Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focal Therapy | Procedure | Focal ablation of prostate cancer using different modalities. These modalities include:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Male
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Javier-DesLoges, MD | Contact | 858-657-8786 | jjavierdesloges@health.ucsd.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | Recruiting | La Jolla | California | 92121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37553435 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Urine and Blood samples will be collected on patients for bio banking and future analysis.
|
| 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 |
| 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |