Menu
Recruiting NCT07203482

Clinical Outcomes in Prostate Cancer Patients Undergoing HIFU Ablation

— 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
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: 40 years — 95 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 →

Unsure about the terms? Read our patient guide →

Official title

A Single-center Observational Study of Clinical Outcomes of Clinically Localized Prostate Cancer Undergoing HIFU Therapy

Overview

Many reports of clinical outcomes following treatment of localized prostate cancer suffer from lack of prospective long-term data using objective and validated outcome instruments. The purpose of this research database is to prospectively collect data to assess treatment related complications, oncologic outcomes and urinary/sexual function, and identify predictors of complications, oncological control and functional outcomes after Hhigh-intensity focused ultrasound (HIFU) ablation of prostate cancer with the intent to guide further research and improve patient care. We will include subjects who will have a HIFU procedure performed from all Sub-Investigators included in the study.

Primary outcome measures

  • Change in Prostate-Specific Antigen (PSA) Levels [Time frame: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60]
  • Change in Urinary Function Score [Time frame: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60]
  • Change in Urinary Continence Score [Time frame: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60]
  • Change in Sexual Function Score [Time frame: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60]
  • Change in Ejaculatory Function Score [Time frame: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60]
  • Change in Sexual Health Inventory for Men (SHIM) Score [Time frame: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60]
  • Decision Regret Score [Time frame: Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60]
  • Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment Imaging [Time frame: Up to Month 60]
  • Number of Participants with New Lesions in the Non-Treated Prostate on Post-Treatment Imaging [Time frame: Up to Month 60]
  • Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment Prostate Biopsy [Time frame: Up to Month 60]

Eligibility criteria

Inclusion criteria

  • Males, ages 40-95
  • Evidence of focal prostate cancer confined to the prostate based on MRI imaging and prostate biopsy
  • Patients with clinically localized prostate cancer (no evidence for or concern for metastatic spread of cancer outside of the prostate) that select focal HIFU prostate ablation as their treatment option will be offered inclusion into this prospective data collection research database.
  • Patients who have early (Gleason 6 or 7), low grade cancer that is confined to the prostate.
  • Willing and able to provide consent.

Exclusion criteria

  • Patients that are not diagnosed with prostate cancer.
  • Patients that are diagnosed with clinically localized prostate cancer, but select other tratment options as their desired treatment.
  • Patients that are not willing or are not able to give consent.

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

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • NYU Langone Health - Cobble Hill — Brooklyn
  • NYU Langone Health - Tisch Hospital — New York

Identifiers

NCT: NCT07203482 · 23-01458

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗