Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402552
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-05-03
Brief Title:
Comparing Bp-MRI and Mp-MRI for Prostate Cancer Screening Accuracy
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
A Randomized Controlled Trial Comparing Bp-MRI and Mp-MRI on the Screening Accuracy for Clinically Significant Prostate Cancer Before MRI-fusion Targeted Biopsy
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
31 Study Objectives 311 Primary objective The investigators aim to address these questions for Taiwan males suspicious of csPCA with PSA range of 4-20 ngml by conducting a RCT trial
32 Study endpoints 321 Primary endpoint The proportion of men with clinically significant Prostate cancercsPCa defined as a diagnosis of ISUP International Society of Urogenital Pathology Grade group 2 prostate cancer in at least one biopsy core
322 Secondary endpoints
1 The proportion of men with a diagnosis of any PCa
2 The proportion of men with a diagnosis of clinically insignificant PCa defined as ISUP grade group 1 PCa ISUP 1 PCa
3 The proportion of men with a diagnosis of csPCa
4 Only in targeted biopsy
5 Only in systematic biopsy
6 The proportion of csPCa of all suspicious lesions from bp-MRI and mp-MRI
32 Study endpoints 321 Primary endpoint The proportion of men with clinically significant Prostate cancercsPCa defined as a diagnosis of ISUP International Society of Urogenital Pathology Grade group 2 prostate cancer in at least one biopsy core
322 Secondary endpoints
1 The proportion of men with a diagnosis of any PCa
2 The proportion of men with a diagnosis of clinically insignificant PCa defined as ISUP grade group 1 PCa ISUP 1 PCa
3 The proportion of men with a diagnosis of csPCa
4 Only in targeted biopsy
5 Only in systematic biopsy
6 The proportion of csPCa of all suspicious lesions from bp-MRI and mp-MRI
Detailed Description:
Study intervention MRI prostate Bi-parametric and multi-parametric MRI prostates can be performed using a 30 Tesla scanner with a pelvic phased array coil with or without contrast MRI findings will be reported according to PI-RADS Prostate Imaging-Reporting and Data Systems v21 recommendations MRI will be reported by radiologists with experience in MRI prostate reporting PI-RADS scores 3-5 will be regarded as suspicious and targeted plus systematic biopsy will be performed
Prostate biopsy In patients with suspicious lesion found on MRI identified as PI-RADS score 3-5 lesions on bp-MRI or mp-MRI biopsies will be done via trans-perineal approach under general anesthesia with 3 cores of targeted biopsy from each lesion alone with 3 cores of systemic biopsy from right and left lobes respectively
In those without identified suspicious lesions on MRI a standard 12-core systematic biopsy will be performed via trans-rectal approach under local anesthesia
All biopsies will be performed by Urologists experienced in both targeted and systemic prostate biopsy Targeted biopsies will be done by software-assisted MRI-USG fusion registration Peri-biopsy antibiotics are given according to our clinical guidelines
Post-biopsy management Patients will be discharged after prostate biopsy when they can pass urine without significant gross hematuria and clinically stable They will be followed up in the clinic within 10 days after a biopsy to review pathology results and complications All biopsies will be assessed by experienced Urogenital pathologists and reported according to the International Society of Urological Pathology ISUP consensus The study period ends after the first clinic follow-up
In our medical research the investigators prioritize protecting participant privacy and confidentiality The investigators use unique research codes to anonymize personal details like names and IDs The principal investigator keeps consultation results and diagnoses confidential even in published research Participants consent to have their records reviewed by authorized parties for legal and ethical compliance with a promise of maintaining their anonymity For safety the investigators may inform participants other doctors about their trial involvement to manage treatment interactions Overall these steps ensure participant privacy and safety throughout the research
Prostate biopsy In patients with suspicious lesion found on MRI identified as PI-RADS score 3-5 lesions on bp-MRI or mp-MRI biopsies will be done via trans-perineal approach under general anesthesia with 3 cores of targeted biopsy from each lesion alone with 3 cores of systemic biopsy from right and left lobes respectively
In those without identified suspicious lesions on MRI a standard 12-core systematic biopsy will be performed via trans-rectal approach under local anesthesia
All biopsies will be performed by Urologists experienced in both targeted and systemic prostate biopsy Targeted biopsies will be done by software-assisted MRI-USG fusion registration Peri-biopsy antibiotics are given according to our clinical guidelines
Post-biopsy management Patients will be discharged after prostate biopsy when they can pass urine without significant gross hematuria and clinically stable They will be followed up in the clinic within 10 days after a biopsy to review pathology results and complications All biopsies will be assessed by experienced Urogenital pathologists and reported according to the International Society of Urological Pathology ISUP consensus The study period ends after the first clinic follow-up
In our medical research the investigators prioritize protecting participant privacy and confidentiality The investigators use unique research codes to anonymize personal details like names and IDs The principal investigator keeps consultation results and diagnoses confidential even in published research Participants consent to have their records reviewed by authorized parties for legal and ethical compliance with a promise of maintaining their anonymity For safety the investigators may inform participants other doctors about their trial involvement to manage treatment interactions Overall these steps ensure participant privacy and safety throughout the research
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None