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Multiparametric MRI in Men With Prostate Cancer Enrolled in Active Surveillance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648359
Recruitment Status : Not yet recruiting
First Posted : August 27, 2018
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Lars Boesen, Herlev Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648359


Contacts
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Contact: Lars Boesen, MD, PhD 26171034 lars.boesen@dadlnet.dk

Locations
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Denmark
Department of Urology, Herlev University Hospital Herlev
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
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Principal Investigator: Lars Boesen, MD, PhD Department of Urology, Herlev University Hospital Herleb, Herlev, Denmark, 2730

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Responsible Party: Lars Boesen, Primary investigator, MD, PhD, Herlev Hospital
ClinicalTrials.gov Identifier: NCT03648359    
Other Study ID Numbers: AS
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020

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