Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-02 @ 11:44 AM
Study NCT ID:
NCT00921258
Status:
TERMINATED
Last Update Posted:
2015-06-04
First Post:
2009-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Active Control of Prostatic Cancer With Criteria of Latence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'whyStopped': 'Financial problem (not enough budget to continue the study)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-03', 'studyFirstSubmitDate': '2009-06-12', 'studyFirstSubmitQcDate': '2009-06-15', 'lastUpdatePostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluates specific survival to 10 years', 'timeFrame': '10 years'}], 'secondaryOutcomes': [{'measure': 'To evaluate acceptation of 2nd biopsy to confirm latent cancer', 'timeFrame': '10 years'}, {'measure': 'To evaluate global survival of patient in control', 'timeFrame': '10 years'}, {'measure': 'To evaluate the survival of patient with a secondary active treatment after a control period', 'timeFrame': '10 years'}, {'measure': 'To evaluate delay to secondary treatment after a period control', 'timeFrame': '10 years'}, {'measure': 'To evaluate survival rate without biological or clinical progression of cancer', 'timeFrame': '10 years'}, {'measure': 'To evaluate quality of life', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['latent prostate cancer', 'Patient with latent prostate cancer', 'PSA ≤ 10 ng/ml', 'Clinical stage T1c or T2a', 'Patient who accept just be control'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': '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:\n\n* 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\n* 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.\n\nIf progression of cancer happens during the 10 years control, active control will be stopped and patient will be treated by surgery and chemotherapy.', 'detailedDescription': 'This study concern the active control during 10 years of patient with latent prostate cancer who accept not be treated immediately.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with latent prostate cancer who agree to be controlled instead of to be immediately treated for this cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patient with a latent prostatic cancer\n* aged less 75 years old,\n* life expectation higher than 10 years\n* Clinic statue T1c or T2a\n* with a seric PSA (prostatic specific antigen)smaller than 10ng/ml\n* more than 10 biopsy cores samples\n* patient with less than 3 cores samples with tumor and none care sample with more than 3mm of tumor\n* Gleason score inferior at 7\n* 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.\n\nExclusion Criteria:\n\n* patient aged 75 years old and more\n* no patient's agreement\n* lack of understanding of plan\n* patient with guardianship\n* life expectation smaller than 10 years\n* patient with an other cancer less than 5 years\n* Local clinical statue greater than T2a\n* seric PSA higher than 10ng/ml\n* less than 10 biopsies\n* more than 2 positives biopsies during the first intervention\n* 3 cores samples with more than 3mm of tumor\n* 4th grade on the biopsies\n* patient's refuse to realize the second biopsies\n* patient who ask a treatment after the first medical examination\n* 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."}, 'identificationModule': {'nctId': 'NCT00921258', 'acronym': 'SURACAP', 'briefTitle': 'Active Control of Prostatic Cancer With Criteria of Latence', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Mutualiste Chirurgicale de la Loire'}, 'officialTitle': 'Active Control of Prostatic Cancer With Criteria of Latence. Impact on Specific 10 Years Survival.', 'orgStudyIdInfo': {'id': '0700043'}, 'secondaryIdInfos': [{'id': '2007-A00871-52'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'control group', 'description': 'Patient with latent prostate cancer who agree to be controled instead of to be treated', 'interventionNames': ['Procedure: prostate biopsy']}], 'interventions': [{'name': 'prostate biopsy', 'type': 'PROCEDURE', 'description': 'patient of control group will have :\n\n* 1 prostate biopsy 3 months after diagnostic biopsy\n* 1 prostate biopsy each year during 2 years\n* 1 prostate biopsy each 2 years during 8 years', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'R Azzouzi', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Avignon', 'country': 'France', 'facility': 'Jean-Louis DAVIN', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'Henri BENSADOUN', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Créteil', 'country': 'France', 'facility': 'SALOMON', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '85000', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'René GASCHIGNARD', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '69000', 'city': 'Lyon', 'country': 'France', 'facility': 'RUFFION', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13 385', 'city': 'Marseille', 'country': 'France', 'facility': 'Eric LECHEVALLIER', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13000', 'city': 'Marseille', 'country': 'France', 'facility': 'P. ROSSI', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Xavier REBILLARD', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nantes', 'country': 'France', 'facility': 'RIGAUD Jérôme', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nîmes', 'country': 'France', 'facility': 'Christophe AVANCES', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'IRANI Jacques', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Pontoise', 'country': 'France', 'facility': 'P Colloby', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Clinique Mutualiste Chirurgicale', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'SOULIE Michel', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Nicolas MOTTET, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Mutualiste Chirurgicale'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Mutualiste Chirurgicale de la Loire', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}