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Comparisson of HistoScannnig guided prostate biopsy with systematic prostate biopsy in the detection of prostate cancer.

A pilot study to compare HistoScanning guided prostate biopsy with systematic biopsy in the detection of prostate cancer.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28683
Enrollment
30
Registered
2010-05-27
Start date
2010-04-26
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Prostatic neoplasms, prostate biopsy, computer aided ultrasonography, Histoscanning. Prostaatkanker, prostaatbiopsie, computer ondersteunde echografie.

Interventions

There will be no intervention. Patients undergo systematic and guided biopsies (invasive measurement).

Sponsors

Erasmus Medical Center, Department of Urology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male patient aged ≥ 40 years; 2. Patient with a clinical suspicion of prostate cancer and scheduled for first bioptic procedure or patient who already received one systematic biopsy procedure with negative results currently under follow-up procedure due to a persistent indication; 3. Provides written informed consent and is willing and able to comply with protocol requirements.

Exclusion criteria

Exclusion criteria: 1. A history of previous prostate surgery; 2. Clinically apparent prostatitis within one month of biopsy; 3. Active urinary tract infection; 4. Has received a bioptic procedure within 30 days before admission into this study; 5. Incapable of understanding the language in which the information for the patient is given.

Design outcomes

Primary

MeasureTime frame
Binary variable in terms of benign or malignant.

Secondary

MeasureTime frame
1. Gleason score; 2. Proportion of positive biopsy cores.

Contacts

Public ContactS. Heuvel, van den

ErasmusMC Room H-187 's Gravendijkwal 230

s.vandenheuvel.1@erasmusmc.nl+31 (0)10 703 2640

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)