Active Surveillance for Low-risk Prostate Cancer - Evaluation of the Efficacy of Minimally Invasive Active Surveillance

Study Overview
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Brief Summary
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The STHLM3-AS study will evaluate the specificity of a new proposed protocol for active surveillance using the Stockholm3 test in combination with MRI targeted biopsies for prostate cancer detection in men with diagnosed low-risk prostate cancer undergoing active surveillance in comparison to conventional follow up using PSA and systematic biopsies.

Detailed Description
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The study design is a cross-sectional study, using a paired design, evaluating our proposed protocol (Stockholm3+MRI+targeted biopsies) versus the standard protocol (PSA+systematic biopsies). Men from the STHLM3 study, diagnosed with low risk prostate cancer and currently on AS will be invited to the study. Eligible individuals have to be alive without any severe comorbidity and without a history of initiating treatment; surgery, radiation, hormone therapy or chemotherapy. To avoid the need for additional biopsies, invitation will be synchronized with timing for planned follow-up within the AS program for each individual. At baseline blood will be drawn for PSA and Stockholm3 analyses. The patient will be asked to fill out a study specific questionnaire with questions on anxiety and quality of life. Additionally, a bi-parametric MRI evaluated in line with PI-RADS v2 guidelines will be performed. For men with PIRADS ≥ 3 targeted and systematic biopsies will be performed. For men with PIRADS<3 only systematic biopsies will be performed. Main outcome measurement will be number of detected significant cancers by each method. Further outcome measurements are the number of performed prostate biopsies with each method and level of anxiety and quality of life.

Official Title
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Active Surveillance for Low-risk Prostate Cancer - Evaluation of the Efficacy of Minimally Invasive Active Surveillance

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: MRI+targeted biopsies+Stockholm3-test
* Diagnostic Test: PSA + systematic biopsies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men in the STHLM3 study, diagnosed with a low risk prostate cancer and on AS Exclusion Criteria: History of treatment for prostate cancer; surgery, radiation, chemotherapy or hormonal treatment. Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia Contraindications for magnetic resonance imaging (MRI) e.g. pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI/Fusion biopsies<br>Stockholm3+MRI+targeted biopsies | Diagnostic Test: MRI+targeted biopsies+Stockholm3-test<br>* MRI, evaluation in accordance with PI-RADS v2, and targeted biopsies. Stockholm3-test.<br>|
| Active Comparator: Systematic biopsies<br>PSA+systematic biopsies | Diagnostic Test: PSA + systematic biopsies<br>* Systematic biopsies and PSA test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of minimally invasive active surveillance | Number of biopsies using the Stockholm3 test in combination with MRI/targeted biopsies vs. number of systematic biopsies at equal sensitivity for detecting Gleason Score ≥ 7 disease | Up to five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of Stockholm3 test velocity | Stockholm3 test velocity | Up to five years | 
| Clinically significant cut off for Stockholm3 test as a monitoring test | Stockholm3 test cutoff (0-100% risk) | Up to five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Active Surveillance