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A PHASE III TWO-ARM RANDOMIZED STUDY COMPARING ANTIANDROGEN WITHDRAWAL ALONE VERSUS ANTIANDROGEN WITHDRAWAL COMBINED WITH KETOCONAZOLE AND HYDROCORTISON IN PATIENTS WITH ADVANCED PROSTAGE CANCER


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

Thank you

Trial Information

A PHASE III TWO-ARM RANDOMIZED STUDY COMPARING ANTIANDROGEN WITHDRAWAL ALONE VERSUS ANTIANDROGEN WITHDRAWAL COMBINED WITH KETOCONAZOLE AND HYDROCORTISON IN PATIENTS WITH ADVANCED PROSTAGE CANCER


OBJECTIVES: I. Compare the response rate and duration of response to antiandrogen withdrawal
alone vs. antiandrogen withdrawal plus ketoconazole/hydrocortisone in patients with advanced
hormone-refractory prostate cancer. II. Compare the response rate and duration of response
to ketoconazole/hydrocortisone in patients treated with previous vs. simultaneous
antiandrogen withdrawal. III. Evaluate the proportion of patients with circulating prostate
cancer cells identified by reverse transcriptase-polymerase chain reaction (rt-PCR). IV.
Determine whether rt-PCR positively correlates with response. V. Compare the likelihood of
response to these regimens in patients whose prior hormonal therapy consisted of initial
combined androgen blockage vs. initial monotherapy followed later by an antiandrogen. VI.
Correlate adrenal androgen synthesis suppression, as measured by levels of various adrenal
androgens, with response.

OUTLINE: Randomized study. Patients who develop progressive disease on Arm I cross to Arm
II. Arm I: Antiandrogen Withdrawal. Antiandrogen stopped. Arm II: Antiandrogen Withdrawal
plus Adrenal Androgen Blockade. Antiandrogen stopped; plus Ketoconazole, KCZ;
Hydrocortisone, HC, NSC-10483.

PROJECTED ACCRUAL: Approximately 250 patients will be entered over 3 years to attain 238
eligible patients (including 25-40 minority patients).

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically diagnosed adenocarcinoma of the prostate
Progressive metastatic or regional nodal disease after at least 4 weeks on flutamide,
bicalutamide, or nilutamide, i.e.: Greater than 25% increase in sum of products of
perpendicular diameters of all measurable lesions not previously irradiated OR
Prostate-specific antigen (PSA) at least 5 ng/mL and risen from baseline on at least 2
successive occasions at least 2 weeks apart PSA progression required for "bone only"
disease or disease that responded to androgen deprivation and is negative on imaging scans
at entry Primary testicular androgen suppression with a luteinizing hormone-releasing
hormone (LHRH) analogue plus antiandrogen or by orchiectomy required Intermittent LHRH
analog/antiandrogen therapy resumed at least 4 weeks prior to and continued at time of
entry LHRH analogue continued throughout study in absence of orchiectomy

PATIENT CHARACTERISTICS: Age: Any age Performance status: 0-2 Hematopoietic: Not specified
Hepatic: Bilirubin no greater than 1.5 times normal AST no greater than 3 times normal
Renal: Not specified Other: No active, uncontrolled condition including: Bacterial, viral,
or fungal infection Hyperglycemia Gastric or duodenal ulcer No existing medical condition
requiring systemic corticosteroids (inhaled and topical steroids allowed) No concurrent
use of the following: Terfenadine Astemizole Cisapride

PRIOR CONCURRENT THERAPY: No prior therapy with experimental agents for metastatic disease
Biologic therapy: No prior immunotherapy for metastatic disease Chemotherapy: No prior
estramustine or other chemotherapy for metastatic disease Endocrine therapy: See Disease
Characteristics No prior hormonal therapy for metastatic disease No prior
aminoglutethimide No prior ketoconazole No prior hydrocortisone or other corticosteroids
Prior experimental hormonal therapy requires approval of study chair Radiotherapy: At
least 4 weeks since radiotherapy (8 weeks since strontium therapy) Surgery: Orchiectomy
allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response: PSA

Outcome Time Frame:

q 8 wks, at cross over (if applic), at progression; q 6 mon in f/u

Safety Issue:

No

Principal Investigator

Eric J. Small, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000064708

NCT ID:

NCT00002760

Start Date:

August 1996

Completion Date:

April 2009

Related Keywords:

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

Name

Location

University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128