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

Alternate Title

Hydrocortisone Plus Aminoglutethimide or Ketoconazole in Treating Patients With Localized Stage IV Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Not specified	NCI	MCC-12219 MCC-IRB-5722, NCI-G00-1863, NCT00006371

Objectives

I. Determine the PSA response proportion and duration of response of patients 
with localized stage IV (D0.5) adenocarcinoma of the prostate treated with 
early medical adrenalectomy using hydrocortisone combined with 
aminoglutethimide or ketoconazole after prior antiandrogen withdrawal.

II. Compare the incidence of grades 3-4 toxicities of these regimens in these 
patients. 

III. Correlate adrenal androgen suppression with response in these patients.

Entry Criteria

Disease Characteristics:

Histologically proven adenocarcinoma of the prostate 
 Stage IV (D0.5; no evidence of disease on CT or bone scan after testicular
  androgen ablation) 
 PSA progression after testicular androgen ablation with or without
  antiandrogen therapy
   Progression is defined as at least 2 consecutive rising PSA levels (drawn
    at least 2 weeks apart) with a greater than 50% rise above the last nadir  
    level (arbitrary PSA at least 2 ng/dL)

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 Not specified

Endocrine therapy:
 See Disease Characteristics
 Greater than 4 weeks since prior flutamide (6 weeks for bicalutamide or
  nilutamide) 
 No prior aminoglutethimide or ketoconazole for prostate cancer
 Continuation of primary testicular androgen suppression (i.e., LHRH analog)
  required

Radiotherapy:
 Not specified

Surgery:
 Not specified

Other: 
 No concurrent terfenadine, astemizole, cisapride, or other medicines known to
  interact with ketoconazole

Patient Characteristics:

Age:
 Not specified

Performance status:
 ECOG 0-2

Life expectancy:
 Not specified

Hematopoietic:
 Not specified

Hepatic:
 Not specified

Renal:
 Not specified

Other:
 No other medical conditions that would increase risk
 Fertile patients must use effective contraception

Expected Enrollment

A total of 50 patients will be accrued for this study.

Outline

Patients are stratified according to prior antiandrogen therapy (yes vs no).  
Patients with prior antiandrogen therapy begin study therapy after appropriate 
antiandrogen withdrawal, while those without such prior therapy begin study 
therapy immediately. 

Patients undergo medical adrenalectomy using hydrocortisone combined with 
aminoglutethimide OR ketoconazole.  Oral hydrocortisone is administered twice 
daily.  Oral aminoglutethimide is administered twice daily for 1 week and then 
4 times daily during subsequent weeks.  Oral ketoconazole is administered 
three times daily.  Combination treatment continues in the absence of disease 
progression or unacceptable toxicity.

Trial Contact Information

Trial Lead Organizations

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Mayer Fishman, MD, PhD, Protocol chair		Ph: 813-745-8311; 888-663-3488 Email: mayer.fishman@moffitt.org

Registry Information
Official Title		A Phase II Trial of Early Medical Adrenalectomy for "D0.5" Prostate Cancer
Trial Start Date		2000-05-16
Trial Completion Date		2002-12-31
Registered in ClinicalTrials.gov		NCT00006371
Date Submitted to PDQ		2000-08-25
Information Last Verified		2009-07-06
NCI Grant/Contract Number		CA76292

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