Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

TRUSbx using the 18 gauge (G) 25 centimeter(cm) novel needle with 19 millimeter (mm) sample notch and a new actuator. 12 biopsies / patient.

TRUSbx using a standard tru cut biopsy needle (Mermaid Medical M-biopsy 18G 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator ( Moller Medical Blue RBG-1000-10-1000). 12 biopsies/ patient.

Trans Rectal UltraSound guided Prostate Biopsy

TRUSbx

Adam Linder, MD, PhD

Patient blinded randomized prospective trial evaluating prostate biopsy quality of a novel biopsy needle.

Prostate biopsy is the golden standard for diagnose of prostate cancer. Transrectal prostate biopsy (TRUSbx) is the most widely used technique. Due to the transrectal path the biopsy needle will bring bacteria from the colon into tissue. The patent should always receive prophylactic antibiotics to reduce the risk of clinical infection. Infections related to transrectal prostate biopsy (TRUSbx) are increasing in parallel with rising antibiotic resistance.

The investigators have in an ex-vivo setting previously shown a drastic reduction in bacterial transfer across the colon wall using a novel biopsy needle designed to minimize bacterial transfer. Biopsy of prostatectomy specimen using the novel needle has shown biopsy quality equal to the tru cut biopsy needle used today.

This is the first human pilot aiming to evaluate if biopsy quality of the novel needle is equal to the reference tru cut biopsy needle in prostate biopsy.

20 patients eligible for prostate biopsy are randomized into 2 arms (10+10 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 quality is evaluated by the pathologist blinded to device used.

Patient and pathologist are unaware of which needle/device is used. TRUSbx are taken from behind the back of the patient enabling masking from the patient.

New Biopsy Needle - Evaluation of Prostate Biopsy Quality

Prospective Patient Blinded Randomized Trial Comparing Biopsy Specimen Quality in a Novel Biopsy Needle and Actuator Compared to Todays Standard Tru Cut Needle and Actuator.

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)

Region Skane

Multispectral 3 Tesla MRI imaging with contrast followed by biopsy

MS3TMRI

Masoom Haider, MD

MultiSpectral 3 Tesla MRI (MS3TMRI) can increase the yield of Trans Rectal Ultrasound Biopsy (TRUSBx) to improve identification of patients on active surveillance requiring treatment.

This is a prospective single arm study. 120 patients at risk for significant occult prostate cancer on an active surveillance program will undergo MS3TMRI followed by a standard TRUSBx and additional biopsies guided by the MS3TMRI results. The positive predictive value (PPV) of MS3TMRI-TRUSBx for cancer requiring consideration of therapy will be compared to the PPV of TRUSBx alone. MS3TMRI consists of T2, diffusion-weighted imaging (DWI), dynamic contrast enhanced MRI (DCEMRI), proton MR spectroscopy (MRS) interpreted by a radiologist and by CAD methods validated on whole mount prostate specimens.

The Value of MultiSpectral 3 Tesla MRI in Active Surveillance of Prostate Cancer

To Determine if MultiSpectral 3 Tesla MRI Can Provide Added Value in the Detection of Significant Cancers in Patients o n Active Surveillance for Prostate Cancer

Compare the targeted biopsy to the random biopsies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
New Biopsy Needle - Evaluation of Prostate Biopsy Quality	NCT04091230	Prostate Cancer...	TRUSbx	40 Years - 90 Years	Region Skane
The Value of MultiSpectral 3 Tesla MRI in Active Surveillance of Prostate Cancer	NCT01896713	Prostate Cancer	MS3TMRI	18 Years -	Sunnybrook Health Sciences Centre
The Value of MultiSpectral 3 Tesla MRI in Active Surveillance of Prostate Cancer	NCT01896713	Prostate Cancer	MS3TMRI	18 Years -	Sunnybrook Health Sciences Centre

Spots Global Cancer Trial Database for trusbx

Every month we try and update this database with for trusbx cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for trusbx

Every month we try and update this database with for trusbx cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for trusbx cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.