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Prostate cancer: which patients need (repeated) prostate biopsies and how many biopsies do they need?

Prostate cancer: which patients need (repeated) prostate biopsies and how many biopsies do they need?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28233
Enrollment
400
Registered
2008-07-07
Start date
2004-10-22
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

Prostate Cancer

Interventions

All biopsies will be taken in the left lateral decubitus position. Group 1: 8 ultrasound-guided transrectal biopsies, laterally aimed in the peripheral zone: one from the apex, two from the middle a

Sponsors

AMC, department of Urology, Amsterdam, the Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 1,24 ng/ml 2. Age > 49 2,24 ng/ml 3. Age > 59 2,24 ng/ml 4. Age >69 and PSA > 3,24 ng/ml 5. Abnormal DRE 6. Abnormal TRUS

Exclusion criteria

Exclusion criteria: 1. Age < 18 2. Proven prostate cancer 3. Clinical prostatitis < 1 month ago 4. Acute urinary retention < 1 month ago 5. PSA altering medicine (finasteride, dutasteride) used in the last 6 months

Design outcomes

Secondary

MeasureTime frame
- How do the primary outcomes relate to patient characterisics such as age, PSA, PSA-ratio, complexed PSA, symptoms. - How many more complications occur in a 12 biopsy-protocol compared to an 8- biopsy protocol.

Primary

MeasureTime frame
- How many prostate cancers are found using a 12-biopsy protocol compared to an 8-biopsy protocol. - How many cancers are found in repeated biopsies after using a 12-biopsy protocol compared to an 8-biopsy protocol - What % of cancers is found in the transition zone only in repeated biopsies after using a 12-biopsy protocol compared to an 8-biopsy protocol

Contacts

Public ContactS.A. Zaaijer

Academic medical Center (AMC) Department of Urology P.O. Box 22660

S.A.Zaaijer@amc.uva.nl+31 (0)20 5666030

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)