Clinical trial · Interventional
Flutamide, Suramin, and Hydrocortisone in Treating Patients With Prostate Cancer
PHASE III TRIAL OF ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE + SURAMIN + HYDROCORTISONE VS ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE IN PATIENTS WITH METASTATIC PROSTATE CANCER
NCT00002881CI-TRIAL-00004091completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Hormone therapy may be an effective treatment for prostate cancer. PURPOSE: Randomized phase III trial to evaluate the effectiveness of treatment with flutamide and suramin with or without hydrocortisone in men who have metastatic or recurrent prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| flutamide | Drug | Flutamide | ALIAS |
| goserelin acetate | Drug | Goserelin | ALIAS |
| leuprolide acetate | Drug | Leuprolide | ALIAS |
| orchiectomy | Procedure | — | UNRESOLVED |
| suramin | Drug | — | UNRESOLVED |
| therapeutic hydrocortisone | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.