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

NCT05454488 | Recruiting Phase 2 DMC

• 2 other identifiers: 2022-0165NCI-2022-05462
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Quality-of-life Questionnaires

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

  through completion an average of 1 year.

Study Arms (1)

Focal therapy Treatment

EXPERIMENTAL

Cryoablation is a procedure in which special needles are inserted into the tumor site.

Drug: Focal Cryoablation; Other: Standard of Care; Other: Quality-of-life Questionnaires

Interventions

Focal Cryoablation DRUG

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

Focal therapy Treatment

Standard of Care OTHER

Participants will receive a prostate biopsy.

Focal therapy Treatment

Quality-of-life Questionnaires OTHER

Participants will fill out questionnaires.

Focal therapy Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Justin Gregg, MD

  jrgregg@mdanderson.org

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin Gregg, MD

CONTACT

713-792-3250; jrgregg@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 12, 2022
• Study Start: July 25, 2022
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (1)