Focal Therapy for Localized Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06270043
• Other study ID #: 809622
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: February 1, 2034

Study information

• Verified date: February 2024
• Source: University of California, San Diego
• Contact: Juan Javier-DesLoges, MD
• Phone: 858-657-8786
• Email: jjavierdesloges[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 1, 2034
• Est. primary completion date: February 1, 2034
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & 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. 2023 Aug 8. doi: 10.1038/s41391-023-00702-1. Online ahead of print. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Erectile Dysfunction	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
Secondary	Incontinence	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
Secondary	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.	Assess long-term recurrence risk after ablation	10 years