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

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ClinicalTrials.gov Identifier: NCT01819285
Recruitment Status : Completed
First Posted : March 27, 2013
Last Update Posted : March 27, 2013
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Study Description
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Brief Summary:

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 luteinizing hormone releasing hormone (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.


Condition or disease Intervention/treatment Phase
Neoplasm, Prostate Procedure: Immediate Orchiectomy or depot LHRH Procedure: Delayed Orchiectomy or depot LHRH Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 985 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 1990
Actual Primary Completion Date : July 2004
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Gonadorelin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Immediate Endocrine Therapy
Immediate Endocrine Therapy. Orchiectomy or LHRH Agonist Therapy plus (initially) Antiandrogen Therapy. Buserelin (BSRL); Cyproterone acetate (Androcur) (CPTR), Cyproterone acetate (Androcur)(NSC-81430). Treatment initiated within 1 month of randomization.
 Procedure: Immediate Orchiectomy or depot LHRH
Experimental: Delayed Endocrine Therapy
Orchiectomy or LHRH Therapy plus (initially) Antiandrogen Therapy. BSRL; CPTR. Treatment delayed until onset of symptoms.
 Procedure: Delayed Orchiectomy or depot LHRH


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 13 years from first patient in ]

Secondary Outcome Measures :
  1. Overall symptom free survival time [ Time Frame: 13 years from first patient in ]
  2. Time until first evidence of distant progression [ Time Frame: 13 years from first patient in ]
  3. Prognostic importance of pretreatment laboratory data [ Time Frame: 13 years from first patient in ]
    prostate cancer mortality and overall mortality according to pretreatment laboratory data

  4. Prognosis of particular sub-groups [ Time Frame: 13 years from first patient in ]
    prostate cancer mortality and overall mortality according to particular sub-groups (following stratification factors): performance status (0 vs 1), the local tumor extent (T0-2 vs T3-4), nodal status (N0 vs N1-2), the choice of hormonal therapy.


Eligibility Criteria
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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically proven, newly diagnosed asymptomatic (with the exception of voiding disturbances) carcinoma of the prostate T0-4 N0-2 M0 which is not suitable for local treatment with curative intent (radical prostatectomy, radiation therapy).
  • All T stages are acceptable (UICC 1982). The stage is determined by rectal palpation.
  • Patients with regional lymph node metastases smaller than 5 cm (N0-2), determined either by CT or ultrasonography, preferable with cytologic confirmation.
  • Life expectancy of at least six months.
  • WHO performance status score 0-1.
  • Informed consent. Patients must be prepared to undergo an orchiectomy or continuous treatment with a depot LHRH analogue.
  • Continuous follow-up until death if possible.

Exclusion Criteria:

  • Other malignancies diagnosed during the last 10 years, apart from treated basal cell carcinoma of the skin.
  • Prostate cancer known for longer than one month before entering the study.
  • Pain caused by the prostate cancer or its metastases.
  • Any previous treatment for prostate cancer (radical prostatectomy, radiation therapy, endocrine treatment, etc.) Note: TUR-P for voiding disturbances is allowed at any time and is not an exclusion criterion.
  • Patients with ureteric obstruction caused by local infiltration of prostatic cancer and other evidence of locally advanced disease which could cause fatal complications if untreated (e.g. rectal stenosis, thrombosis of pelvic veins).
  • Patients with palpable or juxtaregional lymph node metastasis (paraaortic, supraclavicular, inguinal, N3-4).
  • Patients with evidence of distant metastases (bone, lung, liver).
  • Age over 80 years. Performance status WHO score 2, 3 and 4 (any reason).
  • Patient who refuses orchiectomy or longterm subcutaneous implants of LHRH analogue in two monthly intervals.

Expected difficulties with follow-up for any reason.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819285


Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
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Study Chair: Urs Studer, MD University Hospital Inselspital, Berne
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01819285    
Other Study ID Numbers: EORTC-30891
First Posted: March 27, 2013    Key Record Dates
Last Update Posted: March 27, 2013
Last Verified: March 2013
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
Malignant Neoplasm of Prostate
Tumor-node-metastasis (TNM) Staging Regional Lymph Nodes (N0-2)
Not suitable for local treatment with curative intent
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Prostatic Diseases
Prolactin Release-Inhibiting Factors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs