NCT06270043

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
94mo left

Started Feb 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Feb 2024Feb 2034

Study Start

First participant enrolled

February 1, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2034

Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

10 years

First QC Date

February 11, 2024

Last Update Submit

February 22, 2024

Conditions

Prostate Cancer

Keywords

Focal TherapyHigh Intensity Frequency UltrasoundTransurethral Ultrasound AblationCryoablationIrreversible Electroporation

Outcome Measures

Primary Outcomes (1)

  • Oncological Response

    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 Outcomes (3)

  • Erectile Dysfunction

    1 year

  • Incontinence

    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.

    10 years

Study Arms (1)

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

Interventions

Focal TherapyPROCEDURE

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

Focal Therapy

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Contraindication to follow-up multi parametric MRI or prostate biopsy
  • Unable to tolerate general or regional anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

La Jolla, California, 92121, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37553435BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Urine and Blood samples will be collected on patients for bio banking and future analysis.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Juan Javier-DesLoges, MD

CONTACT

858-657-8786jjavierdesloges@health.ucsd.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Urology

Study Record Dates

First Submitted

February 11, 2024

First Posted

February 21, 2024

Study Start

February 1, 2024

Primary Completion (Estimated)

February 1, 2034

Study Completion (Estimated)

February 1, 2034

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations

US(1)