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

Region Skane

Status: Enrolling

Conditions: Prostate Cancer (Diagnosis)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04880681

double needle

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligible for prostate biopsy
• Signed informed written consent

Exclusion criteria

• None (other than general contraindications for prostate biopsy or patient not willing to participate)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Novel needle

Experimental group

Description:

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

Treatment:

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

Standard Tru Cut needle

Active Comparator group

Description:

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).

Treatment:

Device: 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)