Prostate CancerPhase 2NCT00027794
Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
A Phase 2 study testing conventional surgery in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 70 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Sep 2001to Jan 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Belgium2 sites
Virga Jesse Hospital
Hasselt, 3500
U.Z. Gasthuisberg
Leuven, B-3000
Italy2 sites
Istituto Scientifico H. San Raffaele
Milan, 20132
Ospedale di Circolo e Fondazione Macchi
Varese, 21100
About this study
Official title: Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study
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.
Read the detailed description
OBJECTIVES:
- 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
- Prostate Cancer
- Being tested
- conventional surgery
- Keywords
- adenocarcinoma of the prostate, stage III prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 2001
- Primary completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Hein van Poppel, MD, PhD, Study chair, University Hospital, Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027794
- Sponsor's protocol ID
- EORTC-30001
- Other IDs
- EORTC-30001
- Status last verified
- Sep 2012
- First submitted
- 7 Dec 2001
- Last updated
- 24 Sep 2012
- Results posted
- No
Publications
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.
PubMed 16624554
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study
- ClinicalTrials.gov ID
- NCT00027794
- Acronym / sponsor ID
- EORTC-30001
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage III prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Sep 2001
- Primary completion
- Jan 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
- Results publication: PubMed 16624554Van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hein van Poppel, MD, PhD study chair
University Hospital, Gasthuisberg
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing conventional surgery in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Italy, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00027794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.