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

Recruiting now · Phase 2

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT05454488

Run by

M.D. Anderson Cancer Center

People needed

30

Starts

2022-07-25

Expected to finish

2028-01-31

Last updated by the study team

2026-06-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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
• 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)

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)

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.