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

To learn if using cryotherapy to treat only the part of the prostate known to contain cancer is effective in controlling prostate cancer

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Standard of Care; Other: Quality-of-life Questionnaires; Drug: Focal Cryoablation

Detailed Description

Primary Objective:

• To determine the effectiveness of an evidence-based focal cryotherapy ablation by measuring negative in-field recurrence rate at 6-months post-ablation.

Secondary Objectives:

• To determine quality of life following focal prostate cancer ablation using validated questionnaires (EPIC-26, AUA symptoms score, SHIM).
• To establish PSA kinetics post-evidence-based focal cryotherapy ablation.
• To determine rates of out of field recurrence on 6-month biopsy following focal cryotherapy ablation.
• To determine MRI findings post-focal cryotherapy ablation, including those related to prostate and surrounding periprostatic fat volume.
• To determine rate of progression and re-intervention collected as part of standard of care treatment for 5-year following study treatment.
• To describe financial toxicity associated with focal prostate cancer treatment using cryotherapy.
• To describe the incidence and severity of complications within 30-days after the study focal ablation treatment.
• To describe imaging findings on PSMA PET MRI performed in a subset of men after standard of care focal cryotherapy prior to 6-month biopsy.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Justin Gregg, MD; Phone Number: 713-792-3250; Email: jrgregg@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Md Anderson Cancer Center
      • Contact: Justin Gregg, MD; Phone Number: 713-792-3250; Email: jrgregg@mdanderson.org
      • Principal Investigator: Justin Gregg, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• 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 criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Focal therapy Treatment; Cryoablation is a procedure in which special needles are inserted into the tumor site.	Other: Standard of Care; Participants will receive a prostate biopsy.; Other: Quality-of-life Questionnaires; Participants will fill out questionnaires.; Drug: Focal Cryoablation; Participants will have the Focal cryoablation placed by the needles in such a way that the area of affected tissue is much smaller and focus just on the tumor tissue and surrounding area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality-of-life Questionnaires	Score scale ranges (0-5) 0-Not at all/5- Almost always	through completion an average of 1 year.

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: Philanthropic Sources
• Investigators: Principal Investigator: Justin Gregg, MD, jrgregg@mdanderson.org

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2022-0165 (UW Madison); NCI-2022-05462 (Other Identifier: NCI-CTRP Clinical Trials Reporting Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No