Know Cancer

forgot password

Treatment of Metastatic Prostate Cancer That is Hormone-Independent: Evaluation of the Role of Chemotherapy on the Quality of Life of Patients. Phase II Study

Phase 3
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

Treatment of Metastatic Prostate Cancer That is Hormone-Independent: Evaluation of the Role of Chemotherapy on the Quality of Life of Patients. Phase II Study

OBJECTIVES: I. Determine the effect of weekly doxorubicin on the quality of life of patients
with metastatic, hormone-refractory, symptomatic prostate cancer. II. Determine the
contribution of this treatment on control of pain in these patients. III. Determine the
toxicity of this regimen in these patients. IV. Determine the objective response and
biological observations in these patients after this treatment. V. Determine the effect of
this regimen on survival of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms. Arm I: Patients receive methylprednisolone IV weekly for 3 months. Arm II:
Patients receive methylprednisolone IV and doxorubicin IV weekly for 3 months. Quality of
life is assessed before treatment, every 4 weeks during treatment, and then every 3 months.
Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study within 3 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven, symptomatic prostate cancer Appearance or
aggravation of clinical symptoms with progression of disease Bone pain OR Urethral
compression OR 20% decrease in performance status Metastatic disease Local-regional or
distant secondary tumors Documented radiologically or scintigraphically Hormone-refractory
as defined by progression while on hormone treatment (simple castration or complete
androgen blockage) Progressive disease No urethral or cervical stenosis Increase of
greater than 25% prostatic volume on endorectal echography No documentation by PSA
increase or imagery only Hormone castration verified by testosterone less than 0.5 ng/mL
No history of CNS metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life
expectancy: No specified Hematopoietic: Neutrophil count greater than 1500/mm3 Platelet
count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin less than
1.5 times normal Renal: Creatinine less than 1.6 mg/dL Cardiovascular: Ventricular
ejection fraction at least 50% Other: No contraindication to anthracycline treatment No
prior primary cancer except basal cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Arm I: No concurrent chemotherapy Endocrine therapy: At least 1 month since
prior hormone therapy, including estramustine, except LHRH agonists, which continue Arm I:
No concurrent estramustine Radiotherapy: At least 3 months since prior strontium 89 No
concurrent strontium Surgery: See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Stephane Culine, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Val d'Aurelle - Paul Lamarque


United States: Federal Government

Study ID:




Start Date:

October 1998

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms