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NCT Number: NCT06270043

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University of California, San Diego

La Jolla, California, 92121, United States

Location status: Recruiting

Location contact

Juan Javier-DesLoges, MD

CONTACT

[email protected]

858-657-8786

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Focal therapy

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Javier-DesLoges, MD

CONTACT

[email protected]

858-657-8786

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Feb 21, 2024
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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