Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-02 @ 5:25 PM
Study NCT ID:
NCT06482658
Status:
COMPLETED
Last Update Posted:
2025-04-08
First Post:
2024-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Transrectal Perilesional Biopsy in Diagnosis of 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 380}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-05', 'studyFirstSubmitDate': '2024-06-25', 'studyFirstSubmitQcDate': '2024-06-25', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The clinically significant prostate cancer (csPCa) detection rate for PB/RSB and TB+SB', 'timeFrame': 'One month after the biopsy procedure.', 'description': 'csPCa was defined as PCa with a grade group \\> 2 or GS ≥ 7. The reference standard was the pathological result.'}], 'secondaryOutcomes': [{'measure': 'The overall complication rate', 'timeFrame': 'One month after the biopsy procedure.', 'description': 'The complication (mainly including bleeding, infection, pain, and lower urinary tract symptoms) rate after the prostate biopsy (PB/RSB or TB+SB).'}, {'measure': 'The self-reported quality of life after the prostate biopsy', 'timeFrame': 'One month after the biopsy procedure.', 'description': 'The self-reported levels of pain and discomfort after the prostate biopsy was measured through visual analogue scale (VAS). The minimum and maximum values of VAS are 0 and 10. The higher VAS means the higher level of pain and discomfort.'}, {'measure': 'The operation time of prostate biopsy', 'timeFrame': 'During the prostate biopsy procedure.', 'description': 'The operation time of prostate biopsy was defined as the time from the beginning to the end of the prostate biopsy.'}, {'measure': 'The PCa detection rate', 'timeFrame': 'One month after the biopsy procedure.', 'description': 'The PCa detection rate for PB/RSB and combination of TB+SB.'}, {'measure': 'The clinically insignificant PCa detection rate', 'timeFrame': 'One month after the biopsy procedure.', 'description': 'The clinically insignificant PCa was defined as PCa with a grade group \\< 2 or GS \\< 7. The reference standard was the pathological result.'}, {'measure': 'The Gleason score (GS) of the biopsy sample', 'timeFrame': 'One month after the biopsy procedure.', 'description': 'The Gleason score (GS) was reported by senior uropathologists according to the Standards of Reporting for MRI Targeted Biopsy Studies (START) criteria and interpreted according to the recommendations of the International Society of Urological Pathology (ISUP) Grade Group. The minimum and maximum of GS are 3 and 5. The higher GS means the higher pathological grade.'}, {'measure': 'The Gleason score (GS) of radical prostatectomy (RP) specimens', 'timeFrame': 'One month after the biopsy procedure.', 'description': 'For the RP specimens, the Gleason score (GS) was reported by senior uropathologists according to the Standards of Reporting for MRI Targeted Biopsy Studies (START) criteria and interpreted according to the recommendations of the International Society of Urological Pathology (ISUP) Grade Group. The minimum and maximum of GS are 3 and 5. The higher GS means the higher pathological grade.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate cancer', 'Randomized controlled trial', 'Transrectal perilesional biopsy', 'Transrectal regional systematic biopsy'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '41270377', 'type': 'DERIVED', 'citation': 'Deng R, Li D, Wu J, Tian S, Shen Q, Hu S, Shang M, Qiu J, Shang J, Zhou J, Cai L, Liu Y, Gong K. Comprehensive Evaluation of Targeted and Perilesional Biopsy in Biopsy-Naive Patients With Prostate Positive Magnetic Resonance Imaging: PERI-PRO Noninferiority Randomized Controlled Trial. J Urol. 2025 Dec 22:101097JU0000000000004863. doi: 10.1097/JU.0000000000004863. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': "The goal of this single-center randomized controlled trial (RCT) is to evaluate the efficacy and safety of different transrectal prostate biopsy schemes, including transrectal perilesional/regional systematic biopsy (PB/RSB) and combination of transrectal systematic biopsy and targeted biopsy (TB+SB).\n\nThe main questions it aims to answer are:\n\nDoes transrectal PB/RSB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB/RSB in improving the safety of transrectal prostate biopsy? Researchers will compare the cancer detection rates of transrectal PB/RSB and combination of TB+SB to explore the efficacy of different transrectal prostate biopsy schemes. They will evaluate the safety profile of different transrectal prostate biopsy schemes through the complication rates and postoperative quality of life.\n\nParticipants will:\n\nReceive transrectal PB/RSB or TB+SB.", 'detailedDescription': "Currently, combination of systematic biopsy and targeted biopsy (TB+SB) has been recommended for the diagnosis of patients with suspicious lesion found on multiparametric magnetic resonance imaging (mpMRI). Although the combined biopsy approach could effectively detect clinically significant prostate cancer (csPCa), the increased number of biopsy cores would increase the risk of complications and decrease the postoperative quality of life. In recent years, urological and radiologic thinking has changed after realizing that systemic biopsies may be omitted when the chance of missing a clinically significant lesion is low, or when a systemic biopsy has already been done beforehand. More and more radiologists and urologists focused on the issue of optimization of prostate biopsy schemes. Previous studies found that the majority of csPCa were found within a band of 10-mm radius outside MRI lesions (the penumbra). Based on the penumbra theory, the perilesional/regional systematic biopsy (PB/RSB) has gradually received urologists' attention. Some studies demonstrated that the prostate cancer (PCa) detection rate was not inferior to the combined biopsy with the benefits of using fewer biopsy cores. However, the safety profile warrants further evaluation, especially for transrectal prostate biopsy, and there is still a lack of high-quality, prospective evidence for the transrectal PB/RSB schemes. Thus, this single-center randomized controlled trial (RCT) aims to evaluate the efficacy and safety of transrectal PB/RSB schemes and the routine transrectal TB+SB schemes, provide high-quality evidence for the optimization of prostate biopsy schemes.\n\nThe main questions it aims to answer are:\n\nDoes transrectal PB/RSB promote the accurate diagnosis of csPCa? What is the value of PB/RSB in improving the safety of transrectal prostate biopsy? This prospective, multi-institution RCT compared the csPCa detection rates of transrectal PB/RSB and combination of transrectal TB+SB. Participants were prospectively enrolled at Peking University First Hospital (Beijing, China) from July 2024 to June 2025. Participants were randomly allocated to PB/RSB group and TB+SB group.\n\nResearchers will compare the cancer detection rates of transrectal PB/RSB and combination of transrectal TB+SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the safety profile of different transrectal prostate biopsy schemes through the complication rates and postoperative quality of life.\n\nParticipants will:\n\nReceive transrectal PB/RSB or TB+SB."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The age of the patient is between 45 and 85.\n* No previous biopsy,\n* Patients with single suspicious lesion, complete multiparametric magnetic resonance imaging (mpMRI) data, qualified image quality control, suspicious lesions, and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of ≥ 4.\n* Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) \\>10ng/mL, tPSA 4-10ng/mL with free-to-total PSA ratio (f/tPSA) \\<0.16 or PSA density (PSAD) \\>0.15.\n* The prostate biopsy pathological results were complete. The time interval between prostate biopsy and prostate mpMRI examination should not exceed one month.\n* Patients with complete clinical information.\n\nExclusion Criteria:\n\n* The mpMRI data was unqualified or incomplete.\n* Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate mpMRI examination or prostate biopsy.\n* Patients with previous biopsy.\n* Patients with PI-RADS V2.1 of \\< 4.\n* Patients were not in accordance with the indication of prostate biopsy.\n* The patient could not cooperate to complete the prostate biopsy.\n* The patients or their family members refused to participate in this study.\n* Patients with incomplete clinical information.'}, 'identificationModule': {'nctId': 'NCT06482658', 'briefTitle': 'Evaluation of Transrectal Perilesional Biopsy in Diagnosis of Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'Efficacy and Safety Evaluation of Transrectal Perilesional/Regional Systematic Biopsy in Diagnosis of Prostate Cancer: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PB-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transrectal perilesional/regional systematic biopsy (PB/RSB) group', 'description': 'For each predefined mpMRI suspicious lesion, urologists obtained nine cores at 5-mm intervals within and around the region of interest (penumbra) through transrectal prostate biopsy. The location of these nine cores depended on the shape and location of the suspicious lesion.', 'interventionNames': ['Procedure: Transrectal perilesional/regional systematic biopsy (PB/RSB)']}, {'type': 'EXPERIMENTAL', 'label': 'Combination of transrectal systematic biopsy and targeted biopsy (TB+SB) group', 'description': 'For patients in the TB+SB group, three to five transrectal targeted biopsies from the lesion were performed within and around the predefined mpMRI suspicious lesion, followed by fore-zone 12-core transrectal prostate biopsy.', 'interventionNames': ['Procedure: Combination of transrectal systematic biopsy and targeted biopsy']}], 'interventions': [{'name': 'Transrectal perilesional/regional systematic biopsy (PB/RSB)', 'type': 'PROCEDURE', 'description': 'The biopsy procedure was conducted by a highly skilled and experienced urologist who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. Each patient was placed in the left lateral position. The ultrasound equipment used included a color Doppler ultrasound diagnostic instrument (Hitachi HiVision, Philips Epiq 7), transrectal probes, and corresponding puncture needle guns. Color Doppler examination was performed from the base to the apex. For each predefined mpMRI suspicious lesion, urologists obtained nine cores at 5-mm intervals within and around the region of interest (penumbra) through transrectal prostate biopsy. The location of these nine cores depended on the shape and location of the suspicious lesion.', 'armGroupLabels': ['Transrectal perilesional/regional systematic biopsy (PB/RSB) group']}, {'name': 'Combination of transrectal systematic biopsy and targeted biopsy', 'type': 'PROCEDURE', 'description': 'The biopsy procedure was conducted by a highly skilled and experienced urologist who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. Each patient was placed in the left lateral position. The ultrasound equipment used included a color Doppler ultrasound diagnostic instrument (Hitachi HiVision, Philips Epiq 7), transrectal probes, and corresponding puncture needle guns. Color Doppler examination was performed from the base to the apex. Three to five transrectal targeted biopsies from the lesion were performed within and around the predefined mpMRI suspicious lesion, followed by fore-zone 12-core transrectal prostate biopsy.', 'armGroupLabels': ['Combination of transrectal systematic biopsy and targeted biopsy (TB+SB) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yi LIU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University First Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate chief physician', 'investigatorFullName': 'LIU Yi', 'investigatorAffiliation': 'Peking University First Hospital'}}}}