Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04287088 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

bpMRI and Risk Based Shared Clinical Decision Making in Prostate Cancer Diagnosis

Study acronym: multiIMPROD2
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 23, 2021 (before its estimated December 31, 2021 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Secondary endpoints: 3 to 6v5
  2. Site details revised at 1 of 4 sitesv4
  3. Site details revised at 1 of 4 sitesv3
  4. Secondary endpoints revised (3)
    • Study title expanded, about 7 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The shortcoming of the pre-biopsy prostate MRI approach is the recommendation to biopsy all men post-MRI even if there is no lesion seen in MRI, ie. risk of PCa is very low. Therefore, the primary objective of this trial is to compare if there is a difference between significant cancer detection rate in men undergoing prostate biopsies after MRI scan compared to men undergoing post-MRI prostate biopsies only after a shared decision-making based on prostate cancer risk estimation. The trial will enrol 600 patients. The primary outcome measure is the the proportion of men with CSPCa (Gleason 4+3 prostate cancer or higher) between the control and intervention arms at baseline. Eligible men are randomised 1:1 in two groups. In control arm in all men prostate biopsies are performed after MRI whereas in intervention arm prostate biopsies are performed only after a shared decision-making between urologist and the patient and the discussion is based on risk estimation.
Trial Details
NCT Number NCT04287088
Lead Sponsor Turku University Hospital
Collaborators: Tampere University Hospital, Satakunta Central Hospital, Central Finland Hospital District, Memorial Sloan Kettering Cancer Center, Mount Sinai Hospital, New York
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov