Docetaxel and Prednisone in Treating Patients With Hormone-Refractory Metastatic Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which schedule of docetaxel and prednisone is more effective in treating prostate cancer. PURPOSE: This randomized phase III trial is studying two different schedules of docetaxel and prednisone to compare how well they work in treating patients with metastatic prostate cancer.

Detailed Description
-----------------
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.

Official Title
-----------------
A Phase III Trial Comparing Docetaxel Every Third Week to Biweekly Docetaxel Monotherapy in Metastatic Hormone Refractory Prostate Cancer Patients - PROSTY Trial

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: docetaxel
* Drug: prednisone


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Drug: docetaxel<br>* Given in 3- or 4- week courses<br>Drug: prednisone<br>* Given in 3- or 4- week courses<br>|
| Experimental: Arm II<br>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. | Drug: docetaxel<br>* Given in 3- or 4- week courses<br>Drug: prednisone<br>* Given in 3- or 4- week courses<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment failure (TTF) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life every 6 weeks until TTF |  |  | 
| Safety |  |  | 
| Overall survival |  |  | 
| Response rate |  |  | 
| Use of epoetin beta |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer