Focal Therapy for Localized Prostate Cancer

Recruiting

• Conditions: Prostate Cancer
• Interventions: Procedure: Focal Therapy

• Registration Number: NCT06270043
• Lead Sponsor: University of California, San Diego

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.

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 Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-01
• Study First Submitted: 2024-02-11
• Study First Submitted QC: 2024-02-19
• Study First Posted: 2024-02-21
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-26
• Primary Completion: 2034-02-01
• Study Completion: 2034-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Focal Therapy	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.

Primary Outcome Measures

Name	Time	Method
Oncological Response	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 Outcome Measures

Name	Time	Method
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	Assess long-term recurrence risk after ablation
Incontinence	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.
Erectile Dysfunction	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.

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States