Focal Therapy for Localized Prostate Cancer

NCT ID: NCT06270043

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2034-02-01

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Focal Therapy

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Juan Javier-DesLoges

Assistant Professor of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, San Diego

La Jolla, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Juan Javier-DesLoges, MD

Role: CONTACT

858-657-8786

Facility Contacts

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Juan Javier-DesLoges, MD

Role: primary

858-657-8786

References

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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 2023 Aug 8. No abstract available.

Reference Type BACKGROUND
PMID: 37553435 (View on PubMed)

Other Identifiers

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809622

Identifier Type: -

Identifier Source: org_study_id

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