Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Flutamide, Suramin, and Hydrocortisone in Treating Patients with Prostate Cancer

Basic Trial Information

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.

Entry 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

George Wilding, MD, Protocol chair		Ph: 608-263-8610; 800-622-8922 Email: gxw@medicine.wisc.edu

Cancer and Leukemia Group B

Nancy Dawson, MD, Protocol chair (Contact information may not be current)		Ph: 202-782-6751

Southwest Oncology Group

A. Sartor, MD, Protocol chair (Contact information may not be current)		Ph: 504-568-5148

Registry Information
Official Title		PHASE III TRIAL OF ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE + SURAMIN + HYDROCORTISONE VS ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE IN PATIENTS WITH METASTATIC PROSTATE CANCER
Trial Start Date		1996-10-31
Trial Completion Date		1998-04-17
Registered in ClinicalTrials.gov		NCT00002881
Date Submitted to PDQ		1996-10-31
Information Last Verified		2007-05-10
NCI Grant/Contract Number		CA21115

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