Focal Therapy for Localized Prostate Cancer

February 22, 2024 updated by: Juan Javier-DesLoges, University of California, San Diego

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oncological Response
Time Frame: 1 year

The following definitions will be used for evaluation of oncological response:

Complete response: Ablation of prostate tissue in targeted biopsy cores at 12 months.

Incomplete response: Residual disease at 12 months compared to baseline in target biopsy cores or systematic biopsy cores.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erectile Dysfunction
Time Frame: 1 year

Assess impact on erections after ablation. The Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire will be used to evaluate sexual health quality-of-life symptoms for participants pre- and post-ablation.

Patients will receive a score between 0 and 12, 0 being low with a better outcome and 12 being high with a worse outcome.
1 year
Incontinence
Time Frame: 1 year

Assess impact on continence after ablation. The Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire will be used to evaluate urinary health quality-of-life symptoms for participants pre- and post-ablation.

Patients will receive a score between 0 and 12, 0 being low with a better outcome and 12 being high with a worse outcome.
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
Assess long-term recurrence risk after ablation
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

February 1, 2034

Study Completion (Estimated)

February 1, 2034

Study Registration Dates

First Submitted

February 11, 2024

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 809622

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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