Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer

• Status: Completed
• Trial end date: 2015-12-15
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, may stop the adrenal glands from making androgens. 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. Giving hormone therapy together with docetaxel may be an effective treatment for prostate cancer. It is not yet known whether giving hormone therapy together with docetaxel is more effective than hormone therapy alone in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying hormone therapy and docetaxel to see how well they work compared to hormone therapy alone in treating patients with metastatic prostate cancer.

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

Details

• Lead Sponsor: UNICANCER
• Treatments: Androgen Antagonists; Docetaxel; Goserelin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed prostate adenocarcinoma

• Metastatic disease

• Measurable or evaluable disease

• No brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• WBC ≥ 2,000/mm^3

• Absolute neutrophil count ≥ 1,000/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN) (2.5 times normal if hepatic metastases are present)

• AST and ALT ≤ 1.5 times ULN (2.5 times normal if hepatic metastases are present)

Renal

• Creatinine ≤ 150 μmol/L

Cardiovascular

• No symptomatic coronary disease

• No congenital cardiac insufficiency

• No New York Heart Association class III or IV cardiovascular disease

• No other severe cardiovascular disease

Other

• No severe peripheral neuropathy

• No active infection

• No other malignancy within the past 5 years except basal cell skin cancer

• No familial, social, geographical, or psychological situation that would preclude study compliance and follow-up

• No other serious disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for metastatic prostate cancer

• Prior chemotherapy allowed provided all of the following are true:

• Chemotherapy was completed > 1 year ago

• Prostate-specific antigen level has remained stable

• No development of metastases within 1 year after completion of chemotherapy

Endocrine therapy

• Prior hormonal therapy within the past 2 months allowed for metastatic prostate cancer

Radiotherapy

• More than 4 weeks since prior radiotherapy to metastatic sites

Surgery

• No prior surgical castration

Other

• No other concurrent investigational drugs