Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2026-01-31 @ 10:24 AM
Study NCT ID:
NCT04269512
Status:
RECRUITING
Last Update Posted:
2023-04-12
First Post:
2020-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Lymphnode Dissection in Men With Prostate Cancer Treated With Radical Prostatectomy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008197', 'term': 'Lymph Node Excision'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3650}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2020-02-05', 'studyFirstSubmitQcDate': '2020-02-12', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PSA recurrence rate', 'timeFrame': '36 months after surgery', 'description': 'The PSA recurrence rate in patients with intermediate risk prostate cancer treated with radical prostatectomy with or without additional lymph node dissection at three years of follow up (PSA recurrence: PSA value ≥ 0.2 ng / ml).'}], 'secondaryOutcomes': [{'measure': 'Incidence of lymphoceles and complications', 'timeFrame': '6 months after surgery', 'description': '(Clavien classification)'}, {'measure': 'quality of life including continence and potency', 'timeFrame': '6, 12, 24, 36 months after surgery', 'description': 'Questionnaire Expanded prostate cancer index composite (EPIC-26)'}, {'measure': 'metastasis-free survival', 'timeFrame': '36 months', 'description': 'diagnosis of metastasis after prostatectomy by radiological assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostatectomy', 'lymphadenectomy'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.martini-klinik.de', 'label': 'Homepage'}]}, 'descriptionModule': {'briefSummary': 'Currently, lymph node dissection is standard of care during prostatectomy of intermediate risk tumors at the Martini Clinic. It allows the assessment of possible but unlikely lymph nodes metastases. In case of lymph node metastasis, depending on the number of affected lymph nodes, an adjuvant radiation with or without additional hormone therapy may be discussed in order to stop or delay further progression of the disease.\n\nSince the procedure carries additional risks, it is controversial. The risks include prolonged surgery duration, injury of vessels and nerves, as well as disorders of lymphatic circulation after surgery. Moreover, formation of lymphoceles (accumulation of lymph fluid in the tissue) are common, which may result in soft tissue swelling, thrombosis, inflammation and additional surgical procedures.\n\nTherefore, the aim of this study is to evaluate whether the removal of the lymph nodes during prostatectomy positively influences the course of the disease in patients with intermediate risk prostate cancer, or if the lymph node dissection does not have any influence on the recurrence of the disease and therefore further therapies.\n\nIn this case, the omission of lymph node dissection may avoid an unnecessary expansion of the operation and the potentially associated side effects linked to it. This is particularly of interest considering the rapidly advancing technical possibilities, both in imaging and in the treatment of prostate cancer, since this enables an earlier and more individual intervention in the case of recurrence.', 'detailedDescription': 'The significance of lymph node dissection in radical prostatectomy has not been conclusively clarified. If a radical prostatectomy is planned, the question occurs if the additional pelvic lymph node dissection (LND) is justified and to what extent it should be performed (limited LND, standard LND or extended LND). On the one hand, the detection of lymph node metastases is associated with a significantly worse course of the tumor disease and requires immediate or delayed hormone-ablative therapy. On the other hand, the lymph node dissection is associated with risks (lymphoceles, thromboses, lymphedema), so that the indication in negative lymph node findings appears questionable. It must be weighed between the diagnostic advantage and the possibility of increased morbidity due to the lymphadenectomy. For localized intermediate risk prostate cancer (PSA\\> 10 ng / ml - 20 ng / ml or Gleason score 7 or cT category 2b ), there are currently no recommendations for performing a lymph node dissection during prostatectomy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Prostate Cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* localized intermediate risk prostate cancer (intermediate risk (PSA\\> 10 ng / ml - 20 ng / ml or Gleason score 7 or cT category 2b)\n* scheduled for open radical prostatectomie or DaVinci prostatectomie\n\nExclusion Criteria:\n\n* American Society of Anesthesiology Classification\\> 3\n* Existing contraindications for performing a lymph node dissection\n* Neoadjuvant hormone therapy'}, 'identificationModule': {'nctId': 'NCT04269512', 'acronym': 'PREDICT', 'briefTitle': 'Role of Lymphnode Dissection in Men With Prostate Cancer Treated With Radical Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Martini-Klinik am UKE GmbH'}, 'officialTitle': 'Prospective Randomized Trial to Evaluate the Prognostic Role of Lymphnode Dissection in Men With Prostate Cancer Treated With Radical Prostatectomy (Predict-Study)', 'orgStudyIdInfo': {'id': 'PREDICT_MK2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'extended lymph node dissection', 'description': 'Patients randomized to arm A undergo bilateral lymph node dissection in the pelvic area as part of prostatectomy. At least 10 lymph nodes must be removed.', 'interventionNames': ['Procedure: lymph node dissection']}, {'type': 'NO_INTERVENTION', 'label': 'standard without lymph node dissection', 'description': 'Application of standardized surgical technique without extensive lymph node dissection. If, contrary to expectation, intraoperative suspicion of lymphogenic metastasis results, a lymph node dissection is performed and the patient is excluded from the study (freedom of the surgeon).'}], 'interventions': [{'name': 'lymph node dissection', 'type': 'PROCEDURE', 'description': 'At least 10 lymph nodes must be removed.', 'armGroupLabels': ['extended lymph node dissection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Markus Graefen, Professor', 'role': 'CONTACT', 'email': 'graefen@uke.de', 'phone': '+4904741051300'}, {'name': 'Anke Renter', 'role': 'CONTACT', 'email': 'renter@uke.de', 'phone': '+49047410533115'}], 'facility': 'Martini-Klinik am UKE GmbH', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Markus Graefen, Prof.', 'role': 'CONTACT', 'email': 'graefen@uke.de', 'phone': '+49 (0)40 7410 53115'}, {'name': 'Jonas Ekrutt, Dr.', 'role': 'CONTACT', 'email': 'j.ekrutt@uke.de', 'phone': '+49 (0)40 7410 53115'}], 'overallOfficials': [{'name': 'Markus Graefen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Martini-Klinik am UKE GmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}