Prostate Neoplasm Clinical Trial
Official title:
Evaluation of Feasibility, Complications And Functional Results Of Free-Hand Transperineal Image Fusion Targeted Biopsies Under Local Anesthesia: A Prospective Study
NCT number | NCT04376008 |
Other study ID # | IUNU-PC-104 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | June 1, 2022 |
This trial aims to prospectively assess the feasibility, complications and functional results of free-hand transperineal image fusion targeted biopsies under local anesthesia in a large group of patients.
Status | Completed |
Enrollment | 1050 |
Est. completion date | June 1, 2022 |
Est. primary completion date | May 1, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Men more than 18 years old with clinical suspicion of prostate cancer; - Serum PSA = 20 ng/ml within the previous 3 months; - Suspected stage = T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months; - No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis; - Able to provide written informed consent. Exclusion Criteria: - Prior prostate biopsy or prostate surgery; - Prior treatment for prostate cancer; - Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate = 50mls/min); - Contraindication to prostate biopsy. |
Country | Name | City | State |
---|---|---|---|
China | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biopsy unfinished rates | The proportion of patients who failed to complete the biopsy due to various reasons during the biopsy | 1 days | |
Primary | Pain score | Numerical pain scale score during biopsy, the minimum to maximum value is 0 to 10, and higher scores mean a worse outcome | 3 days peri-biopsy | |
Primary | Hospitalization rate due to biopsy | The proportion of subjects requiring hospitalization for various reasons within 7 days after puncture | 7 days post biopsy | |
Secondary | Detection rates of clinically significant PCa | Clinically significant prostate cancer is considered as: biopsy Gleason score =3+4 or maximum cancer core length =5 mm. | 30 days post biopsy | |
Secondary | Detection rates of PCa | Prostate cancer is considered as: biopsy Gleason score =3+3 | 30 days post biopsy | |
Secondary | Biopsy-related complication rates | 30 days post biopsy | ||
Secondary | Biopsy time | How much time is used during biopsy | 1 days | |
Secondary | Consistency rate with final pathology | Concordance rate between biopsy and final pathology | 30 days post biopsy | |
Secondary | international index of erectile function-5 (IIEF-5) score | pre- and post-procedural erectile function score, the minimum to maximum value is 0 to 25, and higher scores mean a better outcome | 30 days post biopsy | |
Secondary | International prostate symptom score (IPSS) | pre- and post-procedural urinary function score, the minimum to maximum value is 0 to 35, and higher scores mean a worse outcome | 30 days post biopsy |
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