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

Prostate Cancer Clinical Trial

— STHLM3AS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956108
• Other study ID #: 2018/276-31/2
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: September 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: March 1, 2020
• Est. primary completion date: December 12, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• MRI+targeted biopsies+Stockholm3-test
MRI, evaluation in accordance with PI-RADS v2, and targeted biopsies. Stockholm3-test.
• PSA + systematic biopsies
Systematic biopsies and PSA test

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm	Solna

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Predictive value of Stockholm3 test velocity	Stockholm3 test velocity	Up to five years
Secondary	Clinically significant cut off for Stockholm3 test as a monitoring test	Stockholm3 test cutoff (0-100% risk)	Up to five years