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Recruiting NCT06270043

Focal Therapy for Localized Prostate Cancer

Observational Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Focal Therapy.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Prospective Registry and Longitudinal Study of Patients Undergoing Focal Therapy for Localized Prostate Cancer

Overview

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.

Interventions

  • Procedure Focal Therapy
    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

Primary outcome measures

  • Oncological Response [Time frame: 1 year]
Secondary outcome measures (3)
  • Erectile Dysfunction [Time frame: 1 year]
  • Incontinence [Time frame: 1 year]
  • 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. [Time frame: 10 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of California, San Diego — La Jolla

Publications

  • Javier-DesLoges J, Dall'Era MA, Brisbane W, Chamie K, Washington SL 3rd, Chandrasekar T, Marks LS, Nguyen H, Daneshvar M, Gin G, Kane CJ, Bagrodia A, Cooperberg MR. The state of focal therapy in the treatment of prostate cancer: the university of California collaborative (UC-Squared) consensus statement. Prostate Cancer Prostatic Dis. 2024 Dec;27(4):579-581. doi: 10.1038/s41391-023-00702-1. Epub 2 PMID 37553435

Identifiers

NCT: NCT06270043 · 809622

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗