Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Urogenital Neoplasms

Prostatic Diseases

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator.

Standard tru cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000).

Trans Rectal Ultrasound guided Prostate Biopsy using the assigned needle. Approximately 12 biopsies per patient.

Standard Tru Cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000)

Andreas Forsvall

Adam Linder, Ass prof

Andreas Forsvall, MD

Patient-blinded randomized controlled trial evaluating length and quality of prostate biopsies taken by a novel biopsy needle.

Prostate biopsy is the golden standard for prostate cancer diagnosis. Transrectal prostate biopsy (TRUSbx) is the most widely used technique. The biopsy chamber of the Tru Cut needle is in general 19 mm. However, it is on average filled only with 13 mm of tissue. Biopsy length is strongly correlated with diagnostic accuracy of prostate cancer.

Additionally, TRUSbx has a high risk of infection due to bacteria being brought across the colon wall. The investigators have shown that a new needle design reduces this bacterial transfer in an ex vivo setting and a previous trial (NCT049091230) has shown non inferior biopsy length when compared to the standard Tru Cut needle. A further improvement of the needle has now been designed aiming to increase biopsy length and quality, with the possible potential to improve prostate cancer diagnosis. This is the first human pilot aiming to evaluate if biopsy length of the novel needle is superior to a standard Tru Cut biopsy needle in prostate biopsy.

60 patients eligible for prostate biopsy are randomized into 2 arms (30+30 patients) using either the novel needle and actuator device or standard Tru Cut needle and actuator device used in the clinic today. On average 12 biopsies are taken from each patient. Biopsy length (primary outcome) is evaluated by a pathologist who is blinded to device used.

Patient and pathologist are unaware of which needle/device is used. All biopsies are taken from behind the back of the patient enabling masking from the patient. To assess masking success, patients will be asked to guess which device was used after the procedure is complete.

Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle

Numeric rating Pain Scale rating from 0-10

Any complications related to the biopsy (example infection, bleeding)

The number of sections the biopsy specimen is made of

General quality of biopsy specimen on a scale from 0-3 (no biopsy, poor, good, excellent)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle	NCT04880681	Prostate Cancer...	Novel needle (1... Standard Tru Cu...	40 Years -	Region Skane
Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle	NCT04880681	Prostate Cancer...	Novel needle (1... Standard Tru Cu...	40 Years -	Region Skane

Spots Global Cancer Trial Database for novel needle (18 g, 25 cm with 19 mm sample notch) in a new actuator.