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Laser or freezing: a gentler approach to prostate cancer?

NCT ID NCT02759744

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2017

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 100 years

Sex

Male participants only

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

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