Clinical trial NCT03956108: Active Surveillance for Low-risk Prostate Cancer - Evaluation of the Efficacy of Minimally Invasive Active Surveillance
Official title: Active Surveillance for Low-risk Prostate Cancer - Evaluation of the Efficacy of Minimally Invasive Active Surveillance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Active Surveillance
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 280
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Specificity of minimally invasive active surveillance
timeFrame: Up to five years
Secondary outcomes:
measure: Predictive value of Stockholm3 test velocity
timeFrame: Up to five years
measure: Clinically significant cut off for Stockholm3 test as a monitoring test
timeFrame: Up to five years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
state: Solna
Study officials:
affiliation: Karolinska Institutet
name: Anna Lantz, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: