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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemigland Cryoablation | Device | Hemigland cryoablation for the treatment of prostate cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response to Cancer Treatment | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Assessment - Urinary Function | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Assessment - Erectile Function | Comparison of erectile function pre- and post-treatment will be obtained using the 5-Item International Index of Erectile Function (IIEF-5) Sexual Health Inventory for Men and the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaires to report combined overall erectile function assessments. | 6 months |
Inclusion Criteria:
Exclusion criteria:
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Patients who are candidates for hemi-gland cryoablation, and elect this treatment option as a standard of care procedure, will be considered for our clinical study and analysis of their outcomes. Subjects will provide informed consent to participate in this study during standard of care clinical visits at the Clark Urology Center at UCLA. Subjects will provide informed consent to allow study staff to abstract data from their medical records.
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| Name | Affiliation | Role |
|---|---|---|
| Leonard S Marks, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40961406 | Derived | Weiner AB, Proudfoot JA, Aker M, Cardenas M, Gonzalez S, Kelly E, Davicioni E, Sisk AE Jr, Brisbane WG, Marks LS. Genomic Biomarker for Prostate Cancer Focal Therapy: Post Hoc Assessment of a Phase II Clinical Trial. JCO Precis Oncol. 2025 Sep;9:e2500535. doi: 10.1200/PO-25-00535. Epub 2025 Sep 17. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011469 | Prostatic Diseases |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |