PainPhase 3NCT00796458
Androgen Ablation With or Without Docetaxel in Treating Patients With Advanced Prostate Cancer
A Phase 3 study testing docetaxel and releasing hormone agonist therapy in people with Pain and Prostate Cancer, run by A.O.U. San Giovanni Battista di Torino, Italy at 1 site in Italy.
Trial summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pain, Prostate Cancer
- What is being tested?
- docetaxel and releasing hormone agonist therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2005to Oct 2013
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Meets one of the following criteria
- Metastatic disease
- Systemic progressive disease after locoregional therapy (surgery or radiotherapy)
- No metastatic disease AND meets one of the following criteria:
- Circulating PSA levels ≥ 50 ng/mL (confirmed by ≥ 2 subsequent evaluations)
- Biochemical progression with a PSA doubling time < 6 months (with ≥ 3 measurements taken 1 month apart) after primary locoregional treatment (radical prostatectomy or radiotherapy) with curative intent
- Prostate-confined tumor with high-risk features whose therapy of choice is androgen deprivation
- No symptomatic brain metastases or leptomeningeal disease
PATIENT CHARACTERISTICS:
- ECOG or Zubrod performance status 0-2
- Life expectancy ≥ 6 months
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Bilirubin ≤ 2.0 mg/dL
- AST/ALT ≤ 1.5 times upper limit of normal
- Creatinine ≤ 1.5 mg/dL
- No active infection requiring IV antibiotics
- No active ulcer, unstable diabetes mellitus, or other contraindication to corticotherapy
- None of the following cardiovascular conditions:
- Uncompensated heart failure (ejection fraction < 40%)
- Myocardial infarction or revascularization procedure within the past 6 months
- Unstable angina pectoris
- Uncontrolled cardiac arrhythmia
- No other severe clinical condition that, in the judgment of the local investigator, would place the patient at undue risk or interfere with the study
- Not a prisoner
- No prior malignancy, except for non-melanoma skin cancer, in situ cervical carcinoma, or other cancer that was curatively treated with no evidence of disease for ≥ 5 years
- No familial, social, or geographical condition or significant neurologic or psychiatric disorder that would preclude understanding or rendering informed consent or fully complying with study treatment and follow-up
PRIOR CONCURRENT THERAPY:
- At least 5 years since prior radiotherapy outside the prostate
- Prior hormonal therapy allowed provided it was administered for ≤ 6 months
- At least 12 months since prior hormonal therapy
- More than 30 days since prior participation in another clinical trial involving investigational agents
- No prior surgical castration
- Concurrent androgen deprivation for prostate cancer allowed provided it was started ≤ 3 months prior to initiation of study treatment
- Concurrent anticoagulant treatment allowed
- No other concurrent investigational drugs
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Rete Oncologica Piemontese - Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Turin, 10126
Isabella Chiappino, MD, 39-011-633-4250
About this study
Official title: Phase III Study of Chemo-hormonal Therapy Versus Hormonal Therapy Alone in Advanced Hormone-naives Prostate Cancer Patients.
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving androgen ablation therapy together with docetaxel is more effective than giving androgen ablation therapy alone in treating patients with advanced prostate cancer.
PURPOSE: This randomized phase III trial is studying androgen ablation and docetaxel to see how well they work compared with androgen ablation alone in treating patients with advanced prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the 2-year progression-free survival rate (biological progression and/or clinical progression) in patients with advanced prostate cancer treated with androgen ablation with vs without docetaxel.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Compare the time to treatment failure in patients treated with these regimens.
- Compare the toxicity profiles of these regimens in these patients.
- Compare the PSA response rate in patients treated with these regimens.
- Compare the response rate in patients with measurable disease treated with these regimens.
- Compare the percentage of patients who undergo PSA normalization.
- Compare the quality of life of patients treated with these regimens.
- Compare the efficacy of these regimens in controlling bone pain in these patients.
- Compare the changes in chromogranin A levels in patients treated with these regimens.
- Compare the total cost of care of patients treated with these regimens.
OUTLINE: This is a multicenter study.
Patients receive luteinizing hormone-releasing hormone analogue (LHRH-A) therapy for 6 months. Patients also receive antiandrogen therapy during the first 5 weeks of LHRH-A therapy. After 6 months of LHRH-A therapy, patients with PSA response are randomized to 1 of 2 treatment arms.
- Arm I: Patients continue to receive LHRH-A therapy until disease progression.
- Arm II:Patients receive LHRH-A therapy as in arm I. Patients also receive docetaxel IV on day 1. Treatment with docetaxel repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients complete questionnaires during treatment to assess bone pain. Quality of life is also assessed.
After completion to study therapy, patients are followed for ≥ 2 years.
- Conditions
- Pain, Prostate Cancer
- Being tested
- docetaxel, releasing hormone agonist therapy
- Keywords
- pain, adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer, stage III prostate cancer
- Medical subject headings
- Pain, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
Given IV
releasing hormone agonist therapyDrug
Patients receive luteinizing hormone-releasing hormone analogue therapy until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Active comparator | Patients continue to receive LHRH-A therapy until disease progression. Receives: Drug: releasing hormone agonist therapy |
| Arm II | Experimental | Patients receive LHRH-A therapy as in arm I. Patients also receive docetaxel IV on day 1. Treatment with docetaxel repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: docetaxel; Drug: releasing hormone agonist therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression-free survival rate
Secondary outcomes (10)
Overall survival
Time to treatment failure
Toxicity as assessed by NCI CTCAE criteria
PSA response rate (> 50% reduction from baseline)
Disease response rate as assessed by RECIST criteria (in patients with measurable disease)
PSA normalization (normal range 0-4 ng/mL)
Quality of life
Efficacy of treatment in controlling bone pain
Changes in chromogranin A levels
Cost analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startApr 2005
- Primary completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O.U. San Giovanni Battista di Torino, Italy
- Sponsor type
- University, hospital or other
- Investigators
- Oscar Bertetto, MD, Principal investigator, Azienda Sanitaria Ospedale San Giovanni Battista Molinette di TorinoIsabella Chiappino, MD, A.O.U. San Giovanni Battista di Torino, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796458
- Sponsor's protocol ID
- GOUP-01/04
- Other IDs
- CDR0000626194, EUDRACT 2004-003495-11, EU-20892
- Status last verified
- Nov 2008
- First submitted
- 21 Nov 2008
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Chemo-hormonal Therapy Versus Hormonal Therapy Alone in Advanced Hormone-naives Prostate Cancer Patients.
- ClinicalTrials.gov ID
- NCT00796458
- Acronym / sponsor ID
- GOUP-01/04
- Conditions
- Pain, Prostate Cancer
- Keywords
- pain, adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer, stage III prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- A.O.U. San Giovanni Battista di Torino, ItalyUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Oct 2013 (estimated)
- First posted
- 24 Nov 2008 (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.
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving androgen ablation therapy together with docetaxel is more effective than giving androgen ablation therapy alone in treating patients with advanced prostate cancer.
PURPOSE: This randomized phase III trial is studying androgen ablation and docetaxel to see how well they work compared with androgen ablation alone in treating patients with advanced prostate cancer.
Detailed description
OBJECTIVES:
Primary
- Compare the 2-year progression-free survival rate (biological progression and/or clinical progression) in patients with advanced prostate cancer treated with androgen ablation with vs without docetaxel.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Compare the time to treatment failure in patients treated with these regimens.
- Compare the toxicity profiles of these regimens in these patients.
- Compare the PSA response rate in patients treated with these regimens.
- Compare the response rate in patients with measurable disease treated with these regimens.
- Compare the percentage of patients who undergo PSA normalization.
- Compare the quality of life of patients treated with these regimens.
- Compare the efficacy of these regimens in controlling bone pain in these patients.
- Compare the changes in chromogranin A levels in patients treated with these regimens.
- Compare the total cost of care of patients treated with these regimens.
OUTLINE: This is a multicenter study.
Patients receive luteinizing hormone-releasing hormone analogue (LHRH-A) therapy for 6 months. Patients also receive antiandrogen therapy during the first 5 weeks of LHRH-A therapy. After 6 months of LHRH-A therapy, patients with PSA response are randomized to 1 of 2 treatment arms.
- Arm I: Patients continue to receive LHRH-A therapy until disease progression.
- Arm II:Patients receive LHRH-A therapy as in arm I. Patients also receive docetaxel IV on day 1. Treatment with docetaxel repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients complete questionnaires during treatment to assess bone pain. Quality of life is also assessed.
After completion to study therapy, patients are followed for ≥ 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Active comparator | Drug: releasing hormone agonist therapyPatients continue to receive LHRH-A therapy until disease progression. |
| Arm II | Experimental | Drug: docetaxel, Drug: releasing hormone agonist therapyPatients receive LHRH-A therapy as in arm I. Patients also receive docetaxel IV on day 1. Treatment with docetaxel repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| docetaxelGiven IV | Drug | Arm II |
| releasing hormone agonist therapyPatients receive luteinizing hormone-releasing hormone analogue therapy until disease progression. | Drug | Arm I, Arm II |
Primary outcome
2-year progression-free survival rate
10 secondary outcomes
Overall survival
Time to treatment failure
Toxicity as assessed by NCI CTCAE criteria
PSA response rate (> 50% reduction from baseline)
Disease response rate as assessed by RECIST criteria (in patients with measurable disease)
PSA normalization (normal range 0-4 ng/mL)
Quality of life
Efficacy of treatment in controlling bone pain
Changes in chromogranin A levels
Cost analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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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.
Rete Oncologica Piemontese - Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Turin, Italy
Oscar Bertetto, MD principal investigator
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Isabella Chiappino, MD
A.O.U. San Giovanni Battista di Torino, Italy
1 site 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 and releasing hormone agonist therapy in people with Pain and Prostate Cancer, run by A.O.U. San Giovanni Battista di Torino, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year progression-free survival rate. 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 12 Aug 2013.