Focal Therapy for Localized Prostate Cancer
Status
RECRUITING
Phase
Age
≥ 18 Years
Enrollments
500Conditions
Prostate CancerSummary
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.
Locations
1 location Found with status Recruiting
Eligibility 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
Study Plan
Focal Therapy
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 focal therapy as part of their routine prostate cancer treatment, will be invited to participate in this observational registry study.
PROCEDURE:
Focal TherapyDescription:
Focal ablation of prostate cancer using different modalities. These modalities include:nn* Cryoablation or Cryotherapyn* Irreversible Electroporation - Nanoknifen* High Intensity Frequency Ultrasound - FocalOnen* Transurethral Ultrasound Ablation - TULSA - PRO
Outcome Measures
Primary Outcome Measures
Oncological Response
Secondary Outcome Measures
Erectile Dysfunction
Incontinence
Prostate cancer recurrence. Patients will be monitored with a Prostate Specific Antigen (PSA) every 6 months until 10 years from the intervention. Patients with a rising PSA will receive a prostate biopsy to determine if they have a recurrence.
Timeline
Last Updated
February 26, 2024Start Date
February 21, 2024Today
January 23, 2025Completion Date ( Estimated )
February 1, 2034
Sponsors of this trial
Lead Sponsor
University of California, San Diego
RECRUITING 
21 - 64 Years