Condition category
Cancer
Date applied
26/12/2016
Date assigned
28/12/2016
Last edited
28/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Prostate cancer is one of the most common forms of cancer in men. Symptoms often develop slowly, over a long period of time and often involve an increased need to urinate, straining while urinating, and feeling unable to fully empty the bladder, because the enlarged prostate is pushing against the urethra (the tube that carries urine from the bladder to the penis). Diagnosing prostate cancer usually starts with measuring levels of a protein called PSA which is produced by the prostate and is higher than normal when the prostate is enlarged. Prostate cancer is often confirmed using a technique called transrectal ultrasound-guided biopsy (TRUS; a procedure where samples (cores) are taken to test in the laboratory for cancer cells). Although widely used, TRUS can sometimes miss cancerous growths and so a more accurate means of diagnosis is needed. Ultrasound CT with artificial intelligence (AI-US-CT) is a scanning technique that can potentially improve the accuracy of TRUS. The aim of this study is to find out whether AI-US-CT can improve the accuracy of TRUS with less cores being taken.

Who can participate?
Men with higher than normal PSA levels.

What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group have six samples (core biopsies) taken guided by AI-US-CT, while the patient is lying down. Those in the second group receive a traditional TRUS biopsy, where 12 samples are taken. Those in the third group also have 12 samples taken but the process is guided using a different type of scan (MRI). Participants in all groups have their results reviewed one week after the samples are taken to assess prostate cancer detection rates.

What are the possible benefits and risks of participating?
Patients could benefit from new practice of prostate biopsy with less cores (samples taken) and higher detection rate. There are no notable risks other than the general risks of complications from biopsy, such as bleeding and infection.

Where is the study run from?
1. The First Affiliated Hospital, College of Medicine, Zhejiang University (China)
2. Zhejiang University International Hospital (China)
3. Wu Jieping Urology Center (China)
4. Peking university Shougang Hospital (China)

When is the study starting and how long is it expected to run for?
January 2015 to December 2017

Who is funding the study?
Zhejiang Province Key Project of Science and Technology (China)

Who is the main contact?
1. Dr Xiao Wang (public)
2. Professor Liping Xie (scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Xiao Wang

ORCID ID

Contact details

the First Affiliated Hospital
College of Medicine
Zhejiang University
79 Qingchun Road
Hangzhou
310003
China

Type

Scientific

Additional contact

Prof Liping Xie

ORCID ID

Contact details

79 Qingchun Road
Hangzhou
310003
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AI-US-CT2016

Study information

Scientific title

A Randomized Controlled Trial To Assess and Compare the Outcomes of AI-US-CT guided Biopsy, Transrectal Ultrasound guided 12-core Systematic Biopsy, and mpMRI assisted 12-core Systematic Biopsy

Acronym

Study hypothesis

The AI-US-CT targeted 6-core biopsy illustrates a higher detection rate of prostate cancer with less cores in comparison to transrectal ultrasound guided 12-core systematic biopsy and mpMRI assisted 12-core systematic biopsy.

Ethics approval

Ethics Committee of the First Affiliated Hospital, College of Medicine, Zhejiang University, 22/02/2016, ref: 201644

Study design

Multi-centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

No participant information sheet available

Condition

Prostate cancer

Intervention

Patients are randomly assigned in a 1:1:1 ratio to one of three groups using a computer-generated list of random numbers. Patients are allocated by an independent third party to ensure that the randomization group could not be predicted.

AI-US-CT group: All transrectal ultrasound scans are performed with the patients lying in a left lateral position. Transaxial images are generated at 5 mm intervals beginning at the prostate apex and proceeding cephalad until the seminal vesicles were reached. Images are sent to AI-US-CT online-center for analysis. Six-core targeted biopsies were performed by one urologist from the third party with experience of more than 50 AI-US-CT targeted biopsy at the start of the study.

Systematic biopsy group: Patients receive traditional transrectal ultrasound guided 12-core systematic biopsy by one urologist from the third party with more than 10 years prostate biopsy experience at the start of the study.

mpMRI group: Patients undergo pre-biopsy mp-MRI of the prostate and receive mpMRI assisted 12-core systematic biopsy by one urologist from the third party with ore than 10 years prostate biopsy experience at the start of the study.

All patients receive routine anti-infective therapy. If the patient is diagnosed of prostate cancer by pathologists, he will subsequently receive operation or/and androgen deprivation therapy or/and castration therapy or/and radiotherapy according to clinical stage of the disease, otherwise PSA will be re-examined every 6 months.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Prostate cancer detection rate is assessed through medical record review 1 week post-test.

Secondary outcome measures

1. The positive rate for biopsy cores is assessed through medical record review 1 week post-test
2. The number of biopsy cores needed to detect one prostate cancer is acquired through medical record review 1 week post-test
3. In mpMRI group, the prostate cancer detection rate for each PI-RADS category is acquired through medical record review 1 week post-test

Overall trial start date

01/01/2015

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male
2. Under 85 years of age
3. Verified prostate-specific antigen (PSA) > 4 ng/ml and/or abnormal DRE
4. Provision of signed informed consent

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

120 for each group

Participant exclusion criteria

1. No signed informed consent
2. Patients who have been included in published cohorts

Recruitment start date

22/02/2016

Recruitment end date

31/03/2017

Locations

Countries of recruitment

China

Trial participating centre

The First Affiliated Hospital, College of Medicine, Zhejiang University
79 Qingchun Road
Hangzhou
310003
China

Trial participating centre

Zhejiang University International Hospital
848 Dongxin Road
Hangzhou
310000
China

Trial participating centre

Wu Jieping Urology Center
998 Qianhebei Road
Ningbo
315000
China

Trial participating centre

Peking university Shougang Hospital
9 Jinyuanzhuang Road
Bejing
100144
China

Sponsor information

Organisation

Science Technology Department of Zhejiang Province

Sponsor details

33 Huan Cheng Xi Road
Hangzhou
310000
China

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Zhejiang Province Key Project of Science and Technology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal and set the intent to publish date around one year after our overall trial end date.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Xiao Wang (zjuwangxiao@126.com)

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes