Cancer of the PROSTATEPhase 3PROPENLAPNCT00502723
Multicentric Study Comparing Carcinological and Functional Results of Surgery
A Phase 3 study testing Radical retropubic prostatectomy and Radical laparoscopy prostatectomy in people with Cancer of the PROSTATE, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
National multicentric prospective open study, comparing two current surgical methods: laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Cancer of the PROSTATE
- What is being tested?
- Radical retropubic prostatectomy and Radical laparoscopy prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2007to Jul 2012
- Phase
- Phase 3
- 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 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, old patient of less than 70 years,
- having a prostate cancer proven histologically, requiring a radical prostatectomy.
- Clinical stage T1c and rate of PSA (with 20 ng/ml).
- Osseous scintiscanning and abdomen-pelvic scanner negative.
- Patient informed of the study and its participation.
- Patient affiliated to a social security system.
Who cannot join
- Contra-indication with the surgery or the anaesthesia.
- Antecedent of prostate resection or adenomectomy.
- Antecedent of inguinal hernia treatment.
- Antecedent of deep venous thrombosis of the lower limbs or pulmonary embolism
- Patient privatized of freedom.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier Albert Chenevier Henri Mondor
Créteil, 94000
Claude ABBOU, PU-PH, +33 (0)1.49.81.25.51, claude.abbou@hmn.aphp.fr
About this study
Official title: Prostate Cancer: Multicentric Study Comparing Carcinological and Functional Results of Surgery
National multicentric prospective open study, comparing two current surgical methods: laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.
Read the detailed description
The aim of this study is to show that radical prostatectomy by laparoscopic way could obtain carcinological results not lower than theses with radical retropubic surgery.
- Conditions
- Cancer of the PROSTATE
- Being tested
- Radical retropubic prostatectomy, Radical laparoscopy prostatectomy
- Keywords
- Retropubic Prostatectomy, Surgical Procedures, Laparoscopic
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical retropubic prostatectomyProcedure or surgery
Radical retropubic prostatectomy
Radical laparoscopy prostatectomyProcedure or surgery
Radical laparoscopy prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Radical laparoscopy prostatectomy Receives: Procedure: Radical laparoscopy prostatectomy |
| 1 | Experimental | Radical retropubic prostatectomy Receives: Procedure: Radical retropubic prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.
Measured: during the study
Secondary outcomes (4)
Carcinological (percentage of positive surgical margins, percentage of capsular crossing).
Measured: after the surgical
Functional (urinary continence, sexuality, quality of life)
Measured: at 2 years
per and post operational morbidity
Measured: during the 36 months
economic
Measured: duration and cost of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startDec 2007
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the PROSTATEStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claude ABBOU, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502723
- Sponsor's protocol ID
- K060402
- Acronym
- PROPENLAP
- Status last verified
- Jan 2008
- First submitted
- 17 Jul 2007
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer: Multicentric Study Comparing Carcinological and Functional Results of Surgery
- ClinicalTrials.gov ID
- NCT00502723
- Acronym / sponsor ID
- PROPENLAP / K060402
- Conditions
- Cancer of the PROSTATE
- Keywords
- Retropubic Prostatectomy, Surgical Procedures, Laparoscopic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 18 Jul 2007 (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.
National multicentric prospective open study, comparing two current surgical methods: laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.
Detailed description
The aim of this study is to show that radical prostatectomy by laparoscopic way could obtain carcinological results not lower than theses with radical retropubic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Procedure: Radical laparoscopy prostatectomyRadical laparoscopy prostatectomy |
| 1 | Experimental | Procedure: Radical retropubic prostatectomyRadical retropubic prostatectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male, old patient of less than 70 years,
- having a prostate cancer proven histologically, requiring a radical prostatectomy.
- Clinical stage T1c and rate of PSA (with 20 ng/ml).
- Osseous scintiscanning and abdomen-pelvic scanner negative.
- Patient informed of the study and its participation.
Key exclusion criteria (5 listed)
- Contra-indication with the surgery or the anaesthesia.
- Antecedent of prostate resection or adenomectomy.
- Antecedent of inguinal hernia treatment.
- Antecedent of deep venous thrombosis of the lower limbs or pulmonary embolism
- Patient privatized of freedom.
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 |
|---|---|---|
| Radical retropubic prostatectomyRadical retropubic prostatectomy | Procedure or surgery | 1 |
| Radical laparoscopy prostatectomyRadical laparoscopy prostatectomy | Procedure or surgery | 2 |
Primary outcome
laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.
Time frame: during the study
4 secondary outcomes
Carcinological (percentage of positive surgical margins, percentage of capsular crossing).
Time frame: after the surgical
Functional (urinary continence, sexuality, quality of life)
Time frame: at 2 years
per and post operational morbidity
Time frame: during the 36 months
economic
Time frame: duration and cost of hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
Related trials for Cancer of the PROSTATE
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MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
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Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Claude ABBOU, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radical retropubic prostatectomy and Radical laparoscopy prostatectomy in people with Cancer of the PROSTATE, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claude ABBOU, PU-PH (33 (0)1.49.81.25.51, claude.abbou@hmn.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer. (time frame: during the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2012.