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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tampere University; University of Tampere
• Treatments: Docetaxel; Hormones; Prednisone

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