Active Surveillance for Low-risk Prostate Cancer - Evaluation of the Efficacy of Minimally Invasive Active Surveillance (STHLM3AS)

September 9, 2020 updated by: Anna Lantz, Karolinska Institutet
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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Solna
      • Stockholm, Solna, Sweden, 17177
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity of minimally invasive active surveillance
Time Frame: 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
Up to five years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anna Lantz, MD PhD, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

December 12, 2019

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

May 15, 2019

First Submitted That Met QC Criteria

May 17, 2019

First Posted (Actual)

May 20, 2019

Study Record Updates

Last Update Posted (Actual)

September 10, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2018/276-31/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Information obtained in the study will be collected in one database. The purpose of the database is to collect study data in a proper and safe way for a long time. All information about the participants will be treated with utmost confidentiality and with strong safeguards to preserve their anonymity. Information that can be used to identify the participant (such as name, address and social security numbers) is always kept separate from other data (such as survey responses and blood tests). All questionnaire data and test results will be treated to prevent unauthorized access to them. The samples will get a unique code so that outsiders cannot identify them. The participants' samples are treated in accordance with the Swedish Biobank Act.

Everyone who works with STHLM3 are under confidentiality agreements. Results from the study are presented only as statistics in which individual answers cannot be traced.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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