Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT03457805
Status:
UNKNOWN
Last Update Posted:
2021-01-26
First Post:
2018-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prostatic Artery Embolization in Advanced Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D001748', 'term': 'Urinary Bladder Neck Obstruction'}], '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'}, {'id': 'D014524', 'term': 'Urethral Obstruction'}, {'id': 'D014522', 'term': 'Urethral Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-08-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2018-02-22', 'studyFirstSubmitQcDate': '2018-03-06', 'lastUpdatePostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of Lower Urinary Tract Symptoms', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))'}], 'secondaryOutcomes': [{'measure': 'Reduction of Lower Urinary Tract Symptoms', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))'}, {'measure': 'Reduction of Lower Urinary Tract Symptoms', 'timeFrame': 'Baseline and 6 months', 'description': 'Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))'}, {'measure': 'Reduction of Lower Urinary Tract Symptoms', 'timeFrame': 'Baseline and 12 months', 'description': 'Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))'}, {'measure': 'Occurrence of macroscopic hematuria', 'timeFrame': 'From time of PAE to study completion (1 year)', 'description': 'Assessment of occurrence of hematuria according to CTCAE v.4.03 classification'}, {'measure': 'Reduction of Prostate symptoms', 'timeFrame': 'baseline and 6 weeks', 'description': 'Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))'}, {'measure': 'Reduction of Prostate symptoms', 'timeFrame': 'baseline and 12 weeks', 'description': 'Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))'}, {'measure': 'Reduction of Prostate symptoms', 'timeFrame': 'baseline and 6 months', 'description': 'Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))'}, {'measure': 'Reduction of Prostate symptoms', 'timeFrame': 'baseline and 12 months', 'description': 'Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))'}, {'measure': 'Occurrence of urinary incontinence', 'timeFrame': '6 week after PAE', 'description': 'Assessment of ICS-SF questionnaire'}, {'measure': 'Occurrence of urinary incontinence', 'timeFrame': '12 week after PAE', 'description': 'Assessment of ICS-SF questionnaire'}, {'measure': 'Occurrence of urinary incontinence', 'timeFrame': '6 months after PAE', 'description': 'Assessment of ICS-SF questionnaire'}, {'measure': 'Occurrence of urinary incontinence', 'timeFrame': '12 months after PAE', 'description': 'Assessment of ICS-SF questionnaire'}, {'measure': 'Changes of free urinary flow rate', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Measurement of urinary stream (mL/s) by urinary flow rate measurement'}, {'measure': 'Changes of free urinary flow rate', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Measurement of urinary stream (mL/s) by urinary flow rate measurement'}, {'measure': 'Changes of free urinary flow rate', 'timeFrame': 'Baseline and 6 months', 'description': 'Measurement of urinary stream (mL/s) by urinary flow rate measurement'}, {'measure': 'Changes of free urinary flow rate', 'timeFrame': 'Baseline and 12 months', 'description': 'Measurement of urinary stream (mL/s) by urinary flow rate measurement'}, {'measure': 'Changes of post void residual urine', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Measurement of post void residual urine (mL) by transabdominal ultrasound'}, {'measure': 'Changes of post void residual urine', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Measurement of post void residual urine (mL) by transabdominal ultrasound'}, {'measure': 'Changes of post void residual urine', 'timeFrame': 'Baseline and 6 months', 'description': 'Measurement of post void residual urine (mL) by transabdominal ultrasound'}, {'measure': 'Changes of post void residual urine', 'timeFrame': 'Baseline and 12 months', 'description': 'Measurement of post void residual urine (mL) by transabdominal ultrasound'}, {'measure': 'Rate of local reinterventions', 'timeFrame': 'During 1 year study period', 'description': 'Assessment of number and type of reinterventions for prostate and bladder problems'}, {'measure': 'Intraoperative Adverse Events', 'timeFrame': 'While PAE is performed (intra-operatively)', 'description': 'Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE'}, {'measure': 'Adverse Events', 'timeFrame': '6 weeks after PAE', 'description': 'Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE'}, {'measure': 'Adverse Events', 'timeFrame': '12 weeks after PAE', 'description': 'Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE'}, {'measure': 'Adverse Events', 'timeFrame': '6 months after PAE', 'description': 'Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE'}, {'measure': 'Adverse Events', 'timeFrame': '12 months after PAE', 'description': 'Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE'}, {'measure': 'Feasibility of PAE', 'timeFrame': 'While PAE is performed (intra-operatively)', 'description': 'Possibility of successful completion of PAE in the study cohort defined by compete stasis of blood flow in the prostate'}, {'measure': 'Estimation of tumor burden', 'timeFrame': 'Baseline and 24h after PAE', 'description': 'Changes of Prostate Specific Antigen'}, {'measure': 'Estimation of tumor burden', 'timeFrame': 'Baseline and 6 weeks after PAE', 'description': 'Changes of Prostate Specific Antigen'}, {'measure': 'Estimation of tumor burden', 'timeFrame': 'Baseline and 12 weeks after PAE', 'description': 'Changes of Prostate Specific Antigen'}, {'measure': 'Estimation of tumor burden', 'timeFrame': 'Baseline and 6 months after PAE', 'description': 'Changes of Prostate Specific Antigen'}, {'measure': 'Estimation of tumor burden', 'timeFrame': 'Baseline and 12 months after PAE', 'description': 'Changes of Prostate Specific Antigen'}, {'measure': 'Estimation of tumor volume', 'timeFrame': 'Baseline and 12 weeks after PAE', 'description': 'Change of tumor volume calculated by magnetic resonance imaging'}, {'measure': 'Prostate volume', 'timeFrame': 'Baseline and 12 weeks after PAE', 'description': 'Change of prostate volume calculated by magnetic resonance imaging'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'prostate', 'embolization', 'minimally invasive', 'cytoreductive therapy'], 'conditions': ['Prostate Cancer', 'Bladder Outlet Obstruction']}, 'referencesModule': {'references': [{'pmid': '38416176', 'type': 'DERIVED', 'citation': 'Burkhardt O, Abt D, Hechelhammer L, Kim O, Omlin A, Schmid HP, Engeler D, Zumstein V, Mullhaupt G. Prostatic Artery Embolization in Patients with Advanced Prostate Cancer: A Prospective Single Center Pilot Study. Cardiovasc Intervent Radiol. 2024 Jun;47(6):771-782. doi: 10.1007/s00270-024-03679-z. Epub 2024 Feb 28.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot study assessing efficacy and safety in patients with advanced prostate cancer.', 'detailedDescription': 'PAE has been shown to be safe and effective in the treatment of prostatic bleeding and lower urinary tract symptoms arising from bladder outlet obstruction.\n\nAdvanced (defined as locally advanced, metastatic or both in this study) PCA is frequently associated with both of these conditions. The currently most frequently performed palliative surgical treatment is TURP. Though performed endoscopically, TURP is associated with significant side effects in this setting. PAE has been shown to have a superior side-effect profile in the treatment of bladder outlet obstruction compared to TURP.\n\nIn addition, there is growing evidence that patients with advanced PCA might benefit from cytoreductive therapy (e.g. radical prostatectomy or external beam radiation therapy). However, recent methods of cytoreductive treatment of PCA hold the risk of being highly invasive and are associated with severe side effects. PAE might represent a minimally invasive alternative in this setting.\n\nTherefore, efficacy and safety of PAE in patients with advanced prostate cancer is assessed in this pilot-study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Advanced PCA (i.e., locally advanced, metastatic, combination of both. This includes T3-4, any T in case of N1 and any T in case of M1a/b/c)\n* PAE is indicated for the treatment of Lower urinary tract symptoms like bladder outlet obstruction or recurrent prostatic bleeding.\n* IPSS at baseline ≥ 8\n* Witten informed consent\n\nExclusion Criteria:\n\n* Curative treatment of PCA intended\n* Contraindications for MRI\n* Renal impairment (GFR \\< 30ml/min)\n* Allergy to i.v. contrast medium\n* Vascular conditions that seem to make successful PAE impossible (e.g. severe atherosclerosis, severe tortuosity in the aortic bifurcation or internal iliac vessels)\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.\n* Drug-treatments for advanced prostate cancer (e.g., hormonal therapy or chemotherapy) established within 30 days prior to PAE.'}, 'identificationModule': {'nctId': 'NCT03457805', 'briefTitle': 'Prostatic Artery Embolization in Advanced Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cantonal Hospital of St. Gallen'}, 'officialTitle': 'Prostatic Artery Embolization (PAE) in Patients With Advanced Prostate Cancer: A Pilot Study.', 'orgStudyIdInfo': {'id': 'CTU17/028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Prostatic Artery Embolization (PAE)', 'description': 'PAE performed under local anesthesia using officially approved microspheres.', 'interventionNames': ['Device: Prostatic Artery Embolization']}], 'interventions': [{'name': 'Prostatic Artery Embolization', 'type': 'DEVICE', 'description': 'PAE is performed under local anesthesia using commercially available and approved microspheres (study is not limited to a specific manufacturer or product).', 'armGroupLabels': ['Prostatic Artery Embolization (PAE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9007', 'city': 'Sankt Gallen', 'state': 'Canton of St. Gallen', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Dominik Abt, MD', 'role': 'CONTACT', 'email': 'dominik.abt@kssg.ch', 'phone': '+41714941416'}, {'name': 'Gautier Müllhaupt, MD', 'role': 'CONTACT', 'email': 'Gautier.muellhaupt@kssg.ch', 'phone': '+41714941416'}], 'facility': 'Cantonal Hospital St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}], 'centralContacts': [{'name': 'Dominik Abt, MD', 'role': 'CONTACT', 'email': 'dominik.abt@kssg.ch', 'phone': '+41714941418'}], 'overallOfficials': [{'name': 'Dominik Abt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Gallen Cantonal Hospital, Dept. of Urology, Rorschacherstrasse 95, 9007 St. Gallen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Decision will be made individually up on request and based on approval by our local ethics committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dominik Abt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Dominik Abt', 'investigatorAffiliation': 'Cantonal Hospital of St. Gallen'}}}}