Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2026-01-02 @ 7:52 AM
Study NCT ID:
NCT01875393
Status:
COMPLETED
Last Update Posted:
2016-04-19
First Post:
2013-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C503696', 'term': 'padeliporfin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-17', 'studyFirstSubmitDate': '2013-06-07', 'studyFirstSubmitQcDate': '2013-06-07', 'lastUpdatePostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To confirm that a significant proportion of patients will be prostate cancer free on the biopsy.', 'timeFrame': 'Month 12', 'description': 'Number of patients with a negative biopsy.'}], 'secondaryOutcomes': [{'measure': 'Changes in urinary and erectile functions and their potential impact on quality of life using International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF) and the General quality of life (EQ5D) questionnaires.', 'timeFrame': 'Screening, 1, 3, 6 and 12 months after completing treatment', 'description': "Patients' reported outcome measures (PROMs) impairment: urinary symptoms using IPSS and erectile functions using IIEF. Quality of life using EQ5D will also be described"}, {'measure': 'The rate of adverse events.', 'timeFrame': 'Screening-Month 12', 'description': 'Adverse event reporting.'}, {'measure': 'The overall cancer burden in the prostate determined by biopsy as compared to baseline.', 'timeFrame': 'Month 12', 'description': 'Total length of cancer present in all cores taken in any given biopsy session'}, {'measure': 'The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death', 'timeFrame': 'Screening-Month 12', 'description': 'Severe prostate cancer related events: cancer extension to T3, metastasis or prostate cancer-related death.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostatic Disease', 'Genital Neoplasm,male', 'Urogenital neoplasm', 'Genital disease,male', 'Male urogenital disease', 'Neoplasms', 'Neoplasms by site', 'Prostatic neoplasm', 'Carcinoma'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '25712310', 'type': 'DERIVED', 'citation': 'Azzouzi AR, Barret E, Bennet J, Moore C, Taneja S, Muir G, Villers A, Coleman J, Allen C, Scherz A, Emberton M. TOOKAD(R) Soluble focal therapy: pooled analysis of three phase II studies assessing the minimally invasive ablation of localized prostate cancer. World J Urol. 2015 Jul;33(7):945-53. doi: 10.1007/s00345-015-1505-8. Epub 2015 Feb 25.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to confirm the Efficacy,the Safety and the Quality of Life after TOOKAD® Soluble VTP in localized prostate cancer patients.', 'detailedDescription': 'The study is designed as a multicenter, single-arm, open label, 12 months follow-up clinical trial. Men with localized prostate cancer will be treated with TOOKAD® Soluble VTP under general anesthesia.\n\nPatients will be followed-up for 12 months with patient questionnaires on QoL, erectile and urinary functions, clinical evaluation with study visits at 1, 3, 6 and 12 months , Prostate Specific Antigen(PSA) testing at 3, 6 and 12 months. In addition, they will have biopsy at 6 months (± 2) and 12 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically proven localized prostate carcinoma diagnosed using prostate biopsy showing:\n\n * Gleason 3+3 prostate\n * Gleason 3+4 prostate adenocarcinoma is acceptable provided it is not present in more than 2 cores and no more than 50% cancer in any core.\n* Clinical stage up to cT2a - N0/Nx - M0/Mx.\n* Serum prostate-specific antigen (PSA) ˂ 20ng/ml\n* Prostate volume ≥ 25 cc and ≤ 70 cc.\n* Male subjects aged 18 years or older.\n* Signed Informed Consent Form by the patient.\n\nExclusion Criteria:\n\n* Unwillingness to accept the treatment.\n* Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy)or chemotherapy.\n* Any surgical intervention for benign prostatic hypertrophy.\n* Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure.\n* Life expectancy less than 10 years.\n* Participation in another clinical study involving an investigational product within 1 month before study entry.\n* Subject unable to understand the patient's informed consent document, to give consent voluntarily or to complete the study tasks, especially unable to understand and fulfill the health-related QoL questionnaire.\n* Subject in custody and or in residence in a nursing home or rehabilitation facility.\n* Any condition or history of active rectal inflammatory bowel disease or other factors which may increase the risk of fistula formation;\n* Any hormonal manipulation (excluding 5-alpha-reductase inhibitors) that alters androgen production or use of androgen supplements within the previous 6 months;\n* Any history of urethral stricture disease;\n* Any history of acute urinary retention within 6 months of study entry"}, 'identificationModule': {'nctId': 'NCT01875393', 'acronym': 'PCM304', 'briefTitle': 'Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Steba Biotech S.A.'}, 'officialTitle': 'Study of the Efficacy,Safety and Quality of Life After TOOKAD® Soluble Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Localized Prostate Cancer', 'orgStudyIdInfo': {'id': 'CLIN1201 PCM304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TOOKAD® Soluble', 'description': 'TOOKAD® Soluble, lyophilized formulation,given at a dose of 4 mg/kg.', 'interventionNames': ['Drug: TOOKAD® Soluble']}], 'interventions': [{'name': 'TOOKAD® Soluble', 'type': 'DRUG', 'otherNames': ['WST11'], 'description': 'The VTP procedure will consist of a single, 10 minute infusion of 4mg/kg TOOKAD® Soluble. The drug will be activated by laser light at 753nm, with a fixed energy of 200Joules/cm, and a fixed power of 150mWatts/cm, delivered through transperineal interstitial optical fibers. The needles are positioned in the prostate under ultra sound image guidance.', 'armGroupLabels': ['TOOKAD® Soluble']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13278', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Hospital General Tlahuac', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Panama City', 'country': 'Panama', 'facility': 'Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'city': 'San Martín de Porres', 'country': 'Peru', 'facility': 'Hospital Nacional Cayetano Heredia', 'geoPoint': {'lat': -8.39936, 'lon': -74.56901}}], 'overallOfficials': [{'name': 'Jose Arturo Rodriguez Rivera, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital General Tlahuac'}, {'name': 'Mary Lol Ve Mendoza Medina, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital General Tlahuac'}, {'name': 'Luis Zegarra Montes, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Nacional Cayetano Heredia'}, {'name': 'Ramón Rodriguez, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The data are available in case report form for each patient'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steba Biotech S.A.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}