Status Approved
First Submitted Date
2021/02/17
Registered Date
2021/03/16
Last Updated Date
2021/02/17
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005999 |
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Unique Protocol ID | 2019-0610 |
Public/Brief Title | MR-target Biopsy vs. TRUS-biopsy in Men with Suspicious Prostate Cancer: A paired Cohort blinded Study |
Scientific Title | MR-target Biopsy vs. TRUS-biopsy in Men with Suspicious Prostate Cancer: A paired Cohort blinded Study |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | Yes |
Name of Registry / Registration Number | ClinicalTrials.gov-NCT04320147 |
Healthcare Benefit Approval Status | Submitted pending |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 2019-0610 |
Approval Date | 2020-03-24 |
Institutional Review Board Name | Asan Medical Center Institutional Review Board |
Institutional Review Board Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul |
Institutional Review Board Telephone | 02-3010-7166 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | In Gab Jeong |
Title | Prof |
Telephone | +82-2-3010-5892 |
Affiliation | Asan Medical Center |
Address | Department of Urology, Asan Medical Center, 388-1 Pungnap2-dong, Songpa-gu, Seoul 138-736, Korea |
Contact Person for Public Queries | |
Name | Bumjin Lim |
Title | MD |
Telephone | +82-2-3010-5892 |
Affiliation | Asan Medical Center |
Address | Department of Urology, Asan Medical Center, 388-1 Pungnap2-dong, Songpa-gu, Seoul 138-736, Korea |
Contact Person for Updating Information | |
Name | Bumjin Lim |
Title | MD |
Telephone | +82-2-3010-5892 |
Affiliation | Asan Medical Center |
Address | Department of Urology, Asan Medical Center, 388-1 Pungnap2-dong, Songpa-gu, Seoul 138-736, Korea |
4. Status
Study Site | Single | |
---|---|---|
Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2020-03-27 Actual | |
Target Number of Participant | 300 | |
Primary Completion Date | 2021-12-31 , Anticipated | |
Study Completion Date | 2021-12-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Asan Medical Center | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2020-03-27 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Asan Medical Center |
Organization Type | Medical Institute |
Project ID | 2019-0610 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Asan Medical Center |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | To compare MR-target vs. standard TRUS (transrectal ultrasound)-biopsy for the diagnosis of clinically significant prostate cancer. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Cohort |
Time Perspective | Prospective |
Target Number of Participant | 300 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label Patients who are suspected of prostate cancer and want to undergo MR-target biopsy |
Cohort/Group Description Patients who are suspected of prostate cancer and want to undergo MR-target biopsy Patients who are suspected of prostate cancer and want to undergo MR-target biopsy |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | •1. Men undergoing a first-time prostate biopsy to rule out cancer •2. Serum PSA ≥3ng/mL, ≤20ng/mL •3. Age≥50 years, ≤80 years •4. Clinical stage ≤T2c •5. Patients must be able to provide written informed consent. |
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Sampling Method | ■ McNemar Test Power Analysis Numeric Results for Two-Sided Test Difference Proportion Odds Power N P10 P01 (P10-P01) Discordant Ratio Alpha Beta 0.90076 215 0.150 0.050 0.100 0.200 3.000 0.05000 0.09924 0.90039 270 0.175 0.075 0.100 0.250 2.333 0.05000 0.09961 0.90007 325 0.200 0.100 0.100 0.300 2.000 0.05000 0.09993 |
Condition(s)/Problem(s) |
* (C00-D48)Neoplasms (C61)Malignant neoplasm of prostate Patients suspected of prostate cancer |
Rare Disease | No |
Inclusion Criteria |
Gender Male |
Age 50Year~80Year |
|
Description •1. Men undergoing a first-time prostate biopsy to rule out cancer •2. Serum PSA ≥3ng/mL, ≤20ng/mL •3. Age≥50 years, ≤80 years •4. Clinical stage ≤T2c •5. Patients must be able to provide written informed consent. |
|
Exclusion Criteria |
•1. Patients has any prior needle biopsy of the prostate •2. Patients has a prior history of prostate cancer •3. Patients has a prior history of pelvic radiation therapy or androgen deprivation therapy •4. Patients has a prior history of BPH operation •5. Patient with uncorrectable coagulopathies •6. Unable to tolerate a TRUS guided biopsy. •7. Patients had 5-alpha reductase inhibitor in the past six months. •8. The patient has had a urinary tract infection or acute prostatitis in the last three months. •9. Any contraindication to MRI (severe claustrophobia, pacemaker, MRI-incompatible prosthesis, eGFR ≤50mls/min) |
Healthy Volunteers |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | 1.Proportion of clinically significant prostate cancer (≥Gleason score 3+4) [ Time Frame: 2 week after the procedure ] |
|
Timepoint | visit 4 |
|
Secondary Outcome(s) 1 | ||
Outcome | 1.Proportion of clinically insignificant prostate cancer (Gleason score 6) [ Time Frame: 2 week after the procedure ] |
|
Timepoint | visit 4 |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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