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Fusion Guided Focal Laser Ablation of Prostate Cancer

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 6 months later Jan 21, 2027 → Jul 31, 2029
See other at-risk trials from National Institutes of Health Clinical Center (CC)

Record History

The 50 most recent of 142 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jan 21, 2027 to Jul 31, 2029
    • Study completion pushed from Jan 21, 2027 to Jul 31, 2032
    • Eligibility criteria expanded, about 9 words
    • Study description expanded, about 11 words
  2. 10 versions Re-verified since Oct 3, 2025, no change to tracked fieldsv132-v141
  3. Study description expanded, about 11 words
    • Eligibility criteria shortened, about 1 word
    v131
  4. 4 versions Re-verified since May 7, 2025, no change to tracked fieldsv127-v130
  5. Trial status: Suspended to Enrolling by Invitation
    • Enrollment target: 14 to 30
    • Primary and study completion dates: Jan 21, 2026 to Jan 21, 2027
    v126
Show 33 earlier versionsHide 33 earlier versions
  1. 2 versions Re-verified since Mar 11, 2025, no change to tracked fieldsv124-v125
  2. Study Status, Study Description, Eligibilityv123
  3. 6 versions Re-verified since Aug 21, 2024, no change to tracked fieldsv117-v122
  4. Primary completion date: Dec 21, 2024 to Jan 21, 2026
    • Sponsor's reason: This study involves the use of laser fibers but our original manufacturer has discontinued their marketing of product for prostate tissue… to This study involves the use of laser fibers but our original manufacturer has discontinued their marketing of product for prostate tissue
    v116
  5. Primary completion date: Jan 21, 2024 to Dec 21, 2024v115
  6. 3 versions Re-verified since Aug 26, 2023, no change to tracked fieldsv112-v114
  7. Primary completion date: Jan 21, 2023 to Jan 21, 2024v111
  8. Sponsor's reason: This study involves the use of laser fibers but our original manufacturer has discontinued their marketing of product for prostate tissue. to This study involves the use of laser fibers but our original manufacturer has discontinued their marketing of product for prostate tissue…v110
  9. Trial status: Enrolling by Invitation to Suspended Sponsor's reason: This study involves the use of laser fibers but our original manufacturer has discontinued their marketing of product for prostate tissue.
    • Primary completion date: Jan 21, 2025 to Jan 21, 2023
    • Enrollment target: estimated 30 to confirmed 14
    v109
  10. Re-verified, no change to tracked fieldsv108
  11. Primary completion date: Jan 21, 2023 to Jan 21, 2025v107
  12. 14 versions Re-verified since Jun 13, 2022, no change to tracked fieldsv93-v106
  • 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.
Background: Prostate cancer is the most common non-skin cancer in U.S. men. Treatments for early or less aggressive disease are limited. Researchers want to test a device that destroys cancerous tissue with laser energy. They want to see if using it with ultrasound is more comfortable than using it with magnetic resonance imaging (MRI). Objectives: To test a cooled laser applicator system to treat prostate cancer lesions. To see if ultrasound imaging is a practical and feasible treatment with laser ablation for focal prostate cancer treatment. Eligibility: Men at least 18 years old with prostate cancer seen on MRI that has not spread in the body. Design: Participants will be screened with standard cancer care tests. These can include physical exam, lab tests, and MRI. For the MRI, they lie in a machine that takes pictures. Participants will have a prostate biopsy. Needle samples will be taken from 12 places in the prostate. This will be guided by MRI and ultrasound, which is obtained through a coil in the rectum. Participants will stay at the clinic for 1 2 days. A cooling catheter (plastic tube) will be put in the bladder. Ultrasound will guide the laser applicator directly to the tumor. The cooling catheter will be removed. A different catheter will be put in the urethra to keep the bladder emptied. The next day, participants will have a physical exam and a PSA blood test. Participants will have 6 follow-up visits over 3 years. At each visit, they will have a physical exam and lab tests. At some visits, they will also have an MRI or other scans and a prostate biopsy.
Trial Details
NCT Number NCT02759744
Lead Sponsor National Institutes of Health Clinical Center (CC)
Conditions
(from sponsor)		 Prostate Cancer, Prostate Neoplasms
Related terms Prostatic Neoplasms
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov