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Clinical Trials/DRKS00005263
DRKS00005263
Recruiting
未知

Diagnostic performance of Prostate HistoScanningTM (PHS) in men at risk of prostate cancer scheduled for an initial prostate biopsy. - PHSTT-01

Advanced Medical Diagnostics SAWaterloo Office Park Bât i bte 30 sites391 target enrollmentMarch 13, 2014
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ConditionsSubjects suspected to have PCa who are schedules for a first prostate biopsy.C61Malignant neoplasm of prostate

Overview

Phase
未知
Intervention
Not specified
Conditions
Subjects suspected to have PCa who are schedules for a first prostate biopsy.
Sponsor
Advanced Medical Diagnostics SAWaterloo Office Park Bât i bte 3
Enrollment
391
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 13, 2014
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
Male

Investigators

Sponsor
Advanced Medical Diagnostics SAWaterloo Office Park Bât i bte 3

Eligibility Criteria

Inclusion Criteria

  • •Men at risk of PCa scheduled for first biopsy with serum total PSA
  • •\= 20 ng/ml (\= 10 ng/mL if taking 5\-alpha reductase inhibitors) from maximally 3 months ago
  • •Signed informed consent

Exclusion Criteria

  • •Previous prostate biopsy
  • •Confirmed PCa
  • •PSA \> 20 ng/ml (or \> 10 ng/mL if taking 5\-alpha reductase inhibitors)
  • •Active urinary tract infection
  • •Presence/history of any confirmed cancer
  • •Recent prostatic surgery (past 6 months)
  • •History of pelvic radiotherapy

Outcomes

Primary Outcomes

Not specified

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