Study on High Intensity Focused Ultrasound for Prostate Cancer

Sponsor: University of Florida

Sponsor score: 60

ClinicalTrials ID:NCT06402357

Provider View

This clinical trial is exploring the effectiveness of using high intensity focused ultrasound (HIFU) to treat localized prostate cancer that has returned after radiation therapy. The study also aims to assess changes in participants' quality of life after receiving HIFU treatment.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well high intensity focused ultrasound (HIFU) works in treating prostate cancer that has come back after radiation therapy. Researchers are also interested in understanding how this treatment affects the quality of life for patients. HIFU is a type of focal therapy that targets specific areas of the prostate, and it is known for having fewer side effects compared to other treatments. This study will focus on patients with significant prostate cancer that has returned in a localized area, as there is limited data on the benefits of focal HIFU in these cases.

Description

Focal therapy, like high intensity focused ultrasound (HIFU), is becoming more popular because it tends to have fewer side effects. HIFU has shown good results in patients with certain types of prostate cancer, especially those at intermediate and high risk. However, there is not much information available about its effectiveness in treating prostate cancer that has returned after radiation therapy. This study will focus on using focal HIFU, which targets specific areas of the prostate, rather than treating the whole gland. The goal is to gather more information on how well this treatment works for men with localized prostate cancer that has come back, particularly in terms of cancer control and maintaining quality of life. The study will include men with clinically significant prostate cancer, defined as grade group 2 or higher, as this type of cancer is more serious and requires treatment.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older who have chosen to undergo high intensity focused ultrasound (HIFU) for prostate cancer that has returned after radiation therapy.
  • Have a history of prostate cancer treated with radiation, with or without hormone therapy.
  • Have a specific area of interest identified by MRI or PSMA PET scan.
  • Have a biopsy confirming significant prostate cancer (grade group 2 or higher) in the area of interest within 6 months of the scan.
  • Have no more than one active cancer at the time of joining the study.
  • Must not have metastatic disease as shown by a PSMA PET scan within 6 months of the biopsy.
  • Must agree to provide written informed consent and follow all study procedures.

Exclusion Criteria

  • Cannot undergo high intensity focused ultrasound due to medical reasons like latex allergy or previous rectal surgery.
  • Have received hormone therapy within 6 months before the study.
  • Have active inflammatory bowel disease treated in the last 3 years.
  • Have evidence of advanced prostate cancer on imaging.
  • Have significant prostate cancer on both sides of the prostate.
  • Have only low-grade prostate cancer at relapse biopsy.
  • Have brachytherapy seeds still implanted.
  • Have markers that interfere with treatment, as determined by the surgeon.
  • Have large calcifications that hinder treatment.
  • Have had active urethral stricture disease in the last 6 months.
  • Have not received prior radiation therapy for prostate cancer.
  • Do not have a specific area of interest on MRI or PET scan.
  • Have metastatic or locally advanced disease.
  • Have any other condition that makes the treatment unsafe or affects study results, as judged by the doctor.
  • Are prisoners or involuntarily detained individuals.

Locations

FACILITYZIPCITYSTATE
University of Florida32608GainesvilleFlorida

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