Value of multiparametric MR and MRI-guided biopsies of the prostate in men with an elevated PSA

Value of multiparametric MR and MRI-guided biopsies of the prostate in men with an elevated PSA - Value of MRI in diagnosing prostate cancer

Status

Recruiting

Phases

Phase 3

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39439

Enrollment

620

Registered

2013-09-17

Start date

2015-01-13

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

prostate cancer prostatic carcinoma

Interventions

All men will undergo an MRI-scan. If suspicious lesions are present, also MRI-guided biopsies will be taken. If no abnormalities are seen, no MR-guided biopsies will be performed. Afterwards, all me

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Men, 50-75 years, PSA > 3 ng/ml

Exclusion criteria

Exclusion criteria: Use of 5-alfareductase inhibitors Proven prostate cancer

Design outcomes

Primary

Measure	Time frame
Primary endpoint: clinical insignificant versus significant cancers detected.	—

Secondary

Measure	Time frame
Secondary endpoints: health-related quality of life, accuracy of MR-guided biopsies, cost effectiveness	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)