Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06517901 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

Study acronym: FOCUS-PC
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 1, 2024 to Apr 18, 2025
    • Study sites: 1 to 4
    v5
  2. Start date: Oct 15, 2024 to Nov 1, 2024v4
  3. Start date: Aug 15, 2024 to Oct 15, 2024v3 Show 6 more changesShow less
    • Enrollment target: 1312 to 1306
    • Study sites: 0 to 1
    • Primary completion date: Jul 15, 2026 to Dec 31, 2026
    • Study completion date: Dec 30, 2026 to Jun 30, 2027
    • Eligibility criteria expanded, about 42 words
    • Study description expanded, about 32 words
  4. Enrollment target: 1250 to 1312
    • Eligibility criteria shortened, about 1 word
    • Study description shortened, about 2 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 MRI-targeted biopsy for prostate cancer detection can be performed using one of two techniques: 1. Software-based fusion of MRI and ultrasound images (software fusion) or 2. Visually estimated MRI-informed (cognitive fusion) technique To date, there is a lack of adequately powered RCTs directly comparing the cognitive vs fusion targeted biopsy. This randomized study will directly compare the detection rates of clinically significant prostate cancer following either the cognitive or the fusion targeted prostate biopsy in men with suspicious lesions noted on multi-parametric MRI (mp-MRI) of prostate.
Trial Details
NCT Number NCT06517901
Lead Sponsor Albany Medical College
Conditions
(from sponsor)		 Prostate Cancer, Diagnosis
Related terms Disease, Neoplasms, Prostatic Neoplasms
Enrollment 1,306 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov