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Trial Title:
Focal Therapy for Localized Prostate Cancer
NCT ID:
NCT06270043
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Focal Therapy
High Intensity Frequency Ultrasound
Transurethral Ultrasound Ablation
Cryoablation
Irreversible Electroporation
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Focal Therapy
Description:
Focal ablation of prostate cancer using different modalities. These modalities include:
- Cryoablation or Cryotherapy
- Irreversible Electroporation - Nanoknife
- High Intensity Frequency Ultrasound - FocalOne
- Transurethral Ultrasound Ablation - TULSA - PRO
Arm group label:
Focal Therapy
Summary:
This prospective registry and longitudinal study that is designed to carefully measure
details of prostate cancer patients' outcomes with focal therapy. The goal of which is to
improve patient care.
Detailed description:
This observational study will serve to collect data from medical record and review
questionnaires before and after focal ablation of prostate tissue. All enrolled subjects
will have already undergone or scheduled to receive the focal therapy as part of their
prostate cancer treatment.
Criteria for eligibility:
Study pop:
Subjects who have biopsy-proven adenocarcinoma of the prostate, who have met all study
inclusion and exclusion criteria, and have elected to receive or have already received
the focal therapy as part of their routine prostate cancer treatment, will be invited to
participate in this observational registry study.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Subject has elected or already undergone focal therapy as their standard of care
treatment method and declined alternative treatment (active surveillance, radical
prostatectomy, and radiation therapy)
- PSA ≤ 20
- Ability to complete informed consent form
Exclusion Criteria:
- Contraindication to follow-up multi parametric MRI or prostate biopsy
- Unable to tolerate general or regional anesthesia
Gender:
Male
Gender based:
Yes
Gender description:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of California, San Diego
Address:
City:
La Jolla
Zip:
92121
Country:
United States
Status:
Recruiting
Contact:
Last name:
Juan Javier-DesLoges, MD
Phone:
858-657-8786
Email:
jjavierdesloges@health.ucsd.edu
Start date:
February 1, 2024
Completion date:
February 1, 2034
Lead sponsor:
Agency:
University of California, San Diego
Agency class:
Other
Source:
University of California, San Diego
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06270043
