Prostate Adenocarcinoma, Prostate Cancer, Prostate Disease
Conditions
Keywords
prostate cancer, cryoablation
Brief summary
This is a prospective data collection of men who are electing to undergo prostate hemi-gland cryoablation. The purpose of this observational research study is to investigate the localized treatment of prostate cancer using hemi-gland cryoablation. UCLA patients undergoing hemi-gland cryoablation are a unique cohort compared to prior research because all patients at UCLA have had a pre-treatment multi-parametric MRI and Ultrasound fusion targeted biopsy; they will be followed in a similar fashion. This results in more precise assessment of a target region of cancer for ablation which may, in turn, result in improved clinical outcomes.
Interventions
DEVICEHemigland Cryoablation
Hemigland cryoablation for the treatment of prostate cancer
Sponsors
Jonsson Comprehensive Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Patient has undergone or has elected to undergo hemi-gland cryoablation at UCLA * Low or intermediate risk prostate cancer (Gleason ≤ 7) or select high-risk patients (Gleason 8 prostate cancer). * Prostate volume of ≤ 70 cc * Ability to complete informed consent form
Exclusion criteria
* Medical contraindication to follow-up multi-parametric magnetic resonance imaging (mpMRI) or prostate biopsy * Patients unable to tolerate general or regional anesthesia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response to Cancer Treatment | 6 months | Our primary endpoint will be a patient's clinical response to cancer treatment, specifically, the degree of prostate cancer on a post-treatment fusion biopsy compared to pre-treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Assessment - Urinary Function | 6 months | Comparison of urinary function pre- and post-treatment will be obtained using the International Prostate Symptom Score (IPSS) and the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaires to report combined overall urinary function assessments. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLeonard S Marks, MD
University of California, Los Angeles
Outcome results
None listed