Active Surveillance for Low-risk Prostate Cancer - Evaluation of the Efficacy of Minimally Invasive Active Surveillance (STHLM3AS)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
MRI+targeted biopsies+Stockholm3-test
PSA + systematic biopsies
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Active Surveillance
Eligibility Criteria
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.
Sites / Locations
- Karolinska Institutet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MRI/Fusion biopsies
Systematic biopsies
Arm Description
Stockholm3+MRI+targeted biopsies
PSA+systematic biopsies
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Predictive value of Stockholm3 test velocity
Stockholm3 test velocity
Clinically significant cut off for Stockholm3 test as a monitoring test
Stockholm3 test cutoff (0-100% risk)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03956108
Brief Title
Active Surveillance for Low-risk Prostate Cancer - Evaluation of the Efficacy of Minimally Invasive Active Surveillance
Acronym
STHLM3AS
Official Title
Active Surveillance for Low-risk Prostate Cancer - Evaluation of the Efficacy of Minimally Invasive Active Surveillance
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 12, 2019 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Active Surveillance
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI/Fusion biopsies
Arm Type
Experimental
Arm Description
Stockholm3+MRI+targeted biopsies
Arm Title
Systematic biopsies
Arm Type
Active Comparator
Arm Description
PSA+systematic biopsies
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI+targeted biopsies+Stockholm3-test
Intervention Description
MRI, evaluation in accordance with PI-RADS v2, and targeted biopsies. Stockholm3-test.
Intervention Type
Diagnostic Test
Intervention Name(s)
PSA + systematic biopsies
Intervention Description
Systematic biopsies and PSA test
Primary Outcome Measure Information:
Title
Specificity of minimally invasive active surveillance
Description
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
Time Frame
Up to five years
Secondary Outcome Measure Information:
Title
Predictive value of Stockholm3 test velocity
Description
Stockholm3 test velocity
Time Frame
Up to five years
Title
Clinically significant cut off for Stockholm3 test as a monitoring test
Description
Stockholm3 test cutoff (0-100% risk)
Time Frame
Up to five years
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only men present with prostate cancer
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Lantz, MD PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
State/Province
Solna
ZIP/Postal Code
17177
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Active Surveillance for Low-risk Prostate Cancer - Evaluation of the Efficacy of Minimally Invasive Active Surveillance
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