Prostate Cancer (Diagnosis)
Conditions
Keywords
Prostatic Neoplasms, Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site, Prostatic Diseases
Brief summary
Patient-blinded randomized controlled trial evaluating length and quality of prostate biopsies taken by a novel biopsy needle.
Detailed 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.
Interventions
DEVICENovel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator.
Trans Rectal Ultrasound guided Prostate Biopsy using the assigned needle. Approximately 12 biopsies per patient.
DEVICEStandard 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.
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prostate biopsy length (measured by pathologist) | within 21 days post biopsy | Length of biopsy specimen in millimeters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prostate biopsy fragmentation | within 21 days post biopsy | The number of sections the biopsy specimen is made of |
| Prostate biopsy length (measured after removal from biopsy chamber) | within 21 days post biopsy | Length of biopsy specimen in millimeters |
| General appearance of biopsy assessed by pathologist (biopsy quality) | within 21 days post biopsy | General quality of biopsy specimen on a scale from 0-3 (no biopsy, poor, good, excellent) |
| Prostate biopsy length (measured in biopsy needle chamber) | within 21 days post biopsy | Length of biopsy specimen in millimeters |
Other
| Measure | Time frame | Description |
|---|---|---|
| 30 day complications | 30 days after biopsy | Any complications related to the biopsy (example infection, bleeding) |
| 14 day complications | 14 days after biopsy | Any complications related to the biopsy (example infection, bleeding) |
| Pain from biopsy sampling | At the time of biopsy sampling | Numeric rating Pain Scale rating from 0-10 |
Countries
Sweden
Contacts
Primary ContactAndreas Forsvall
Backup ContactAdam Linder, Ass prof
Outcome results
None listed