Prostate Cancer Clinical Trial
Official title:
MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer: A Paired Cohort Study
This paired cohort blinded trial aims to assess the detection rate of clinically significant
cancer of MRI-targeted biopsy compared to standard 12-core TRUS biopsy in men referred with
clinical suspicion of prostate cancer who have had no prior prostate biopsy. The
investigators hypothesize that additional MRI-targeted biopsy will detect more clinically
significant cancers than standard TRUS biopsy.
Main objective: To compare MR-target vs. standard 12-cores TRUS-biopsy for the diagnosis of
clinically significant prostate cancer.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | April 1, 2023 |
Est. primary completion date | April 1, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Asan Medical Center | Bumjin Lim, Choung-Soo Kim, Dalsan Yoo, Hanjong Ahn, Hyung Keun Park, Jeong Kon Kim, Jun Hyuk Hong, Kye Jin Park, Mi-Hyun Kim |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of clinically significant prostate cancer (=Gleason score 3+4) | 2 week after the procedure | ||
Secondary | Proportion of clinically insignificant prostate cancer (Gleason score 6) | 2 week after the procedure | ||
Secondary | Proportion of men in whom mpMRI score (PI-RADS) for suspicion of clinically significant cancer was 3, 4 or 5 | 2 week after the procedure | ||
Secondary | Correlation of prostate health index (Phi), phi density and MRI fusion Bx in predicting clinically significant prostate cancer | 2 week after the procedure | ||
Secondary | Cancer core length of the most involved biopsy core (maximum cancer core length, mm) | 2 week after the procedure | ||
Secondary | Proportion of men who go on to definitive local treatment or systemic treatment | 2 week after the procedure | ||
Secondary | Proportion of Gleason grade upgrading in men undergoing radical prostatectomy | 2 week after the surgery | ||
Secondary | Adverse events of post-biopsy (pain, infection, bleeding etc.) | 2 week after the procedure | ||
Secondary | Inter-observer variability among radiologists | 2 week after the procedure |
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