NCT00027794

Brief Summary

RATIONALE: Radical prostatectomy may be an effective treatment for locally advanced prostate cancer. PURPOSE: Phase II trial to study the effectiveness of radical prostatectomy in treating patients who have locally advanced prostate cancer.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2001

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

3.3 years

First QC Date

December 7, 2001

Last Update Submit

September 20, 2012

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage III prostate cancer

Interventions

conventional surgeryPROCEDURE

Eligibility Criteria

AgeUp to 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Unilateral cT3a, cN0, M0 * Well or moderately differentiated tumor * Gleason score no greater than 7 (4 plus 3 or 3 plus 4) * Total serum prostate-specific antigen no greater than 20 ng/mL (Hybritech equivalent) PATIENT CHARACTERISTICS: Age: * 70 and under Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * WBC greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 9 g/dL Hepatic: * Bilirubin no greater than 1.5 times normal * ALT or AST less than 3 times normal * PT and PTT normal Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy * No myocardial infarction within the past 6 months Pulmonary: * No gross abnormalities on chest x-ray Other: * No other disease that would preclude surgery * No other prior malignancy except adequately treated basal cell skin cancer * No other concurrent primary malignancy * No psychological, familial, sociological, or geographical condition that would preclude compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * No prior hormonal therapy that would affect assessment of clinical T staging, margin positivity, or definitive pT staging Radiotherapy: * No prior pelvic radiotherapy that would affect surgical resectability and perioperative morbidity Surgery: * No prior surgery in the small pelvis (vascular surgery, mesh graft hernia repair, any surgery for benign prostatic hypertrophy, or transurethral resection of prostate) that would preclude prostatectomy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

Virga Jesse Hospital

Hasselt, 3500, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Istituto Scientifico H. San Raffaele

Milan, 20132, Italy

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Martin Faculty Hospital

Martin, 03659, Slovakia

Location

Related Publications (1)

  • Van Poppel H, Vekemans K, Da Pozzo L, Bono A, Kliment J, Montironi R, Debois M, Collette L. Radical prostatectomy for locally advanced prostate cancer: results of a feasibility study (EORTC 30001). Eur J Cancer. 2006 May;42(8):1062-7. doi: 10.1016/j.ejca.2005.11.030. Epub 2006 Apr 18.

    PMID: 16624554RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Hein van Poppel, MD, PhD

    University Hospital, Gasthuisberg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2001

First Posted

January 27, 2003

Study Start

September 1, 2001

Primary Completion

January 1, 2005

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

SL(1)BE(2)IT(2)