Recruiting
Phase 2

Cryotherapy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05454488

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Focal Cryoablation

Standard of Care

Quality-of-life Questionnaires

Study Details

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

Study ID

NCT05454488

Start date

Jul 25, 2022

Status verified date

May, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Focal therapy Treatment

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

Interventions

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

Standard of Care

Participants will receive a prostate biopsy.

Quality-of-life Questionnaires

Participants will fill out questionnaires.

Primary outcome measure

  • Quality-of-life Questionnaires [ Time Frame: through completion an average of 1 year. ]

Central Contacts and Locations

Central contacts

Justin Gregg, MD

713-792-3250jrgregg@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Justin Gregg, MD

713-792-3250jrgregg@mdanderson.org

Principal Investigator:

Justin Gregg, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-06-02.