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

Neoplasm, Prostate Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819285
• Other study ID #: EORTC-30891
• Status: Completed
• Phase: Phase 3
• First received: March 18, 2013
• Last updated: March 22, 2013
• Start date: February 1990
• Est. completion date: September 2010

Study information

• Verified date: March 2013
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyBelgium: Federal Agency for Medicinal Products and Health ProductsCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: Ethics CommitteeMalta: Medicines AuthorityNorway: Norwegian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: National Pharmacy and Medicines InstituteRussia: Ministry of Health of the Russian FederationSlovak Republic: Ethics CommitteeSpain: Agencia Española de Medicamentos y Productos SanitariosSwitzerland: SwissmedicNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Turkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 985
• Est. completion date: September 2010
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Neoplasm, Prostate
• Prostatic Neoplasms

Intervention

Procedure:
• Immediate Orchiectomy or depot LHRH

• Delayed Orchiectomy or depot LHRH

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		13 years from first patient in	No
Secondary	Overall symptom free survival time		13 years from first patient in	No
Secondary	Time until first evidence of distant progression		13 years from first patient in	No
Secondary	Prognostic importance of pretreatment laboratory data	prostate cancer mortality and overall mortality according to pretreatment laboratory data	13 years from first patient in	No
Secondary	Prognosis of particular sub-groups	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.	13 years from first patient in	No

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