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PHASE III TRIAL OF ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE + SURAMIN + HYDROCORTISONE VS ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE IN PATIENTS WITH METASTATIC PROSTATE CANCER


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

PHASE III TRIAL OF ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE + SURAMIN + HYDROCORTISONE VS ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE IN PATIENTS WITH METASTATIC PROSTATE CANCER


OBJECTIVES: I. Compare time to progression and survival in patients with metastatic or
recurrent adenocarcinoma of the prostate treated with orchiectomy or LHRH analogue (i.e.
leuprolide or goserelin) plus flutamide with vs. without suramin and hydrocortisone. II.
Compare these two treatments with respect to qualitative and quantitative toxic effects.
III. Evaluate normalization of prostatic-specific antigen (PSA), duration of PSA response,
and the use of PSA as a surrogate marker of tumor response in these patients. IV. Compare
these two treatments with respect to quality of life and pain status.

OUTLINE: This is a randomized study. Patients are stratified by their choice of androgen
suppression technique and by participating institution. Within 3 days after randomization,
all patients receive daily flutamide. On day 4, patients undergo orchiectomy or begin
monthly LHRH analogue therapy with leuprolide or goserelin. Patients randomized to receive
suramin begin a 12-week course 8-25 days after orchiectomy/LHRH therapy. Hydrocortisone
replacement therapy begins concomitantly with suramin and continues for at least 3 months
after the completion of suramin treatment or until disease progression intervenes. Patients
are followed every 3 months.

PROJECTED ACCRUAL: A total of 800-1,000 patients will be entered within 3.25 to 4.25 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate that is
stage D2 Measurable or evaluable disease required with at least one of the following: At
least 7 bone lesions Visceral involvement No more than 50% replacement of liver by tumor
No clinical suspicion of brain metastases No spinal cord compression

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 (ECOG 3 allowed if
increase due only to pain) Life expectancy: At least 3 months Hematopoietic: (within 2
weeks prior to entry) WBC at least 3,000 AGC at least 1,500 Platelets at least 100,000
Hemoglobin at least 9.0 g/dL Hepatic: (within 2 weeks prior to entry) Bilirubin no greater
than 2 times normal AST and ALT no greater than 2 times normal PT and PTT normal Albumin
at least 3.0 g/dL Renal: Creatinine no greater than 2 mg/dL Creatinine clearance at least
60 mL/min BUN no greater than twice normal Cardiovascular: No myocardial infarction within
6 months No NYHA class III/IV status No history of thromboembolic or hemorrhagic
cerebrovascular accident No disseminated intravascular coagulation No anticoagulant
therapy (aspirin allowed for other uses) Other: No active bacterial infection No HIV or
hepatitis B infection No other malignancy within the past 5 years except curatively
treated nonmelanoma skin cancer or carcinoma in situ cancer of any site

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biological response modifier therapy
Chemotherapy: No prior chemotherapy (including suramin) Endocrine therapy: At least 1 year
since any adjuvant or neoadjuvant hormone therapy No more than 4 months of therapy as part
of initial prostate cancer therapy Prior finasteride for benign prostatic hypertrophy
allowed No systemic steroids other than hydrocortisone (steroid inhalers allowed)
Radiotherapy: At least 4 weeks since radiotherapy (90 days since strontium) Surgery:
Recovered from prior surgery

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

George Wilding, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Federal Government

Study ID:

CDR0000065185

NCT ID:

NCT00002881

Start Date:

October 1996

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000