Clinical trial NCT03648359: Multiparametric MRI in Men With Prostate Cancer Enrolled in Active Surveillance
Official title: Multiparametric MRI in Men With Prostate Cancer Enrolled in Active Surveillance
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Prostatic Neoplasms
Keywords: Prostate biopsy
Prostate cancer
Magnetic resonance imaging
Neoplasm staging
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To investigate whether multiparametric MRI (mp-MRI) in patients with low-risk prostate cancer can improve the selection of patients suitable for Active Surveillance and have a relevance in the ongoing monitoring

Detailed description: Men with localized prostate cancer (PCa) with small tumor burden may be followed on active surveillance (AS) rather than active treatment. AS is an attempt to avoid over-treatment of PCa, which is estimated to be insignificant at the time of diagnosis, and therefore unlikely to affect patient morbidity and mortality. AS include close monitoring with PSA measurement (blood test), digital rectal exploration (DRE) and trans-rectal ultrasound-guided prostate biopsy (TRUS-bx) at regular intervals, so that active treatment can be initiated if the cancer becomes more aggressive. It is crucial that patients undergoing AS are staged correctly, to avoid underestimating more aggressive disease and patients mistakenly are enrolled into AS instead of active treatment.

Previously, a PhD study conducted at Herlev Hospital revealed that multiparametric MRI (mp-MRI) of the prostate can improve the detection and staging of PCa and may add additional information about tumor aggressiveness compared to the traditional methods DRE and TRUS-bx. Mp-MRI at the inclusion of AS may detect missed significant tumors and potential areas of higher aggressiveness than detected by the traditional biopsies. Additional targeted biopsies from these suspicious areas can then be performed with a re-evaluation of the treatment plan, if more advanced disease is identified. Conversely, mp-MRI has a high negative predicted value for significant disease and can be used to rule out significant PCa, reassuring patients and physicians to go on with AS. Mp-MRI has been used at the Urology Department, Herlev Hospital, since 2013 in the diagnosis of PCa and in the evaluation of patients undergoing AS. A retrospective study have show that mp-MRi improve the detection of missed significant PCa.

The main objective of this study is now to prospectively investigate, whether mp-MRI can improve the selection of patients suitable for Active Surveillance and have a relevance in the ongoing monitoring.

Eligibility criteria: Inclusion Criteria:

* Patients with low risk localized prostate cancer enrolled in active surveillance

Exclusion Criteria:

* Metastatic prostate cancer
* No mp-MRI data present
* Prostate cancer treatment
* Known allergic reaction to Gadolinium-based MRI contrast agent
* Prostate biopsy during the last 21 days
* Impaired renal function with GFR \< 30 ml / min
* pacemaker
* Magnetic metal residues in the body
* Claustrophobia
* Psychiatric disorders
* Age under 18 year

Primary outcomes:
measure: Changes in treatment from active surveillance (observation) to active treatment based on mp-MRI results.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Urology, Herlev University Hospital Herlev
Study officials:
affiliation: Department of Urology, Herlev University Hospital Herleb, Herlev, Denmark, 2730
name: Lars Boesen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: