Study on Using Cryotherapy to Target and Treat Intermediate Risk Prostate Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05454488

Provider View

This clinical trial is exploring whether using cryotherapy to freeze and treat only the cancerous part of the prostate is effective in controlling prostate cancer.

Patient Parameters

Program Overview

The aim of this study is to find out if using cryotherapy to specifically target and treat the cancerous area of the prostate can effectively control prostate cancer. Cryotherapy involves freezing the cancer cells to destroy them, and this study will measure how well this method works in preventing the cancer from returning in the treated area six months after the procedure.

Description

The main goal of this study is to see if cryotherapy can effectively treat prostate cancer by measuring the rate of cancer recurrence in the treated area six months after the procedure.

Other goals include:

  • Assessing the quality of life after treatment using specific questionnaires.
  • Monitoring changes in PSA levels, a marker used to track prostate cancer.
  • Checking for cancer recurrence outside the treated area through a biopsy six months after treatment.
  • Evaluating MRI results after treatment to see changes in the prostate and surrounding areas.
  • Tracking the progression of the disease and any additional treatments needed over five years.
  • Understanding the financial impact of cryotherapy treatment.
  • Recording any complications within 30 days after treatment.
  • Analyzing imaging results from a specific type of MRI scan in some patients after treatment and before the six-month biopsy.

Eligibility Criteria

Inclusion Criteria

  • English-speaking men who are adults.
  • Have a life expectancy of more than 10 years.
  • Must have had an MRI-guided biopsy of the prostate lesion before joining the study.
  • Have a single focus of intermediate risk prostate cancer (GG2 or GG3) with some low-risk areas allowed.
  • Cancer must be confined to the prostate and visible on an MRI scan.
  • No signs of cancer spreading beyond the prostate on MRI.
  • Biopsy must show at least two samples from the cancerous area and a systematic biopsy of the prostate.
  • The prostate must be visible on ultrasound during the biopsy.
  • The cancerous area must be suitable for cryotherapy treatment.
  • Must be willing to read and sign the consent form and follow the study requirements, including the cryotherapy treatment and follow-up visits.
  • Must agree to participate in additional laboratory studies related to the trial.

Exclusion Criteria

  • Have high-risk prostate cancer (Gleason grade group 4 or 5).
  • Have medical conditions that increase the risk of complications from anesthesia or the procedure.
  • Have an active urinary tract infection.
  • Have had any previous treatment for prostate cancer, such as radiation or hormone therapy.
  • Have had certain prostate surgeries or procedures.
  • Have had previous rectal surgery or have a history of rectal disease.
  • Cannot have an MRI due to medical reasons like claustrophobia or having a pacemaker.
  • Unwilling to participate in additional laboratory studies related to the trial.

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