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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: MRI+targeted biopsies+Stockholm3-test; Diagnostic Test: PSA + systematic biopsies

• Registration Number: NCT03956108
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-20
• Primary Completion: 2019-12-12
• Study Completion: 2020-03-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 280

Inclusion Criteria

• Men in the STHLM3 study, diagnosed with a low risk prostate cancer and on AS

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MRI/Fusion biopsies	MRI+targeted biopsies+Stockholm3-test	Stockholm3+MRI+targeted biopsies
Systematic biopsies	PSA + systematic biopsies	PSA+systematic biopsies

Primary Outcome Measures

Name	Time	Method
Specificity of minimally invasive active surveillance	Up to five years	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

Secondary Outcome Measures

Name	Time	Method
Predictive value of Stockholm3 test velocity	Up to five years	Stockholm3 test velocity
Clinically significant cut off for Stockholm3 test as a monitoring test	Up to five years	Stockholm3 test cutoff (0-100% risk)

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Solna, Sweden