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Genital Diseases, Male

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Male Urogenital Diseases

Participants will undergo mpMRI. Blinding will not be possible. Once the MRI report is issued, the local clinical team will make a decision about advising whether a biopsy is necessary or not.

Participants will undergo bpMRI. Blinding will not be possible. Once the MRI report is issued, the local clinical team will make a decision about advising whether a biopsy is necessary or not.

Randomisation 2 will only be relevant if participants are advised by their clinical team to have a biopsy based on their MRI and other clinical factors. Participants advised to have a biopsy will undergo a visual estimation targeted biopsy

Randomisation 2 will only be relevant if participants are advised by their clinical team to have a biopsy based on their MRI and other clinical factors. Participants advised to have a biopsy will undergo an image fusion targeted biopsy.

biparametric MRI takes 30-40 minutes and requires a contrast injection called gadolinium (like a dye). This is also called long MRI and is most commonly used in the NHS.

bpMRI

During image fusion targeted biopsy, the biopsy operator uses the MRI scans that were taken beforehand but laid on top of the live ultrasound images during the biopsy. This uses software and takes a few minutes longer to perform. Once the MRI images and ultrasound images are 'fused', the actual biopsies are taken as normal.

Image-Fusion targeted and systematic Biopsy

Hashim Ahmed

Thiagarajah Sasikaran

To evaluate the role of biparametric MRI and image-fusion targeted biopsies for the detection of prostate cancer.

To determine whether biparametric MRI (bpMRI) could be recommended as an alternative to multiparametric MRI (mpMRI) for the detection of clinically significant prostate cancers in patients at risk.

To determine whether image-fusion targeted biopsy is better than visual-registration (cognitive) targeted biopsy at detecting clinically significant prostate cancers in patients requiring prostate biopsy due to a suspicious MRI.

Background and study aims:

The aim of this study is to improve the way prostate cancer is diagnosed by looking at two different types of MRI scans and two different types of prostate biopsy (tissue samples). A large study such as this is required to help the NHS decide how to diagnose prostate cancer in the future. If a person is suspected of having prostate cancer, then they are referred by their GP. At the hospital clinic, the participant will then have an MRI scan. If this scan shows that cancer might be present, then the doctor will usually suggest that the patient has a biopsy. There are two ways of doing a prostate MRI. One takes 30-40 minutes and requires a contrast injection called gadolinium (like a dye). This is called long MRI and is most commonly used in the NHS. Gadolinium is safe as it rarely causes any bad reaction but using it means that the scan takes more time. Another type of MRI takes 15-20 minutes and does not use gadolinium contrast. This is called a short MRI. Many studies over the last 5 years have shown that the long and short MRIs are similar in their accuracy in diagnosing important prostate cancer. These studies have not been of high quality or large enough to change NHS practice. Patients with suspicious areas on the MRI are usually advised to have a prostate biopsy. This involves taking tissue samples using a needle. The samples are then looked at under the microscope by a pathologist to see if cancer cells are present. There are two ways of doing a prostate biopsy. One is where the person doing the biopsy decides where to put the biopsy needle by looking at the MRI scans that have been already taken on a computer screen. The needle is guided to the prostate using live ultrasound scans that are shown on a different screen near the patient. The biopsy operator makes a judgement about where to place the biopsy needles. This is called visual registration. Tissue samples from other areas of the prostate that look normal on the MRI scans are also taken to ensure cancer is not missed. The other type of biopsy is called image fusion. During image fusion biopsy, the biopsy operator uses the MRI scans that have been taken beforehand but laid on top of the live ultrasound images during the biopsy. This uses software and takes a few minutes longer to perform. Once the MRI images and ultrasound images are 'fused', the actual biopsies are taken as normal. Studies over the last 5 years have shown mixed results. Some have shown that image fusion biopsy is no better than visual registration biopsy, whilst a few have shown it might make a difference in improving cancer detection. As a result, it is not known for certain which way is better. A large study is needed to show whether the investigators need to do image fusion or not, in order for the NHS to decide whether or not to use it in all hospitals doing prostate biopsies.

two linked RCTs which will test whether bpMRI and image-fusion make a difference if used in clinical practice, across multiple centres, without the incorporation bias inherent in paired-cohort studies

Patients with a prostate (either cis-male gender or trans-female gender with no prior androgen deprivation hormone use at all)

Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer

Evaluating the Role of Biparametric MRI and Image-fusion Targeted Biopsies for Detection of Prostate Cancer

Proportion of clinically significant cancers, defined as any amount of Gleason ≥3+4 (ISUP Grade Group ≥2) on biopsy, detected in the randomised population of patients at risk.

Proportion of clinically significant cancers, defined as any amount of Gleason ≥3+4 (ISUP Grade Group ≥2) on biopsy, detected in the randomised population of patients biopsied for a suspicious MRI.

MRI related adverse events measured using documentation

MRI related serious adverse events measured using documentation

biopsy-related adverse events measured using documentation

biopsy-related serious adverse events measured using documentation

The proportion of patients advised to undergo a needle biopsy. The researchers will document common reasons for patients who are advised to undergo a biopsy or advised against a needle biopsy and still choose to have a biopsy.

The proportion of patients undergoing a prostate biopsy after MRI. The researchers will document common reasons for patients who are advised to undergo prostrate biopsy after MRI.

The proportion of patients diagnosed with clinically significant prostates cancers defined as any Gleason 3+3=6 on needle biopsy carried out after MRI.

The proportion of patients diagnosed with clinically significant prostate cancers using other histological thresholds on prostate biopsy carried out after MRI.

The researchers will evaluate these proportions by MRI score at patient and lesion level (on a scale of 1 to 5) and by the presence or absence of clinical risk parameters.

The proportion of patients diagnosed with clinically significant prostate cancers using all histological thresholds on targeted biopsy using four targeted cores

The proportion of patients diagnosed with clinically significant prostate cancers using all histological thresholds on targeted biopsy using six targeted cores

Detection rates for each randomised group of known prognostic risk categories. These are D' Amico, National Comprehensive Cancer Network (NCCN) and Cambridge Prognostic Groups (CPG).

A comparison of the two MRI scoring systems, Likert and PIRADS (the latest version as defined in MRI Reporting SOP), in terms of the proportion of patients biopsied and subsequently diagnosed with clinically significant and clinically insignificant prostate cancer, using each of the histological thresholds, on a prostate biopsy.

Characteristics of cancer in targeted versus systematic biopsies by MRI score, PSA, PSA density, age, ethnicity, family history and history of prior prostate biopsy with a multivariable evaluation to determine whether patients might avoid systematic sampling in the future.

External validation of the Imperial RAPID Risk Score (MRI+) within each randomised group of the IP7-PACIFIC study, external validation

External validation of Imperial Rapid Access to Prostate Imaging and Diagnosis(RAPID) Risk Score (Systematic+) within each randomised group of the IP7-PACIFIC study, external validation

Impact of prostate biopsy in each randomised group on patient-reported outcomes using a survey that includes EQ-5D-5L health-related quality of life questionnaire

Impact of prostate biopsy in each randomised group on patient-reported experience measures using version of the Prospective cohort study (Prostate Biopsy Effects: ProBE) questionnaire.

Analysis of biopsy rates in cancer detection (by all histological thresholds) in the randomised group will be conducted by centre using centre size.

MRI scanner type (1.5 Tesla vs. 3.0 Tesla), type of biopsy route used (transrectal vs trans perineal), number of systematic biopsies taken (limited systematic vs extended systematic biopsy), type of analgesia/anaesthetic (local anaesthetic, sedation or general anaesthetic) as additional stratification factors

Cancer Research UK

National Institute for Health Research, United Kingdom

Imperial College London

The cohort consists of patients:

* with age 50-69 years
* without any contraindications to MRI or biopsy
* without known status of prostate cancer or prostate biopsy in the past (interventions for BPH are not a restriction)
* without known BRCA mutation
* without PSA test or prostate MRI in the past 2 years
* without any signs of prostatitis or urinary tract infection in the past 6 months.

biparametric MRI with protocol including anatomical T2 sequence and diffusion-weighted images (DWI), according to the standards

magnetic resonance

testing of prostate-specific antigen (PSA) in serum

serum PSA examination

Men with a positive MR test are planned for a targeted MRI/US fusion and systematic prostate biopsy.

Men with a positive blood marker (either PSA, PSAD, or PHI) are planned for a systematic 12 core biopsy. Positive test results are PSA ≥ 3, integrated marker PSAD ≥ 0.15, and PHI ≥ 35.

Biopsy

Michal Standara, MD

Jan Křístek, MD, PhD

Jan Kristek, Ph.D., MD

Michal Stanik, Ass.Prof.

Jan Kristek, PhD

Alexandr Poprach, Ass.Prof.

Milos Pacal, MD

Iva Babankova, MD

David Miklanek, MD

Michal Staník, MD,PhD.

Prostate cancer is one of the most common malignancies in the male population with incidence and mortality rates comparable to breast cancer in women, but in contrast, a population screening program that would fulfill all the recommended criteria is not yet available. According to international recommendations, the preventive PSA sampling used in clinical practice is not suitable because of the concurrent detection of clinically insignificant carcinomas in a major proportion of tests. These clinically non-significant cancers make up a significant and increasing proportion with age. Detection of non-significant cancers burdens the health care system and patients with the care that has no positive impact on their health. Current preventive serum prostate-specific antigen (PSA) testing does not distinguish benign hyperplasia and nonsignificant carcinoma from clinically significant cancer. It is therefore not suitable for full-scale screening.

According to current guidelines, magnetic resonance imaging (MRI) is indicated only in patients with an increased risk of cancer for detection or staging after biopsy and is not used for screening. According to recent studies, MRI has detected an increased proportion of significant cancers in the general population compared to screening based on PSA, while fewer clinically insignificant cancers have been detected. In screening, a shorter examination protocol without contrast medium (biparametric MRI) is used with a lower cost per examination, allowing to increase both the number of patients examined and patient comfort.

The main objective of the project is to assess the contribution of imaging in the screening of clinically significant prostate cancer and to validate the published results in the Czech population, and extend the screening model by the second round of examinations and additional laboratory markers. The secondary aim is to design a subsequent study with a larger number of participants allowing statistical evaluation, similar to the successful breast cancer screening.

A prospective cross-sectional (with a longitudinal component, 2nd screening round) study evaluating the possibility of using the biparametric MRI protocol technique for screening clinically significant prostate cancer in men from the general population.

Tests performed:

* Serum PSA
* PHI calculation (Prostate Health Index) to be performed only if the PSA values are in the range of 2-10 ng/l
* MRI of the prostate (abbreviated biparametric protocol)
* Digital rectal examination (DRE) as part of a clinical visit at a urologist in patients with a positive PSA test
* Biopsy - if indicated

MRI specifications:

* Protocol with anatomical T2 sequence and diffusion-weighted images (DWI), according to the standards
* Typical complete examination time does not exceed 20 minutes, planned acquisition time less than 15 minutes.
* No contrast agent or spasmolytics is injected.

Blinding:

* Every test evaluator (radiologist/urologist) does not know the results of other tests. · MRI reports entered in the registry obligatorily before the biopsy.
* The patient is not informed which test was positive and resulted in an indication for biopsy.
* The pathologist does not know the results of MRI or laboratory tests.

The sequence of tests:

The MRI is assessed with the PI-RADS 2.1 system, each finding is reported on a scale of 1-5. To minimize the detection of non-significant cancers and to reduce the number of biopsies according to the results of the IP1-Prostagram study, a PI-RADS value of 4-5 was chosen as a positive test representation.

Consensual double reading by 2 experienced uroradiologists (at least 400 MRI of the prostate read by the beginning of the study). Men with a positive MRI test are planned for a targeted MRI/US fusion and systematic prostate biopsy.

Men with a positive blood marker (either PSA, PSAD, or PHI) are planned for a systematic 12 core biopsy. Positive test results are PSA ≥ 3, integrated marker PSAD ≥ 0.15, and PHI ≥ 35.

Study participants are invited to repeat the screening tests after 2 years by letter. If they do not respond to a written offer, also by e-mail and SMS.

Definition of clinically significant cancer: • ISUP Grade Group ≥ 2.

A prospective cross-sectional (with a longitudinal component, 2nd screening round) study evaluating the possibility of using the abbreviated bpMRI protocol technique for screening clinically significant prostate cancer in men from the general population.

Due to the nature of examined organ (prostate), this study is focused exclusively on men.

Prostate Cancer Screening With Abbreviated MRI Protocol

ProstaPilot: Prostate Cancer Screening Using MRI With an Abbreviated Protocol

Proportion of positive MRI findings (PI-RADS 4+) in the general population of men aged 50-69 years.

Distribution of PI-RADS scores (proportion of individual scores 1-5) in the screened population.

Ratio of significant and non-significant cancers in individual categories of PI-RADS scores in patients indicated for biopsy.

Concordance rate (%) between radiologists performing MRI scoring.

Number of participants who agreed to be included in the study through used recruitment strategies.

Number of participants who contacted the team themselves with a request for testing.

Number of participants who signed the informed consent and were enrolled in the study.

Number of participants who visited a screening facility.

Number of participants who completed the designated examination.

Costs of individual inclusion and screening tests.

Numbers and reasons of participants who did not complete scheduled tests, follow-up examinations, or withdrew informed consent.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer	NCT05574647	Prostate Cancer Adenocarcinoma Prostatic Neopl... Prostatic Disea... Neoplasms	bpMRI Image-Fusion ta...	18 Years -	Imperial College London
Prostate Cancer Screening With Abbreviated MRI Protocol	NCT05603351	Prostate Cancer	magnetic resona... serum PSA exami... Biopsy	50 Years - 69 Years	Masaryk Memorial Cancer Institute

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