Clinical trial · Interventional
Active Surveillance for Low-risk Prostate Cancer - Evaluation of the Efficacy of Minimally Invasive Active Surveillance
NCT03956108CI-TRIAL-00047069STHLM3AScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI+targeted biopsies+Stockholm3-test | Diagnostic Test | — | UNRESOLVED |
| PSA + systematic biopsies | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MRI/Fusion biopsies
- description
- Stockholm3+MRI+targeted biopsies
- interventionNames
- Diagnostic Test: MRI+targeted biopsies+Stockholm3-test
- type
- ACTIVE_COMPARATOR
- label
- Systematic biopsies
- description
- PSA+systematic biopsies
- interventionNames
- Diagnostic Test: PSA + systematic biopsies
Primary outcomes (1)
- measure
- Specificity of minimally invasive active surveillance
- timeFrame
- Up to five years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.