A Phase III Trial Comparing Docetaxel Every Third Week to Biweekly Docetaxel Monotherapy in Metastatic Hormone Refractory Prostate Cancer Patients - PROSTY Trial
18 Years
N/A
Male
Prostate Cancer
Trial Information
A Phase III Trial Comparing Docetaxel Every Third Week to Biweekly Docetaxel Monotherapy in Metastatic Hormone Refractory Prostate Cancer Patients - PROSTY Trial
OBJECTIVES:
Primary
- Compare the time to treatment failure in patients with hormone-refractory metastatic
prostate cancer treated with two different schedules of docetaxel in combination with
prednisone.
Secondary
- Compare overall survival of patients treated with these regimens.
- Compare the response rate in patients treated with these regimens.
- Compare the safety of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the need for epoetin beta in patients treated with these regimens.
- Determine the effect of epoetin beta on hemoglobin response rate, transfusion rate, and
quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified
according to participating center and WHO performance status (0-1 vs 2). Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on days 1 and 15 and oral prednisone
once daily on days 1-28. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
- Arm II: Patients receive docetaxel IV over 1 hour on day 1 and prednisone once daily on
days 1-21. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
Patients who experience anemia (hemoglobin < 11 g/dL) receive epoetin beta subcutaneously
once weekly during chemotherapy.
Quality of life is assessed at baseline, every 6 weeks during study treatment, at completion
of study treatment, and then every 2 months thereafter.
After completion of study treatment, patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 360 patients (180 per treatment arm) will be accrued for this
study within 4 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Metastatic disease by imaging or clinical examination
- Hormone-refractory disease, defined as prostate-specific antigen (PSA) level > 10
µg/L AND rising between 2 sequential measurements
- Testosterone within castration levels by orchiectomy or medical castration comprising
luteinizing hormone-releasing hormone (LHRH) analogues
PATIENT CHARACTERISTICS:
Age
- Over 18
Performance status
- WHO 0-2
Life expectancy
- Not specified
Hematopoietic
- Neutrophil count ≥ 1,500/mm^3
- Hemoglobin ≥ 11.0 g/dL
- Platelet count ≥ 100,000/mm^3
Hepatic
- ALT and AST ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin normal
- Alkaline phosphatase ≤ 6 times ULN (unless due to the presence of extensive bone
disease)
- No serious liver disease
Renal
- Creatinine ≤ 1.5 times ULN
Cardiovascular
- No ischemic or thromboembolic cardiac disease
- No myocardial infarction within the past 12 months
- No other serious cardiac disease
Pulmonary
- No pulmonary emboli
Immunologic
- No active infection
- No autoimmune disease, including any of the following:
- Lupus
- Scleroderma
- Rheumatoid polyarthritis
Other
- No active peptic ulcer
- No unstable diabetes mellitus
- No contraindication to corticosteroids
- No other malignant disease within the past 5 years except basalioma
- No functional iron deficiency (i.e., transferrin saturation < 20%) that cannot be
treated with iron supplementation
- No other serious illness or medical condition
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 2 months since prior recombinant human epoetin alfa or any other
erythropoiesis-stimulating drug
Chemotherapy
- At least 3 weeks since prior estramustine
Endocrine therapy
- See Disease Characteristics
- At least 3 weeks since prior antiandrogen treatment
- Concurrent chemical castration with LHRH allowed provided patient has begun treatment
prior to study entry
- No initiation of chemical castration therapy during study treatment
Radiotherapy
- No prior radiotherapy to > 25% of bone marrow
- No prior radioisotope therapy
- Concurrent local palliative radiotherapy for pain allowed
Surgery
- See Disease Characteristics
- At least 4 weeks since prior surgery
Other
- No other prior cytostatic treatment
- Concurrent bisphosphonates allowed provided patient has begun treatment prior to
study entry
- No initiation of bisphosphonates during study treatment
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Time to treatment failure (TTF)
Safety Issue:
No
Principal Investigator
Pirkko Kellokumpu-Lehtinen
Investigator Role:
Principal Investigator
Investigator Affiliation:
Tampere University Hospital
Authority:
United States: Federal Government
Study ID:
AVENTIS-FIN-1-2003
NCT ID:
NCT00255606
Start Date:
August 2005
Completion Date:
August 2010
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage IV prostate cancer
- recurrent prostate cancer
- Prostatic Neoplasms
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