Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
NCT ID: NCT00027794
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2001-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Phase II trial to study the effectiveness of radical prostatectomy in treating patients who have locally advanced prostate cancer.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Determine the success rate of radical prostatectomy in patients with locally advanced adenocarcinoma of the prostate.
* Determine the serious toxic event rate of this surgery in these patients.
* Determine the pN status of patients treated with this surgery.
* Determine the percentage of patients found to have organ-confined tumors (pT2) after undergoing this surgery.
* Determine the 2-year prostate-specific antigen-free survival rate of patients treated with this surgery.
* Determine the surgical morbidity rates of patients treated with this surgery.
OUTLINE: This is a multicenter study.
Patients undergo limited pelvic lymphadenectomy and then radical retropubic prostatectomy.
Patients who are found to have pN-positive disease receive further treatment according to the investigator's discretion. Patients with pN0 disease are followed every 3 months for 1 year and then every 4 months for 1 year.
PROJECTED ACCRUAL: A total of 32-74 patients will be accrued for this study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
conventional surgery
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
70 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hein van Poppel, MD, PhD
Role: STUDY_CHAIR
University Hospital, Gasthuisberg
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Virga Jesse Hospital
Hasselt, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Istituto Scientifico H. San Raffaele
Milan, , Italy
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Martin Faculty Hospital
Martin, , Slovakia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EORTC-30001
Identifier Type: -
Identifier Source: secondary_id
EORTC-30001
Identifier Type: -
Identifier Source: org_study_id