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

Alternate Title

Hormone Therapy in Treating Patients With Metastatic Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed Not specified NCI, Pharmaceutical / Industry MSKCC-98092 ZENECA-7054US/0007, NCI-G99-1494

Objectives

I.   Determine the time to disease progression of asymptomatic metastatic 
prostate cancer patients treated with bicalutamide in combination with 
castration as second line therapy.

II.  Compare time to initiation of next line therapy, PSA response, time to 
PSA progression, and changes in performance status of the patients treated 
with these regimens.

III. Compare safety and tolerability of these regimens in these patients.

Entry Criteria

Disease Characteristics:

Histologically diagnosed refractory metastatic prostate cancer with bone
involvement

Documented PSA progression and increase in PSA level

Prior treatment for stage IV disease with orchiectomy or LHRH analog with or
without antiandrogen required

Testosterone level less than 50 ng/dL

No pain caused by disease

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No prior or concurrent chemotherapy

Endocrine therapy:
 See Disease Characteristics
 At least 30 days since prior flutamide or cyproterone acetate as first line
  therapy
 At least 60 days since prior nilutamide as first line therapy
 No prior second line hormonal therapy

Radiotherapy:
 No prior or concurrent palliative radiotherapy

Surgery:
 Prior orchiectomy required

Other:
 At least 6 months since prior bicalutamide (except for neoadjuvant or
  adjuvant therapy which did not exceed 6 months duration)

Patient Characteristics:

Age:
 Not specified

Performance status:
 ECOG 0-1

Life expectancy:
 At least 3 months

Hematopoietic:
 Not specified

Hepatic:
 Not specified

Renal:
 Not specified

Other:
 No other severe medical condition
 No known hypersensitivity to bicalutamide or its components
 Fertile patients must use effective contraception during and for 3 months
  after study

Expected Enrollment

This study will accrue 360 patients within 1 year.

Outline

This is a randomized, double blind, parallel group, multicenter study.  
Patients are randomized to receive bicalutamide or placebo.

Following castration, patients receive oral bicalutamide or placebo once 
daily.  Patients continue treatment in the absence of disease progression.

Patients are followed every 3 months until death.
 

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Howard Scher, MD, Protocol chair		Ph: 646-422-4330; 800-525-2225 Email: scherh@mskcc.org