Prostate Cancer
Conditions
Keywords
Focal Therapy, High Intensity Frequency Ultrasound, Transurethral Ultrasound Ablation, Cryoablation, Irreversible Electroporation
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.
Interventions
PROCEDUREFocal 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
Sponsors
University of California, San Diego
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
Countries
United States
Contacts
Primary ContactJuan Javier-DesLoges, MD
Outcome results
None listed