Prostate CancerSURACAPNCT00921258
Active Control of Prostatic Cancer With Criteria of Latence
An observational study of Prostate Cancer, run by Clinique Mutualiste Chirurgicale de la Loire at 15 sites in France.
Trial summary
This study concern a prospective cohort pf patients with latent prostate cancer. We study the specific survival at 10 years of patients who accept an active control.Patients inclusion are realized in 2 stages: patient with inclusion criteria (PSA < 10 ng/ml, clinical stage T1c or T2a, Gleason < or = 6) are registered… Read more about this study
- Who is it for?
- Ages 18 to 74 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- prostate biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 15 sitesFrance
- Study dates
- Dec 2007to Dec 2013
- Phase
- Observational
- 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 74 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: patients with latent prostate cancer who agree to be controlled instead of to be immediately treated for this cancer
Who may be able to join
- patient with a latent prostatic cancer
- aged less 75 years old,
- life expectation higher than 10 years
- Clinic statue T1c or T2a
- with a seric PSA (prostatic specific antigen)smaller than 10ng/ml
- more than 10 biopsy cores samples
Show all 9Show fewer
- patient with less than 3 cores samples with tumor and none care sample with more than 3mm of tumor
- Gleason score inferior at 7
- patient's agreement about project and a second biopsy which will include definitive patient: realized 3 months after the first and having: 14 biopsy cores samples (10 like previously and 4 more specific: taking around the positives initials biopsies), less than 3 cores samples with tumor, ,any cores samples with more than 3mm of tumor, a Gleason score superior at 7.
Who cannot join
- patient aged 75 years old and more
- no patient's agreement
- lack of understanding of plan
- patient with guardianship
- life expectation smaller than 10 years
- patient with an other cancer less than 5 years
Show all 15Show fewer
- Local clinical statue greater than T2a
- seric PSA higher than 10ng/ml
- less than 10 biopsies
- more than 2 positives biopsies during the first intervention
- 3 cores samples with more than 3mm of tumor
- 4th grade on the biopsies
- patient's refuse to realize the second biopsies
- patient who ask a treatment after the first medical examination
- patient with less 4 special biopsies around the previously initial cores samples or more than 2 positives biopsies or biopsies with more than 3mm of tumor or patient having a 4 grade on biopsies, during the second medical examination.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
R Azzouzi
Angers
Jean-Louis DAVIN
Avignon
Henri BENSADOUN
Caen, 14000
SALOMON
Créteil
René GASCHIGNARD
La Roche-sur-Yon, 85000
RUFFION
Lyon, 69000
Eric LECHEVALLIER
Marseille, 13 385
P. ROSSI
Marseille, 13000
Xavier REBILLARD
Montpellier
RIGAUD Jérôme
Nantes
Christophe AVANCES
Nîmes
IRANI Jacques
Poitiers, 86000
P Colloby
Pontoise
Clinique Mutualiste Chirurgicale
Saint-Etienne, 42055
SOULIE Michel
Toulouse, 31059
About this study
Official title: Active Control of Prostatic Cancer With Criteria of Latence. Impact on Specific 10 Years Survival.
This study concern a prospective cohort pf patients with latent prostate cancer. We study the specific survival at 10 years of patients who accept an active control.Patients inclusion are realized in 2 stages:
- patient with inclusion criteria (PSA < 10 ng/ml, clinical stage T1c or T2a, Gleason < or = 6) are registered if they accept a second prostate biopsy in a 3 months delay
- after analyse of second biopsy in central laboratory and confirmation of latent prostate biopsy, patients are included if they accept active control Included patients will have 1 biopsy by years the first two years and then 1 biopsy each 2 years during 8 years.
If progression of cancer happens during the 10 years control, active control will be stopped and patient will be treated by surgery and chemotherapy.
Read the detailed description
This study concern the active control during 10 years of patient with latent prostate cancer who accept not be treated immediately.
- Conditions
- Prostate Cancer
- Being tested
- prostate biopsy
- Keywords
- latent prostate cancer, Patient with latent prostate cancer, PSA ≤ 10 ng/ml, Clinical stage T1c or T2a, Patient who accept just be control
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prostate biopsyProcedure or surgery
patient of control group will have :
- 1 prostate biopsy 3 months after diagnostic biopsy
- 1 prostate biopsy each year during 2 years
- 1 prostate biopsy each 2 years during 8 years
| Study group | Role | What they receive |
|---|---|---|
| control group | Patient with latent prostate cancer who agree to be controled instead of to be treated Receives: Procedure: prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluates specific survival to 10 years
Measured: 10 years
Secondary outcomes (6)
To evaluate acceptation of 2nd biopsy to confirm latent cancer
Measured: 10 years
To evaluate global survival of patient in control
Measured: 10 years
To evaluate the survival of patient with a secondary active treatment after a control period
Measured: 10 years
To evaluate delay to secondary treatment after a period control
Measured: 10 years
To evaluate survival rate without biological or clinical progression of cancer
Measured: 10 years
To evaluate quality of life
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startDec 2007
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Financial problem (not enough budget to continue the study)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Mutualiste Chirurgicale de la Loire
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas MOTTET, Dr, Principal investigator, Clinique Mutualiste Chirurgicale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921258
- Sponsor's protocol ID
- 0700043
- Other IDs
- 2007-A00871-52
- Acronym
- SURACAP
- Status last verified
- Jun 2015
- First submitted
- 12 Jun 2009
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Control of Prostatic Cancer With Criteria of Latence. Impact on Specific 10 Years Survival.
- ClinicalTrials.gov ID
- NCT00921258
- Acronym / sponsor ID
- SURACAP / 0700043
- Conditions
- Prostate Cancer
- Keywords
- latent prostate cancer, Patient with latent prostate cancer, PSA ≤ 10 ng/ml, Clinical stage T1c or T2a, Patient who accept just be control
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Financial problem (not enough budget to continue the study)
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Clinique Mutualiste Chirurgicale de la LoireUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Jun 2009 (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.
This study concern a prospective cohort pf patients with latent prostate cancer. We study the specific survival at 10 years of patients who accept an active control.Patients inclusion are realized in 2 stages:
- patient with inclusion criteria (PSA < 10 ng/ml, clinical stage T1c or T2a, Gleason < or = 6) are registered if they accept a second prostate biopsy in a 3 months delay
- after analyse of second biopsy in central laboratory and confirmation of latent prostate biopsy, patients are included if they accept active control Included patients will have 1 biopsy by years the first two years and then 1 biopsy each 2 years during 8 years.
If progression of cancer happens during the 10 years control, active control will be stopped and patient will be treated by surgery and chemotherapy.
Detailed description
This study concern the active control during 10 years of patient with latent prostate cancer who accept not be treated immediately.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| control group | – | Procedure: prostate biopsyPatient with latent prostate cancer who agree to be controled instead of to be treated |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with latent prostate cancer who agree to be controlled instead of to be immediately treated for this cancer
Key inclusion criteria (9 listed)
- patient with a latent prostatic cancer
- aged less 75 years old,
- life expectation higher than 10 years
- Clinic statue T1c or T2a
- with a seric PSA (prostatic specific antigen)smaller than 10ng/ml
Key exclusion criteria (15 listed)
- patient aged 75 years old and more
- no patient's agreement
- lack of understanding of plan
- patient with guardianship
- life expectation smaller than 10 years
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 |
|---|---|---|
| prostate biopsypatient of control group will have : * 1 prostate biopsy 3 months after diagnostic biopsy * 1 prostate biopsy each year during 2 years * 1 prostate biopsy each 2 years during 8 years | Procedure or surgery | control group |
Primary outcome
Evaluates specific survival to 10 years
Time frame: 10 years
6 secondary outcomes
To evaluate acceptation of 2nd biopsy to confirm latent cancer
Time frame: 10 years
To evaluate global survival of patient in control
Time frame: 10 years
To evaluate the survival of patient with a secondary active treatment after a control period
Time frame: 10 years
To evaluate delay to secondary treatment after a period control
Time frame: 10 years
To evaluate survival rate without biological or clinical progression of cancer
Time frame: 10 years
To evaluate quality of life
Time frame: 10 years
Results and safety
The study was stopped early (reason given: Financial problem (not enough budget to continue the study)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
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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.
Nicolas MOTTET, Dr principal investigator
Clinique Mutualiste Chirurgicale
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Clinique Mutualiste Chirurgicale de la Loire at 15 sites 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 9 inclusion and 15 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: stopped early, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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.
Are results available for this study?
The study was stopped early (reason given: Financial problem (not enough budget to continue the study)). Results are not available in the source record.
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.
What does the primary outcome measure?
Evaluates specific survival to 10 years (time frame: 10 years). 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 4 Jun 2015.