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Phase III Comparison of Early vs Delayed Endocrine Manipulation (Orchiectomy or LHRH Agonist Therapy) in Previously Untreated Patients with Nonmetastatic Asymptomatic Carcinoma of the Prostate

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

Alternate Title

Early Compared With Delayed Hormone Therapy in Treating Patients With Nonmetastatic Prostate Cancer

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed80 and underEORTC-30891

Objectives

I.  Compare, in a randomized Phase III multi-institutional setting, 
symptom-free survival time of patients with asymptomatic carcinoma of the 
prostate (T0-4, N0-2, M0) not suited for local curative treatment who are 
randomly assigned to immediate vs. delayed endocrine intervention (orchiectomy 
or LHRH agonist therapy).

II.  Compare the overall survival of these two groups of patients.

III.  Compare the time to first evidence of distant progression (N4 or M1) of 
these two treatment groups.

IV.  Evaluate the prognostic significance of pretreatment laboratory data and 
monitor these parameters following endocrine therapy.

V.  Study the prognosis of various sub-groups of patients stratified according 
to performance status, local tumor extent, nodal status, and choice of 
endocrine treatment.

Entry Criteria

Disease Characteristics:


Histologically or cytologically proven carcinoma of the
prostate

Stage T0-4, N0-2 (smaller than 5 cm), M0 disease not amenable
to potentially curative local treatment (radical prostatectomy
or radiotherapy)

  Nodal status determined by CT or ultrasound and preferably
  confirmed cytologically

No more than 1 month since diagnosis

Asymptomatic aside from disturbance in voiding

No ureteral obstruction or other evidence of locally advanced
disease that could lead to fatal complications (e.g., rectal
stenosis, thrombosis of pelvic veins) if left untreated

Willing to undergo orchiectomy or receive continuous LHRH
analogue treatment


Prior/Concurrent Therapy:


Biologic therapy:
  No prior therapy

Chemotherapy:
  No prior therapy

Endocrine therapy:
  No prior endocrine therapy

Radiotherapy:
  No prior radiotherapy

Surgery:
  No prior radical prostatectomy
  TURP for voiding difficulties allowed


Patient Characteristics:


Age:
  No greater than 80

Performance status:
  WHO 0 or 1

Life expectancy:
  At least 6 months

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Other:
  No second malignancy within 10 years except treated basal
  cell carcinoma of the skin


Expected Enrollment

Approximately 750 patients will be entered in order to achieve the required 
612 evaluable patients.  A 6-year accrual period is anticipated.

Outline

Randomized study.  All patients select the type of endocrine therapy they are 
ultimately to receive prior to randomization.

Arm I:  Immediate Endocrine Therapy.  Orchiectomy or LHRH Agonist Therapy plus 
(initially) Antiandrogen Therapy.  Buserelin, BSRL; Cyproterone acetate, CPTR, 
NSC-81430.  Treatment initiated within 1 month of randomization.

Arm II:  Delayed Endocrine Therapy.  Orchiectomy or LHRH Therapy plus 
(initially) Antiandrogen Therapy.  BSRL; CPTR.  Treatment delayed until onset 
of symptoms.

Published Results

Studer UE, Collette L, Whelan P, et al.: Using PSA to guide timing of androgen deprivation in patients with T0-4 N0-2 M0 prostate cancer not suitable for local curative treatment (EORTC 30891). Eur Urol 53 (5): 941-9, 2008.[PUBMED Abstract]

Studer UE, Collette L, Whelan P, et al.: PSA decline from baseline is not a prognostic factor for outcome in hormonally treated patients with T0-4N0M0 prostate cancer not suitable for local treatment with curative intent treated in EORTC 30891. [Abstract] American Urological Association: Annual Meeting, May 20-25, 2006, Atlanta, GA A-664, 2006.

Studer UE, Collette L, Whelan P: Patients with T0-4N0M0 prostate cancer not suitable for local treatment with curative intent (EORTC 30891): which subgroup needs or does not need immediate treatment? [Abstract] American Urological Association: Annual Meeting, May 20-25, 2006, Atlanta, GA A-1592, 2006.

Studer UE, Collette L, Whelan P, et al.: Baseline PSA and PSA doubling time predict the risk of objective progression and death in patients with T0-4 N0-2 M0 prostate cancer on watchful waiting. [Abstract] American Urological Association: Annual Meeting, May 20-25, 2006, Atlanta, GA A-665, 2006.

Studer UE, Whelan P, Albrecht W, et al.: Immediate or deferred androgen deprivation for patients with prostate cancer not suitable for local treatment with curative intent: European Organisation for Research and Treatment of Cancer (EORTC) Trial 30891. J Clin Oncol 24 (12): 1868-76, 2006.[PUBMED Abstract]

Studer UE, Switzerland B, Whelan P, et al.: Immediate versus deferred androgen deprivation in patients with asymptomatic prostate cancer T0-4 N0-2 M0 not suitable for local definitive treatment. [Abstract] J Urol 173 (Suppl 4): A-1659, 2005.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Urs Studer, MD, Protocol chair
Ph: 41-31-632-3621

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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