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A Phase II Trial of Early Medical Adrenalectomy for "D0.5" Prostate Cancer


Phase 2
N/A
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Phase II Trial of Early Medical Adrenalectomy for "D0.5" Prostate Cancer


OBJECTIVES: I. Determine the Prostate-Specific Antigen (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.

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.

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

Inclusion 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)

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

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective Response Rate (ORR) for Treatment Arm

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Mayer Fishman, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

MCC-12219

NCT ID:

NCT00006371

Start Date:

May 2000

Completion Date:

December 2001

Related Keywords:

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

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612