Back to resultsAndrogen Ablation With or Without Docetaxel in Treating Patients With Advanced Prostate Cancer
Primary Purpose
Pain, Prostate Cancer
Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
docetaxel
releasing hormone agonist therapy
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring pain, adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer, stage III prostate cancer
Eligibility Criteria
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
Sites / Locations
- Rete Oncologica Piemontese - Azienda Sanitaria Ospedale San Giovanni Battista Molinette di TorinoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm I
Arm II
Arm Description
Patients continue to receive LHRH-A therapy until disease progression.
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.
Outcomes
Primary Outcome Measures
2-year progression-free survival rate
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00796458
First Posted
November 21, 2008
Last Updated
August 9, 2013
Sponsor
A.O.U. San Giovanni Battista di Torino, Italy
1. Study Identification
Unique Protocol Identification Number
NCT00796458
Brief Title
Androgen Ablation With or Without Docetaxel in Treating Patients With Advanced Prostate Cancer
Official Title
Phase III Study of Chemo-hormonal Therapy Versus Hormonal Therapy Alone in Advanced Hormone-naives Prostate Cancer Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2005 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
A.O.U. San Giovanni Battista di Torino, Italy
4. Oversight
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Prostate Cancer
Keywords
pain, adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer, stage III prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Active Comparator
Arm Description
Patients continue to receive LHRH-A therapy until disease progression.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
releasing hormone agonist therapy
Intervention Description
Patients receive luteinizing hormone-releasing hormone analogue therapy until disease progression.
Primary Outcome Measure Information:
Title
2-year progression-free survival rate
Secondary Outcome Measure Information:
Title
Overall survival
Title
Time to treatment failure
Title
Toxicity as assessed by NCI CTCAE criteria
Title
PSA response rate (> 50% reduction from baseline)
Title
Disease response rate as assessed by RECIST criteria (in patients with measurable disease)
Title
PSA normalization (normal range 0-4 ng/mL)
Title
Quality of life
Title
Efficacy of treatment in controlling bone pain
Title
Changes in chromogranin A levels
Title
Cost analysis
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar Bertetto, MD
Organizational Affiliation
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Isabella Chiappino, MD
Organizational Affiliation
A.O.U. San Giovanni Battista di Torino, Italy
Facility Information:
Facility Name
Rete Oncologica Piemontese - Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabella Chiappino, MD
Phone
39-011-633-4250
12. IPD Sharing Statement
Learn more about this trial
Androgen Ablation With or Without Docetaxel in Treating Patients With Advanced Prostate Cancer
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