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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01819285
Other study ID # EORTC-30891
Secondary ID
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


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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