Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-02-20 @ 10:57 PM
Study NCT ID:
NCT02375035
Status:
UNKNOWN
Last Update Posted:
2015-03-02
First Post:
2015-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer
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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-24', 'studyFirstSubmitDate': '2015-02-19', 'studyFirstSubmitQcDate': '2015-02-24', 'lastUpdatePostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score assessment of CAMPROBE biopsy procedure', 'timeFrame': '3 weeks', 'description': 'Measured using a 10 point visual pain score tool and a point based structured questionnaire'}, {'measure': 'Patient reported adverse events related to CAMPROBE biopsy', 'timeFrame': '3 weeks', 'description': 'Point based structured questionnaire assessment of adverse events after biopsy'}, {'measure': 'Patient perception and acceptance of CAMPROBE biopsy', 'timeFrame': '3 weeks', 'description': 'Point based structured questionnaire including willingness to recommend to a friend'}], 'secondaryOutcomes': [{'measure': 'Deterioration in urinary function after CAMPROBE biopsy', 'timeFrame': '3 weeks', 'description': 'Measurement of urinary function after the procedure using a structured questionnaire'}, {'measure': 'Deterioration in sexual function after CAMPROBE biopsy', 'timeFrame': '3 weeks', 'description': 'Measurement of urinary function after the procedure using a structured questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'Prostate Biopsy']}, 'descriptionModule': {'briefSummary': 'To evaluate the use of the CAMbridge PROstate Biopsy devicE (CAMPROBE) as a method of undertaking prostate biopsy as part of their clinical management.', 'detailedDescription': "To assess patient's experience and complications of the CAMPROBE and compare the results with known published outcomes from standard transrectal biopsies .\n\nTo use data from the pilot study to determine the feasibility of a randomised trial comparing CAMPROBE with the current standard method of prostate biopsies."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who have had a standard biopsy and now require a transrectal biopsy as part of their management', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fit and well enough to undergo a repeat prostate biopsy\n* Men who have previously had a transrectal ultrasound biopsy of the prostate and due to have a repeat biopsy as part of normal care\n* Men on active surveillance\n* Men on PSA monitoring\n\nExclusion Criteria:\n\n* Contraindication for a repeat prostate biopsy\n* Contraindication for a transperineal prostate biopsies\n* Previous perineal or anal surgery\n* MRI suggesting anterior lesion or extra capsular disease\n* MRI suggesting lesion that needs fusion image targeting\n* Unable to lie down and with legs in a stirrup for at least 45 minutes'}, 'identificationModule': {'nctId': 'NCT02375035', 'acronym': 'CAMPROBE', 'briefTitle': 'Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer', 'orgStudyIdInfo': {'id': 'AO93224'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CAMPROBE', 'type': 'DEVICE', 'description': "To assess patient's experience and complications of the CAMPROBE biopsy needle and compare the results with known published outcomes from standard transrectal biopsies"}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0QQ', 'city': 'Cambridge', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Stephen Kelleher', 'role': 'CONTACT', 'email': 'r&denquiries@addenbrookes.nhs.uk', 'phone': '+44 1223 217418'}], 'facility': 'Cambridge University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'centralContacts': [{'name': 'Vincent Gnanapragasam', 'role': 'CONTACT', 'email': 'vjg29@cam.ac.uk', 'phone': '+44 1223 348363'}, {'name': 'Anne George', 'role': 'CONTACT', 'email': 'anne.george@addenbrookes.nhs.uk', 'phone': '+44 1223 348440'}], 'overallOfficials': [{'name': 'Vincent Gnanapragasam', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cambridge'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in Uro-oncology and Consultant Urological Surgeon', 'investigatorFullName': 'Vincent Gnanapragasam', 'investigatorAffiliation': 'Cambridge University Hospitals NHS Foundation Trust'}}}}