Multiparametric MRI in Men With Prostate Cancer Enrolled in Active Surveillance

Herlev Hospital

Status: Invitation-only

Conditions: Prostatic Neoplasms

Treatments: Procedure: multiparametric MRI Diagnostics

Study type: Interventional

Funder types: Other

Identifiers

NCT03648359

AS (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Enrolled AS patients

Other group

Description:

Patients with prostate cancer enrolled i active surveillance protocol using PSA, digital rectal examination and conventional TRUS-biopsies

Treatment:

Procedure: multiparametric MRI Diagnostics