Exploratory clinical trial of PROMISE-I for the evaluation of cancer segmentation in the prostate fusion biopsy patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006421

Enrollment

100

Registered

2021-08-04

Start date

2021-10-06

Completion date

Unknown

Last updated

2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Prostate fusion biopsy In patients with suspected prostate cancer due to elevated PSA, etc., finding the suspicious part on the prostate MRI, load the MRI image into the ultrasound ma

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: (1) patients who consented this study (2) Referred for the fusion biopsy of the prostate (3) Men aged over 30

Exclusion criteria

Exclusion criteria: (1) Patients who are contraindicated for the biopsy of the prostate i. Patients with bleeding tendency including recent use of acetylsalicylic acid ii. Patients allergic to lidocaine iii. Patients who cannot tolerate the pain of biopsy due to anal surgery, etc. (2) Patients who did not undergo prostate MRI before the biopsy (3) Patients whose fusion images are not technically produced (4) Patients who did not undertake prophylactic antibiotics (5) Patients who did not undertake prebiopsy enema

Design outcomes

Primary

Measure	Time frame
Cancer detection rate of clinically significant cancer by patient	—

Secondary

Measure	Time frame
Cancer detection rate of clinically significant cancer by core	—

Countries

Korea, Republic of

Contacts

Public ContactSung Il Hwang

Seoul National University Bundang Hospital

hwangsi49@gmail.com+82-31-787-7621

Outcome results