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Trial Lecture – time and place
See Trial Lecture.
Adjudication committee
- First opponent: Associate Professor Sigrid Carlsson, Memorial Sloan Kettering Cancer Center / DFKZ German Cancer Research Center, USA / Germany
- Second opponent: Professor II Gunnar Skov Simonsen, UiT The Arctic University of Norway,
- Third member and chair of the evaluation committee: Professor Mette Kalager, University of Oslo
Chair of the Defence
Professor emeritus Jarl Åsbjørn Jakobsen, University of Oslo
Principal Supervisor
Associate professor Eduard Baco, Oslo University Hospital
Summary
The NORAPP study - transperineal prostate biopsies without antibiotic prophylaxis What was the study about? Diagnosing prostate cancer requires prostate tissue biopsies. Traditionally samples have been taken by passing a needle through the rectum into the prostate. Despite the use of prophylactic antibiotics, the method has been associated with infections and sepsis.
Access through the perineum is an alternative. With this approach the rectal flora is avoided. The method has been performed with prophylactic antibiotics, in an operating theater under general anesthesia, and with limited knowledge regarding cancer detection rates.
The aim of the randomized controlled trial was to investigate whether prophylactic antibiotics can be omitted when biopsies are taken through the perineum, whether the procedure can be performed in an outpatient setting under local anesthesia, and if the approach provides good cancer detection.
Methods and results 555 patients were included in Oslo and Berlin. They were randomly assigned to a group that received prophylactic antibiotics and a group that did not. All biopsies were performed in an outpatient setting under local anesthesia.
No patients developed sepsis; four patients were treated for a mild infection with oral antibiotics. 137 patients needed to recieve prophylactic antibiotics in order to avoid one infection.
Pain levels were low throughout the procedure, averaging 1 out of 10 during the sampling itself. No procedures were aborted due to pain and no serious or lasting adverse events occured. No patients were admitted to hospital for any reason.
The study demonstrated good cancer detection. The overall cancer detection rate was 65% and 91% when there was a high suspicion of cancer.
What does this mean? The NORAPP study showed that prophylactic antibiotics can be omitted when performing prostate biopsies with a transperineal approach, that the procedure can be carried out in an outpatient setting under local anesthesia with limited discomfort and few adverse effects, and that it yields good cancer detection rates.
Additional information
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