigators
- Alfredo Berruti, PHD, Study chair, Medical Oncology - Hospital San Luigi Gonzaga Orbassano (TO) - ItalyBruno Castagneto, MD, Study director, Medical Oncology - Hospital San Giacomo of Novi Ligure (AL) ItalyMarcello Tucci, MD, Principal investigator, Medical Oncology - Hospital San Luigi Gonzaga of Orbassano (TO) - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224405
- Sponsor's protocol ID
- EudraCT 2010-019004-24
- Acronym
- PON-PC-02
- Status last verified
- Jun 2010
- First submitted
- 3 Sep 2010
- Last updated
- 20 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Androgen Deprivation Withdrawal Versus Maintenance and Intermittent Chemotherapy Versus Continuous in Prostate Cancer Patients With Castrate Resistant Disease
- ClinicalTrials.gov ID
- NCT01224405
- Acronym / sponsor ID
- PON-PC-02 / EudraCT 2010-019004-24
- Conditions
- Advanced Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Apr 2016 (estimated)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Active comparator | Drug: Docetaxel + LH-RH analoguesten docetaxel cycles + maintenance androgen deprivation. |
| suspension arm | Experimental | Drug: DocetaxelTen Docetaxel cycles + stop androgen deprivation therapy |
| intermittent arm | Experimental | Drug: DocetaxelIntermittent Docetaxel |
| Continuous arm | Active comparator | Drug: Continuous DocetaxelContinuous Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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,
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel + LH-RH analoguesDocetaxel 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. | Drug | Treatment arm |
| DocetaxelDocetaxel 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. | Drug | suspension arm |
| DocetaxelPatients 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. | Drug | intermittent arm |
| Continuous DocetaxelPatients 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 arm |
| Continuous DocetaxelPatients 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. | Drug | Continuous arm |
Primary outcome
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.
5 secondary outcomes
Toxicity
Time frame: six years
Progression free survival
Time frame: six years
Quality of life
Time frame: six years
Pain
Time frame: six years
Cost Analysis
Time frame: six years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfredo Berruti, PHD study chair
Medical Oncology - Hospital San Luigi Gonzaga Orbassano (TO) - Italy
Bruno Castagneto, MD study director
Medical Oncology - Hospital San Giacomo of Novi Ligure (AL) Italy
Marcello Tucci, MD principal investigator
Medical Oncology - Hospital San Luigi Gonzaga of Orbassano (TO) - Italy
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel + LH-RH analogues, Docetaxel and Continuous Docetaxel in people with Advanced Prostate Cancer, run by University of Turin, Italy at 32 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: six years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2010.