Fusion target biopsy of the prostate using real-time ultrasound and MR images

Fusion target biopsy of the prostate using real-time ultrasound and MR images - FUTURE Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44521

Enrollment

674

Registered

2014-11-19

Start date

2014-12-01

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Prostate cancer

Interventions

Study intervention: MRI/TRUS fusion target perineal prostate biopsy Comparator interventions: Cognitive TRUS target prostate biopsy In-bore MRI target transrectal prostate biopsy

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -At least 18 years old and mentally competent -At least one negative TRUS guided biopsy session (no cancer diagnosis) within the last 4 years -A PSA value of >4.0 ng/ml and/or suspicious rectal examination

Exclusion criteria

Exclusion criteria: -Prior diagnosed or treated prostate cancer -Proven urinary tract infection -Unwillingness/inability to undergo MRI imaging -Unwillingness/inability to undergo target biopsy session -Unwillingness to undergo biochemical follow-up -Prior target biopsy procedures of the prostate based on MR imaging

Design outcomes

Primary

Measure	Time frame
Biopsy cores containing prostate cancer; Gleason score in biopsy cores; number of systematic and target biopsy cores taken.	—

Secondary

Measure	Time frame
Occurrence of adverse effects; treatment of adverse effect; duration of biopsy procedure; number of mpMRI suspicious lesions; PI-RADS score of lesions; imaging staging; pathological staging (if prostatectomy follows); imaging modalities/applications used; Baseline characteristics (PSA value; prostate volume; age of subjects; number of previous negative biopsy sessions) Questionnaire scores (EQ5D5L/IPSS/SHIM)	—

Measure

Time frame

Occurrence of adverse effects; treatment of adverse effect; duration of biopsy procedure; number of mpMRI suspicious lesions; PI-RADS score of lesions; imaging staging; pathological staging (if prostatectomy follows); imaging modalities/applications used; Baseline characteristics (PSA value; prostate volume; age of subjects; number of previous negative biopsy sessions) Questionnaire scores (EQ5D5L/IPSS/SHIM)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)