Application of PET-MR- a diagnostic accuracy study of combined dwMRI and 18F-Choline PET-CT for baseline staging of prostate cancer validated by extended laparoscopic lymph node dissection.

Application of PET-MR- a diagnostic accuracy study of combined dwMRI and 18F-Choline PET-CT for baseline staging of prostate cancer validated by extended laparoscopic lymph node dissection. - PET-MR for prostate cancer staging

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39287

Enrollment

Registered

2011-05-26

Start date

2011-11-24

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

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-80 2. Written informed consent 3. Biopsy proven prostate cancer cT1-T3 Nx M0 4. A chance of more than 15% of having lymph node metastases

Exclusion criteria

Exclusion criteria: 1. Neo-adjuvant treatments for prostate cancer . 2. Severe claustrophobia 3. Any metal prosthesis or device

Design outcomes

Primary

Measure	Time frame
Findings of ELND will serve as the reference standard. Analysis of PET-MR and lymph node dissections will be performed both on a per-region and per-patient basis. Patient- and region-based sensitivity and specificity of PET-MR will be calculated. In addition, the complication rate of ELND will be determined after 3 months follow-up.	—

Secondary

Measure	Time frame
In addition, the complication rate of ELND will be determined after 3 months follow-up.	—

Countries

Netherlands

Outcome results