Imperial Prostate 9 - ATLAS (Approaches To Long-Term Active Surveillance)
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorImperial College London
About this trial
The goal of this intervention study is for patients on active surveillance for prostate cancer, to demonstrate that use of regular MRI scans is better able to detect cancer progression over 5 years compared to the current NICE defined strategy.
Research Question P - In patients who are on active surveillance for low to medium risk prostate cancer, I - is the use of regular MRI scans C - compared to current NICE defined standard of care, O - better at detecting cancer progression with less cost to the NHS (fewer PSA tests, biopsies and clinic visits)?
Patients will be allocated in a 1.1 ratio to either MRI scans or the current NICE defined standard. Randomisation will be blocked (random block size) and stratified by MRI visibility of lesions (3 categories \[ no visible lesion, diffuse changes, discrete visible lesion\]), cancer Grade Group (GG1, GG2) and time since diagnosis. This study will not be blinded to patients or physicians.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or above (no upper limit)
Patients with a prostate (either cis-male gender or trans-female gender with no prior androgen deprivation hormone use at all).
Diagnostic bi-parametric or multiparametric MRI
Diagnostic systematic biopsy +/- targeted biopsy
Disqualifiers
On active surveillance for greater than 9 months prior to screening date.
Contraindication to MRI or gadolinium contrast
Previous hip replacement to both hips
Contraindication to performing a biopsy guided by a transrectal ultrasound probe
Trial design
Design model
Factorial
Treatments tested in this trial
MRI Scans
Diagnostic testThe regular use of MRI in active surveillance will lead to greater confidence in active surveillance for patients with low and medium risk prostate cancer. This is because such a strategy is likely to detect cancer progression earlier with fewer invasive biopsies. Those patients randomised to the intervention arm will have additional MRI scans. These will be non-contrast so there is no risk from having repeated 1-2 yearly injections of gadolinium contrast. Patients with contraindications to MRI will not be taking part in the study so will not be exposed to an unnecessary MRI. Patients with a visible lesion or medium risk cancer will have PSA 6 monthly and MRI annually. All other patients will undergo PSA 6 monthly and MRI in years 1, 3 and 5. In all patients, a targeted biopsy will be carried out if the MRI PRECISE score is \>/=4.
Treatment groups
1,263 Participants
are divided into 2 treatment groupsGroup A: Standard care (Control) ArmNo intervention 0 interventions
Group B: Intervention ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Biopsy
Progression in each group defined as higher risk cancer on biopsy (Grade Group \>/=3) Prostate cancer progression rates and time to progression in each randomised arm defined on, • biopsy: grade progression to Grade Group 3 or greater or detection on biopsy of intraductal cancer or lymphovascular invasion. Many of our clinicians would include patients on active surveillance with cribriform pattern on Grade Group so this is not a factor for progression.
Time frame
5 Years2
Staging
Progression in each group defined as higher risk cancer on higher stage (\>/=T3 or \>/=N or \>/=M1) over 5 years. Prostate cancer progression rates and time to progression in each randomised arm defined on, • staging: cancer has spread to surrounding tissues (extracapsular), lymph node involvement or distant body parts as demonstrated on cross-sectional imaging including MRI, CT, bone-scan or PET scans as deemed appropriate by the local multidisciplinary cancer team.
Time frame
5 YearsSecondary outcomes
1
Cost-effectiveness
Cost-effectiveness of revising the prostate cancer active surveillance protocol to incorporate regular surveillance MRI within the NHS (QALYs questionnaire).
Time frame
5 Years2
Biopsy Measurement
Biopsy would be recommended when there is a change on the MRI or if there is a consistent rise in PSA over 3 readings that is concerning for progression even if the MRI shows no change and other factors such as infection or prostatitis have been ruled out.
Time frame
5 years3
MRI & biopsy-related adverse events
Patients will be asked to self-report pain and discomfort (referred to as pain hereafter) immediately after and seven days after biopsy on a 4-point Likert-type scale as none, mild, moderate, or severe. Specific related complications such as fever, flu-like shivers, pain, haematuria, haematochezia, and haemoejaculate will be self-reported at 35 to 90 days after prostate biopsy as absent or present following biopsy on a purpose designed questionnaire. For each symptom, patients will be asked to score the degree of "problem" as none, minor, moderate, or major. This will be used to derive a binary outcome for each symptom (present/moderate/severe problem vs. absent /minor problem).
Time frame
5 Years4
Treatment
Patients treatment options for progressive disease will be collected through multidisciplinary team (MDT) outcomes in the clinical records and clinic letters or entries by clinicians in the health records. Such options depending on cancer risk include; active surveillance, focal therapy, radical surgery or radiotherapy (with some men started on androgen deprivation therapy).
Time frame
5 YearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Imperial College London
Lead sponsor
Queen Mary University of London
Collaborator
University of Leeds
Collaborator
University College, London
Collaborator
University of York
Collaborator
University College London Hospitals
Collaborator
Source ClinicalTrials.gov