Actively Recruiting
An Evidence-Based Focal Cryotherapy Protocol for Focal Ablation of Intermediate Risk Prostate Cancer
Led by M.D. Anderson Cancer Center · Updated on 2025-11-14
30
Participants Needed
1
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn if using cryotherapy to treat only the part of the prostate known to contain cancer is effective in controlling prostate cancer
CONDITIONS
Official Title
An Evidence-Based Focal Cryotherapy Protocol for Focal Ablation of Intermediate Risk Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English-speaking adult males
- Life expectancy over 10 years as assessed by treating physician
- MRI fusion biopsy confirming single focus Gleason Grade Group 2 or 3 prostate cancer with visible tumor on MRI
- Organ-confined prostate cancer, clinical stage T2bN0M0
- Biopsy includes at least 2 cores of MRI-visible lesions with PIRADS 2 or higher plus 12 core systematic biopsy
- PSA 15 ng/mL, or PSAD <0.15 if PSA >15 ng/mL
- Physician can fully visualize prostate by transrectal ultrasound on biopsy
- Lesion suitable for cryotherapy treatment as determined by physician
- Willing and able to read, understand, and sign informed consent
- Agreeable to comply with study protocol and follow-up requirements
- Consent to investigative laboratory protocol
You will not qualify if you...
- Gleason Grade Group 4 or 5 disease
- Medical conditions posing significant peri-operative risk from anesthesia or procedure
- Active urinary tract infection
- Prior prostate cancer treatments including radiation, hormonal, biologic therapy, or chemotherapy
- Previous prostate outlet procedures such as TURP, HoLEP, greenlight, microwave ablation, aquablation, UroLift, or prostatectomy
- Previous rectal surgery (except hemorrhoidectomy) or rectal disease history
- Unable to undergo prostate MRI (e.g., due to claustrophobia, pacemaker, or implants)
- Unwilling to consent to laboratory investigative protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Justin Gregg, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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