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Focal Cryoablation for Intermediate Risk Prostate Cancer

This study is testing a treatment called Focal Cryoablation for men with intermediate risk prostate cancer. This treatment uses very cold temperatures to destroy only the cancerous part of the prostate, leaving more healthy tissue untouched compared to standard treatments. Researchers want to see if this focused approach is effective in controlling prostate cancer and how it impacts your quality of life. You may be eligible if you are an English-speaking adult male with a life expectancy over 10 years and have a specific type of prostate cancer (GG2 or GG3) identified by an MRI fusion biopsy. The main goal is to see how well the treatment prevents cancer from returning in the treated area after 6 months, and to understand your quality of life after the procedure.

Study design
This study is an interventional study planning to enroll 30 participants. It is not specified if it is randomized or blinded.
What's involved
You will receive Focal Cryoablation, have a prostate biopsy, and fill out quality-of-life questionnaires. The questionnaires will be completed for an average of 1 year.
Compensation
Not stated in the trial record.
Follow-up
Your quality of life will be measured for an average of 1 year. The study will also collect information on progression and re-intervention for 5 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05454488

An Evidence-Based Focal Cryotherapy Protocol for Focal Ablation of Intermediate Risk Prostate Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~30 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Focal CryoablationStandard of CareQuality-of-life Questionnaires

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Quality-of-life Questionnaires
Measured over through completion an average of 1 year.

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

Who to contact

Justin Gregg, MD
[email protected]
713-792-3250
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

English-speaking adult males
Life expectancy over 10 years as assessed by treating physician
Prior to enrollment, MRI fusion biopsy of MRI-visible lesion required (as detailed below, which includes systematic biopsy cores)
Single focus GG2 or GG3 (additional GG1 allowed up to 6mm, noting that a single focus of disease is defined as an area seen on MRI that may be biopsied multiple times using targeted biopsies and have systematic core biopsies directly adjacent to targeted cores; all of which being considered as from the same focus)
Histologically confirmed adenocarcinoma of prostate
Organ-confined prostate cancer, clinical stage ≤T2bN0M0
Visible tumor on MRI
No clear evidence or high suspicion of extraprostatic extension or seminal vesical invasion on MRI
Biopsy via transperineal or transrectal approach with at least 2 cores of MRI visible lesions that are PIRADS 2 or higher and 12 core systematic biopsy template (exclusion of cores from systematic template that overlap with targeted cores allowed).
Additional performance of microultrasound guided biopsy is allowed though not required. Please note that every effort will be made to correlate microultrasound findings with MRI, in order to determine if positive results are from the same MRIvisible focus. This determination will be made by the surgeon performing the biopsy.
Note that GGG 1 disease at sites other than ablation zone are allowed provided these are 6mm or less in size. PSA ≤15 ng/mL, or PSAD \<0.15 if PSA \>15 ng/mL
Physician can fully visualize the prostate on transrectal ultrasound on entry biopsy
Lesion anatomically amenable to cryotherapy treatment based on treating physician's discretion
Willing and able to read, understand and sign the study specific informed consent document
Willing and agreeable to comply with study protocol requirements, including focal cryotherapy ablation and all follow up visit requirements
Patients must consent to investigative laboratory protocol (such as, but not limited to, 2021- 0560)

Exclusion

Gleason grade group 4 or 5 disease
Medical history or concurrent disease, which in the opinion of the investigator, poses the patient at significant peri-operative risk of complication due to anesthesia or the procedure
Active urinary tract infection
Any previous treatment for prostate cancer, including radiation therapy, hormonal treatment, biologic therapy for prostate cancer, or chemotherapy
Prior TURP or other prostate outlet procedure such as HoLEP, greenlight, microwave ablation, aquablation, UroLift, or simple prostatectomy.
Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease
Inability to obtain prostate MRI (ex. due to claustrophobia, pacemaker, or prohibitive implants)
Unwilling to consent to laboratory investigative protocol (such as, but not limited to, 2021- 0560)

What this trial measures

  • Quality-of-life Questionnairesthrough completion an average of 1 year.

    Score scale ranges (0-5) 0-Not at all/5- Almost always