Biopsy diagnosis of prostate cancer in patients with suspected prostate cancer undergoing their first biopsy: comparison of target biopsy alone vs target biopsy in addition to standard biopsy
| ISRCTN | ISRCTN60263108 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60263108 |
| Secondary identifying numbers | 3524 |
- Submission date
- 31/01/2022
- Registration date
- 09/03/2022
- Last edited
- 11/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Recently, thanks to the introduction of multiparametric prostate magnetic resonance imaging (mp-MRI scans), it is possible to perform targeted prostate biopsies (tissue samples) on patients with suspected prostate cancer with the intent to reduce the number of samples per single biopsy, increasing the diagnostic accuracy. While performing a targeted biopsy alone in patients with positive mp-MRI and a negative previous random biopsy is a well-validated practice, this method is still under scrutiny in the setting of patients undergoing their first biopsy. The aim of this study is to compare the prostate cancer detection rate of a diagnostic pathway based on target biopsy samples versus a diagnostic pathway based on target biopsy samples plus random samples.
Who can participate?
Patients aged under 75 years with an indication for a prostate biopsy for suspected prostate cancer and positive mp-MRI
What does the study involve?
Participants are randomly allocated to either a diagnostic pathway based on target biopsy samples or a diagnostic pathway based on target biopsy samples plus random samples. The detection rate of clinically significant prostate cancers is compared between the two pathways.
What are the possible benefits and risks of participating?
The benefit of this study is a reduction in the number of biopsy samples, with a likely reduction in the duration and side effects of the procedures. About 5-7% of clinically significant prostate cancers are diagnosed only at standard biopsy with negative target samples. To avoid the risk of missed diagnosis, patients enrolled in the study who are biopsy negative undergo close follow-up.
Where is the study run from?
San Luigi Gonzaga University Hospital (Italy)
When is the study starting and how long is it expected to run for?
January 2019 to October 2021
Who is funding the study?
San Luigi Gonzaga University Hospital (Italy)
Who is the main contact?
Prof. Francesco Porpiglia
porpiglia@libero.it
Contact information
Principal Investigator
San Luigi Gonzaga University Hospital
Regione Gonzole 10
Orbassano (Turin)
10043
Italy
 ORCID ID |
0000-0002-0752-4857 |
|---|---|
| Phone | +39 (0)119026485 |
| porpiglia@libero.it |
Study information
| Study design | Single-centre interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | Biopsy diagnosis of prostate cancer in naïve patients. Comparison of target biopsy alone vs. target biopsy in addition to random: a prospective randomized trial |
| Study objectives | To compare, in naïve patients with suspected prostate cancer and positive multiparametric prostate magnetic resonance imaging (mp-MRI), the detection rate of clinically significant prostate cancer of a diagnostic pathway based on target biopsy samples vs a diagnostic pathway based on target biopsy samples plus random samples. |
| Ethics approval(s) | Approved 07/03/2019, Ethics Committee San Luigi Gonzaga Hospital (regione gonzole 10, Orbassano (TO), 10043, Italy; +39 (0)11 9026204, +39 (0)11 9026 566; sperimentazioni@sanluigi.piemonte.it), ref: 3524 |
| Health condition(s) or problem(s) studied | Prostate cancer |
| Intervention | The primary objective of the study is to compare, in naïve patients with positive MRI, the detection rate of clinically significant prostate cancer of a diagnostic pathway based on target biopsy samples vs a diagnostic pathway based on target biopsy samples plus random samples. The patients underwent two-arm randomization via specific "query" to the website https://www.randomization.com. Patients were randomly assigned to undergo fusion biopsy alone (Group A) or fusion biopsy plus standard biopsy (Group B). Transrectal ultrasound was performed using a Hawk Ultrasound scanner 2102 EXL with a biplanar transducer, biopsies were performed using a disposable 18-gauge biopsy gun with a specimen size of 18–22 mm. Fusion biopsy was executed using the BioJet fusion system, for patients enrolled in Group B, in accordance with the protocol by Rodríguez-Covarrubias et al, a standard biopsy was performed obtaining 12 cores via a transrectal approach. The Gleason score (GS) of the biopsy, number of total and positive cores, total and maximum cancer core length (CCL) and maximum cancer core invasion (CCI) rate were acquired in accordance with the standards of reporting for MRI targeted biopsy studies (START) criteria. Clinical significant Prostate Cancer (csPCa) was defined when START criteria for target biopsy (biopsy GS ≥7 or maximum CCL ≥5 mm) and updated Epstein criteria for Standard Biopsy were met. Prostate specimens from patients who underwent robot-assisted radical prostatectomy (RARP) were chosen as the reference standard. The organ’s processing was executed following the aforementioned technique, subsequently calculating GS and ISUP grade for each lesion found. 30-days biopsy related complications were classified according to the Clavien–Dindo classification. The Detection Rate was set as the ratio between the total cases of PCs/csPCs diagnosed thanks to a particular biopsy (FB, FB + SB or SB) and the total number of patients. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Detection rate (DR) of clinically significant prostate cancer (csPCa) by fusion biopsy alone (Group A) versus fusion biopsy plus standard biopsy (Group B), set as the ratio between the total cases of csPCs diagnosed and the total number of patients. Evaluated after the histological examination. |
| Secondary outcome measures | 1. 30-days biopsy related complications classified according to the Clavien–Dindo classification at 30-days follow up 2. The overall DR of prostate cancer by fusion biopsy alone (Group A) versus fusion biopsy plus standard biopsy (Group B). Evaluated after the histological examination. 3. Whole-mount histopathological findings after RARP compared with biopsy findings in both study groups, evaluated after the histological examination |
| Overall study start date | 01/01/2019 |
| Completion date | 15/10/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Male |
| Target number of participants | 384 |
| Total final enrolment | 384 |
| Key inclusion criteria | 1. Age <75 years 2. Negative history of previous prostate biopsies 3. Suspected serum prostate-specific antigen (PSA) values <15 ng/ml 4. Negative rectal examination (DRE) 5. Positive multiparametric magnetic resonance imaging |
| Key exclusion criteria | Contraindications to prostate biopsy (e.g., inability to discontinue anticoagulant therapy) |
| Date of first enrolment | 11/04/2019 |
| Date of final enrolment | 01/10/2021 |
Locations
Countries of recruitment
- Italy
Study participating centre
Orbassano (Turin)
10043
Italy
Sponsor information
Hospital/treatment centre
Regione Gonzole 10
Orbassano
10043
Italy
| Phone | +39 (0)119026678 |
|---|---|
| urologia.deg@sanluigi.piemonte.it | |
| Website | http://www.sanluigi.piemonte.it/ |
"ROR" |
https://ror.org/04nzv4p86 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 03/08/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | primary results | 10/01/2023 | 11/01/2023 | Yes | No |
Editorial Notes
11/01/2023: Publication reference and total final enrolment added.
03/02/2022: Trial's existence confirmed by the Ethics Committee San Luigi Gonzaga Hospital.
