At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- RSI MRI (diagnostic test)
- How long the study runs
- Study runs about 67 months (dates as stated)
- About the drug or intervention
- RSI MRI — diagnostic test: In ART-Pro-1, patients receive standard of care mpMRI, with addition of the RSI sequence, and subsets of the patients' images are read separately by two expert radiologists at the center, one of whom is the standard of care radiologist (Reader 1).
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, called ART-Pro, is looking at prostate cancer. It is testing whether two types of MRI (magnetic resonance imaging) scan — a simpler 'biparametric' scan and an advanced scan that measures how water moves in tissue — can help detect prostate cancer.
Who can take part
- Age 18 or older
- Referred for a multi-parametric MRI scan of the prostate because prostate cancer is suspected
- The MRI scan is done using the study's standard ART-Pro scanning method
Who may not be able to
- Currently in prison
- Have been diagnosed with prostate cancer before
- Have an active cancer that is not prostate cancer, in parts of the body close to the prostate
- Have had prostate surgery before
- Have a hip implant
- Have metal implants or implanted devices in the body, or anything else that means the usual scanning method would have to be changed
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- Male
- Number of participants
- 500
- Started
- 2023-12-15
- Last checked
- 2024-11
Plain English Summary
What is this study?
- • Testing a new treatment for prostate cancer
- • Clinical study - 500 participants
- • This is a multicenter, multinational trial to evaluate advanced MRI techniques for improved detection of clinically significant prostate cancer (csPCa)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with prostate cancer
- • Male only
Where?
- • Cambridge - Cambridge University Hospitals NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a multicenter, multinational trial to evaluate advanced MRI techniques for improved detection of clinically significant prostate cancer (csPCa). The study will enroll 500 participants at 5 clinical centers (100 participants per center). The current standard MRI technique for prostate cancer screening is multiparametric MRI (mpMRI), but two drawbacks include need for intravenous (IV) contrast and dependence on radiologist expertise. The investigators expect that the combination of two other techniques, biparametric MRI (bpMRI) and Restriction Spectrum Imaging restriction score (RSIrs), will help non-expert radiologists achieve similar performance to expert radiologists using bpMRI or mpMRI for detection of csPCa, while avoiding the drawbacks that are present when using mpMRI.
More detail
ART-Pro will be conducted in two phases (ART-Pro-1 and ART-Pro-2) and will evaluate bpMRI, mpMRI, and RSIrs (an advanced quantitative diffusion technique), for detection of csPCa. ART-Pro-1 will evaluate these techniques prospectively, by having each patients' MRI exam read by 2 expert radiologists, both using different subsets of the images to evaluate the different techniques. ART-Pro-1 will additionally evaluate RSIrs as a stand-alone quantitative biomarker. ART-Pro-2 will evaluate these same techniques retrospectively using radiologists of varying experience levels (novice, basic, and expert), and findings will be evaluated against the expertly created dataset from ART-Pro-1. Patients will be followed after initial enrollment for the purpose of extracting relevant medical outcomes, such as biopsy results or surgery pathology.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Male only
What the study is looking for
- ✓18 years of age or older
- ✓Referred for mpMRI of the prostate for suspicion of prostate cancer
- ✓MRI is conducted using the standardized ART-Pro acquisition protocol
Who cannot take part
- ✗Currently incarcerated
- ✗Previous diagnosis of prostate cancer
- ✗Active non-prostate tumor(s) in structures of the body near the prostate
- ✗Previous prostate surgery
- ✗History of hip implant
See the full criteria
Where Is This Study? (1 UK site)
Cambridge University Hospitals NHS Foundation Trust
Cambridge CB2 0QQ, United Kingdom
How to Get in Touch
Tyler Seibert, MD, PhD
Sponsor contactCONTACT