Laser or freezing: a gentler approach to prostate cancer?
NCT ID NCT02759744
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 3 times
Summary
This pilot study is testing a device that uses ultrasound images to guide a laser or freezing probe directly into prostate tumors. The goal is to destroy only the cancerous tissue while sparing healthy areas. Thirty men with low- to intermediate-risk prostate cancer that hasn't spread will be treated and followed for three years to see if the approach is safe and practical.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- laser ablation or cryotherapy device
- What this could lead to
- If successful, this could offer a less invasive, outpatient-like treatment for low-risk prostate cancer, potentially reducing side effects compared to surgery or radiation.
- What could go wrong
- This is a very small pilot study (30 men) focused on feasibility, not effectiveness. The treatment may not fully destroy the tumor, and long-term outcomes are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2017
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * Enrollment open only to current NIH patients enrolled in 16-C-0010. * Patients Patients must have clinically localized, non-aggressive, favorable or unfavorable, low to intermediate risk prostate cancer as defined per current NCCN guidelines (i.e, including review and determination of pathology and tumor characteristics, Gleason Score, PSA levels, and other assessments as clinically appropriate).Organ confined clinical prostate cancer that is US-targetable and/ or visualized on MRI or by a semi-automated software tool * Prostate cancer diagnosed by transrectal or transperineal US-guided standard 12 core needle biopsy, MR image-guided needle biopsy, or MR/US fusion-guided needle biopsies or biopsies performed under semi-automated tools. * Targeted tumors must be considered a safe distance (\>= 8 mm) from the urethra, rectal wall, bladder wall or neurovascular bundle by the Principal Investigator. * Must have had a prostate MRI performed at the NIH within 12 months prior to enrollment. * Must have had a prostate biopsy performed at NIH within 12 months (+2 months) prior to enrollment. * Men \>18 years of age. * ECOG performance status \<=2. * Patients must have adequate organ and marrow function as defined below: * leukocytes: \>=3,000/mcL * absolute neutrophil count: \>=1,500/mcL * platelets: \>=75,000/mcL * creatinine: within normal institutional limits OR --creatinine clearance: \>=60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. * Preoperative clearance by NIH Department of Anesthesia and Surgical Services * Ability of subject to understand and the willingness to sign a written informed consent document. * Subject understands that this is an experimental protocol and that there are available standard treatment options. These options would include but not be limited to: active surveillance, external beam radiation and brachytherapy, androgen deprivation therapy, or prostatectomy. EXCLUSION CRITERIA: * Patient unable to commit to follow-up * Acute urinary tract infection * Patients with uncontrolled coagulopathies * Altered mental status preventing consent or answering questions during conduct of the trial will be excluded for safety purposes * A serious acute or chronic illness that is determined by the PI to place the patient at unreasonable risk for anesthesia and the procedure. * Inability to undergo a contrast enhanced MRI per American College of Radiology and the Clinical Center, Department of Radiology guidelines. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the Principal Investigator, would limit compliance with study requirements.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?