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A Prospective Randomized Trial of Prostate Biopsy Protocols Comparing the Vienna Nomogram and a Standard 10-core Biopsy Scheme


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Prostate Cancer

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Trial Information

A Prospective Randomized Trial of Prostate Biopsy Protocols Comparing the Vienna Nomogram and a Standard 10-core Biopsy Scheme


Trans rectal ultrasound (TRUS) guided prostate biopsy remains the standard for prostate
cancer diagnosis. However, the standard protocols miss 15 to 30% of cancers, leading to a
variable number of repeat biopsies.

In 2005 the Vienna nomogram was introduced, defining the number of cores to be obtained in a
prostate biopsy in relation to age and prostate volume in patients with a serum PSA level of
2-10 ng/mL.

The objective of the study is to determine if the Vienna nomogram increases the detection
rate of trans rectal ultrasound guided prostate biopsies, compared to a 10-core biopsy.

This prospective randomized study enrolled men eligible for a prostate biopsy were
randomized to a Vienna nomogram protocol or a 10-core protocol. They were further stratified
according to age (≤65; >65 and ≤70; >70 years) and prostate volume (≤30; >30 and ≤50; >50
and ≤70; >70 cc).

A subgroup analysis for patients with serum PSA values between 2 and 10 ng/mL was performed.


Inclusion Criteria:



- PSA elevation

- Abnormal digital rectal examination

- Abnormal findings on prostate imaging

Exclusion Criteria:

- Active urinary tract infection

- Documented previous pathological prostatitis

- History of urinary retention

- Recent lower urinary tract surgery

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Prostate cancer detection rate

Outcome Time Frame:

Up to four weeks after intervention

Safety Issue:

No

Principal Investigator

Tito P Leitão, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital de Santa Maria

Authority:

Portugal: Comissão de Ética para a Saúde do CHLN/FML

Study ID:

BPTRVienna

NCT ID:

NCT01752140

Start Date:

January 2009

Completion Date:

July 2010

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • Prostate biopsy
  • Vienna nomogram
  • Prostatic Neoplasms

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