## Protocol Section
### Identification Module
**NCT ID:** NCT06420115

**Acronym:** TARGET

**Brief Title:** Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects?

**Official Title:** AOP2780 - Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects?

#### Organization Study ID Info
**ID:** AOP2780
#### Organization
**Class:** OTHER
**Full Name:** University Hospital Padova
### Status Module
#### Completion Date
**Date:** 2025-05-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-25

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-26
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital Padova

#### Responsible Party

**Investigator Affiliation:** University Hospital Padova

**Investigator Full Name:** FABIO ZATTONI

**Investigator Title:** MD, Phd

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Differences in terms of diagnostic capability and side effects related to the needle caliber used for prostate biopsy sampling in patients with suspected prostate cancer

**Detailed Description:** To assess whether a larger caliber (16G) prostate biopsy needle increases the diagnostic capability of prostate neoplasia compared to a smaller caliber (18G) needle, while keeping perioperative complications constant.

### Conditions Module

**Conditions:**

- Prostate Cancer Diagnosis

**Keywords:**

- pca

- needle

- 16 gauge

- 18 gauge

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 580

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: different needle size for prostate biopsy

**Label:** mpMRI target prostate biopsy with 16 gauge needle

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Device: different needle size for prostate biopsy

**Label:** mpMRI target prostate biopsy with 18 gauge needle

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- mpMRI target prostate biopsy with 16 gauge needle

- mpMRI target prostate biopsy with 18 gauge needle

**Description:** MRI Fusion Transperineal Prostate Biopsy

**Name:** different needle size for prostate biopsy

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** The primary outcome measure involves assessing the total number of biopsies, including both random and fusion-targeted approaches, that reveal the presence of prostate cancer.

**Measure:** Total number of random and fusion-target biopsies with presence of prostate cancer

**Time Frame:** When histological report available

**Description:** The primary outcome measure focuses on the number and the detection rates of random and fusion-target biopsies revealing clinically significant prostate cancer aof clinically significant prostate cancer (defined as ISUP \>=2) between 16-gauge and 18-gauge biopsy needles.

**Measure:** Number of random and fusion-target biopsies with clinically significant prostate cancer (defined as International Society of Urological Pathology >=2)

**Time Frame:** When histological report available

#### Secondary Outcomes

**Description:** Neoplasia/core ratio, indicates the ratio of neoplastic tissue to healthy tissue within biopsy cores obtained through both 16 and 18 gauge biopsies for prostate cancer diagnosis. By analyzing this ratio, investivators seek to identify differences in diagnosis across the two different sizes

**Measure:** Neoplasia/core ratio for each random and fusion-target biopsy

**Time Frame:** When histological report available

**Description:** The validated pain questionnaire employed in this study is designed to comprehensively assess the intra- and perioperative pain (following 7 days) experienced by patients undergoing prostate biopsy procedures with 18G and 16G needles. The visual analog scales "VAS" is a standardized validated questionnaire, a horizontal line, where one end represents "1 - no pain" and the other end represents "10 - worst possible pain." Patients are asked to mark on the line the point that best represents the intensity of their pain.

**Measure:** Intra- and perioperative pain with 18G and 16G needles assessed using visual analog scale (VAS)

**Time Frame:** 30 days

**Description:** By tracking the number of hospitalizations occurring at both 30 and 60 days post-procedure among patients undergoing prostate biopsy within these specific time frames, researchers seek to assess the short-term post-procedural outcomes and potential complications associated with the biopsy procedure. These hospitalization data will provide information into the safety profile and healthcare utilization patterns following prostate biopsy, aiding in the optimization of patient care and risk management strategies.

**Measure:** Number of hospitalizations at 30 and 60 days post-procedure

**Time Frame:** 60 days from biopsy

**Description:** Intraoperative complications refer to adverse events occurring during the biopsy procedure itself, while perioperative complications encompass those arising in the immediate post-procedural period. These complications may include but are not limited to bleeding, infection, urinary retention, and vasovagal reactions. By documenting these complications, investigators will evaluate the safety profile and potential risks associated with each needle gauge, thereby informing clinical decision-making and optimizing patient outcomes.

**Measure:** Number of intra- and perioperative complications associated with 18G and 16G needles

**Time Frame:** 30 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Clinical suspicion of prostate cancer (presence of elevated prostatic specific antigen and/or suspicious digital rectal examination);
* Presence of at least one suspicious prostate lesion on MRI (Prostate Imaging-Reporting and Data System ≥ 3) according to the Prostate Imaging-Reporting and Data System v2.1 performed before Magnetic Resonance Imaging/transrectal ultrasound fusion biopsy.

Exclusion Criteria:

* Patients under active surveillance or with a previous diagnosis of prostate neoplasia prior to biopsy.
* Previous radiotherapy to the prostate for neoplasia.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** fabio.zattoni@unipd.it

**Name:** Fabio F. Zattoni, MD, PhD

**Phone:** 0498212730

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Padua

**Contacts:**

***Contact 1:***

- **Email:** fabio.zattoni@unipd.it

- **Name:** Fabio Zattoni, MD, PhD

- **Role:** CONTACT

***Contact 2:***

- **Email:** filippo.carletti@aopd.veneto.it

- **Name:** Filippo Carletti, MD

- **Role:** CONTACT

**Country:** Italy

**Facility:** Urology Unit - Padua University Hospital

**Status:** RECRUITING

**Zip:** 35100

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Surgery, Oncology and Gastroenterology, Urology Clinic, University of Padua, Padova,

**Name:** Fabio Zattoni, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** Only if requested

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005834

- Term: Genital Neoplasms, Male

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: HIGH

- As Found: Prostate Cancer

- ID: M8946

- Name: Genital Neoplasms, Male

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011471

- Term: Prostatic Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
