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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed any age MRC-PROST EU-90038

Objectives

I.  Determine the overall and symptom-free survival of patients with newly 
diagnosed, locally advanced or asymptomatic metastatic prostate cancer treated 
with immediate vs. delayed hormone therapy (orchiectomy or LHRH analogue).

II.  Determine whether immediate hormonal therapy reduces the risk of 
complications, such as pathologic fractures or paraplegia, and the incidence 
of urethral obstruction requiring subsequent transurethral resection.

III.  Determine the incidence of death from nonmalignant causes prior to the 
development of symptoms or complications requiring therapy in patients 
randomized to delayed therapy.

Entry Criteria

Disease Characteristics:

Histologically confirmed, newly diagnosed adenocarcinoma of the
prostate with no clear requirement for or contraindication to
immediate hormonal therapy

Locally advanced (T2-4) or asymptomatic metastatic (any T, M1)
  M1 disease defined as any of the following:
     Increased uptake on bone scan consistent with
     metastatic disease and for which radiology confirms a
     metastasis or excludes nonmetastatic causes

     Typical metastasis on x-ray (full skeletal survey not
     required if bone scan is performed)

     Serum acid phosphatase greater than twice the upper limit
     of normal on at least 2 successive occasions
        One measurement must be at least 48 hours after
        instrumentation or rectal exam

        Prostate-specific antigen considered indicative of
        metastasis

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  No prior hormonal therapy

Radiotherapy:
  Prior or planned local radiotherapy allowed

Surgery:
  Prior or planned transurethral prostatic resection allowed

Patient Characteristics:

Age:
  Any age

Performance status:
  0-2

Life expectancy:
  At least 1 year

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Other:
  No second malignancy except basal cell skin cancer

Expected Enrollment

Interim analyses are performed at 6-month intervals and accrual will continue 
until results on one arm are clearly superior or until as large as possible a 
number of patients has been entered.

Outline

Randomized study.

Arm I:  Immediate Hormonal Monotherapy.  Subcapsular or total orchiectomy; or 
LHRH Analogue Therapy with Goserelin, ZDX, NSC-606864; or Leuprolide, LEUP, 
NSC-377526.  Choice of treatment is at the option of the physician and patient.

Arm II:  Delayed Hormonal Monotherapy.  As in Arm I, but delayed until disease 
progression dictates intervention.

Trial Contact Information

Trial Lead Organizations

Medical Research Council's Working Party on Leukemia in Adults and Children

David Kirk, MD, FRCS, Protocol chair		Ph: 44-141-339-8822