Multiparametric MRI in Men With Prostate Cancer Enrolled in Active Surveillance

• ClinicalTrials.gov Identifier: NCT03648359
• Recruitment Status: Enrolling by invitation
• First Posted: August 27, 2018
• Last Update Posted: November 13, 2020
• Sponsor: Herlev Hospital
• Information provided by (Responsible Party): Lars Boesen, Herlev Hospital

Study Description

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

Condition or disease	Intervention/treatment	Phase
Prostatic Neoplasms	Procedure: multiparametric MRI Diagnostics	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Multiparametric MRI in Men With Prostate Cancer Enrolled in Active Surveillance
• Actual Study Start Date: May 1, 2020
• Estimated Primary Completion Date: January 2022
• Estimated Study Completion Date: January 2022

Arms and Interventions

Arm	Intervention/treatment
Enrolled AS patients; Patients with prostate cancer enrolled i active surveillance protocol using PSA, digital rectal examination and conventional TRUS-biopsies	Procedure: multiparametric MRI Diagnostics; Patients with newly diagnosed prostate cancer enrolled in active surveillance following standard protocol including PSA, DRE and TRUS biopsies and intervention with multiparametric MRI + additional biopsies if suspicious lesions are found

Outcome Measures

Primary Outcome Measures :

1. Changes in treatment from active surveillance (observation) to active treatment based on mp-MRI results. [ Time Frame: 12 months ]
   Patients enrolled in active surveillance will progress to active treatment if mp-MRI show previously undetected suspicious areas of significant disease. Significant cancer (measured by Gleason score and cancer core involvement on biopsies) will be confirmed by repeat biopsies of the suspicious areas. The decision to progress to active treatment is based on decision from the treating urologist.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Denmark

Department of Urology, Herlev University Hospital Herlev

Herlev, Denmark, 2730

Sponsors and Collaborators

Herlev Hospital

Investigators

• Principal Investigator: Lars Boesen, MD, PhD; Department of Urology, Herlev University Hospital Herleb, Herlev, Denmark, 2730

More Information

• Responsible Party: Lars Boesen, Primary investigator, MD, PhD, Herlev Hospital
• ClinicalTrials.gov Identifier: NCT03648359
• Other Study ID Numbers: AS
• First Posted: August 27, 2018
• Last Update Posted: November 13, 2020
• Last Verified: November 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lars Boesen, Herlev Hospital:

Prostate biopsy; Prostate cancer; Magnetic resonance imaging; Neoplasm staging

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases