Active Control of Prostatic Cancer With Criteria of Latence (SURACAP)
This study has been completed.
Sponsor:
Clinique Mutualiste Chirurgicale de la Loire
Information provided by:
Clinique Mutualiste Chirurgicale de la Loire
ClinicalTrials.gov Identifier:
NCT00921258
First received: June 12, 2009
Last updated: July 20, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Procedure: prostate biopsy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Active Control of Prostatic Cancer With Criteria of Latence. Impact on Specific 10 Years Survival. |
Resource links provided by NLM:
Further study details as provided by Clinique Mutualiste Chirurgicale de la Loire:
Primary Outcome Measures:
- Evaluates specific survival to 10 years [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate acceptation of 2nd biopsy to confirm latent cancer [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- To evaluate global survival of patient in control [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- To evaluate the survival of patient with a secondary active treatment after a control period [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
- To evaluate delay to secondary treatment after a period control [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
- To evaluate survival rate without biological or clinical progression of cancer [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
- To evaluate quality of life [ Time Frame: 10 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2007 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
control group
Patient with latent prostate cancer who agree to be controled instead of to be treated
|
Procedure: prostate biopsy
patient of control group will have :
|
Detailed Description:
This study concern the active control during 10 years of patient with latent prostate cancer who accept not be treated immediately.
Eligibility| Ages Eligible for Study: | 18 Years to 74 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
patients with latent prostate cancer who agree to be controlled instead of to be immediately treated for this cancer
Criteria
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921258
Locations
| France | |
| R Azzouzi | |
| Angers, France | |
| Jean-Louis DAVIN | |
| Avignon, France | |
| Henri BENSADOUN | |
| Caen, France, 14000 | |
| SALOMON | |
| Creteil, France | |
| René GASCHIGNARD | |
| La Roche Sur Yon, France, 85000 | |
| RUFFION | |
| Lyon, France, 69000 | |
| Eric LECHEVALLIER | |
| Marseille, France, 13 385 | |
| P. ROSSI | |
| Marseille, France, 13000 | |
| Xavier REBILLARD | |
| Montpellier, France | |
| RIGAUD Jérôme | |
| Nantes, France | |
| Christophe AVANCES | |
| NiMES, France | |
| IRANI Jacques | |
| Poitiers, France, 86000 | |
| P Colloby | |
| Pontoise, France | |
| Clinique Mutualiste Chirurgicale | |
| Saint-etienne, France, 42055 | |
| SOULIE Michel | |
| Toulouse, France, 31059 | |
Sponsors and Collaborators
Clinique Mutualiste Chirurgicale de la Loire
Investigators
| Principal Investigator: | Nicolas MOTTET, Dr | Clinique Mutualiste Chirurgicale |
More Information
No publications provided
| Responsible Party: | Dr Nicolas MOTTET, Clinique Mutualiste Chirurgicale de la Loire |
| ClinicalTrials.gov Identifier: | NCT00921258 History of Changes |
| Other Study ID Numbers: | 0700043, 2007-A00871-52 |
| Study First Received: | June 12, 2009 |
| Last Updated: | July 20, 2011 |
| Health Authority: | France: Direction Générale de la Santé |
Keywords provided by Clinique Mutualiste Chirurgicale de la Loire:
|
latent prostate cancer Patient with latent prostate cancer PSA ≤ 10 ng/ml Clinical stage T1c or T2a Patient who accept just be control |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013