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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-09811 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| UCDCC306 | Other Identifier | University of California Davis Comprehensive Cancer Center | |
| P30CA093373 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial evaluates the effectiveness of focal ablation with either focal cryotherapy or high intensity frequency ultrasound for the treatment of men with localized prostate cancer. Focal cryotherapy kills tumor cells by freezing them. High intensity frequency ultrasound uses highly focused ultrasound waves to produce heat and destroy tumor cells.
PRIMARY OBJECTIVE:
I. To determine the efficacy of focal therapy for treatment of prostate cancer.
SECONDARY OBJECTIVES:
I. Patient reported urinary, sexual function and quality of life (QOL) at 1 year.
II. To assess safety.
OUTLINE:
Patients undergo focal cryotherapy or high intensity focused ultrasound on study.
After completion of study treatment, patients are followed up at 7-14 days and periodically for up to 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (cryosurgery, high intensity focused ultrasound) | Experimental | Patients undergo focal cryotherapy or high intensity focused ultrasound on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryosurgery | Procedure | Undergo focal cryotherapy ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic outcome on surveillance prostate biopsy | Confidence intervals for the pathologic response rate will be calculated using the Wilson score method. Pathologic response rate will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable logistic regression. | At year 1 and 3 |
| Proportion of participants who go onto whole gland salvage treatment | Will be estimated using the Kaplan-Meier method. | At 3 years |
| Salvage whole gland treatment free survival | Will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable Cox proportional hazards models. | At 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary function | Scores from Expanded Prostate Cancer Index Composite (EPIC-26) prostate cancer questionnaire will be used to assess urinary function. | At 1 year |
| Sexual function | Scores from EPIC-26 prostate cancer questionnaire will be used to assess sexual function. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Office of Clinical Research | Contact | 916-382-6970 | OCRReferral@health.ucdavis.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marc Dall'Era | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Comprehensive Cancer Center | Recruiting | Sacramento | California | 95817 | United States |
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| High-Intensity Focused Ultrasound Ablation | Procedure | Undergo high intensity frequency ultrasound ablation |
|
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| Survey Administration | Other | Ancillary studies |
|
| At 1 year |
| Quality of life | Scores from EPIC-26 prostate cancer questionnaire will be used to assess quality of life. | At 1 year |
| Adverse events | Number of participants experiencing treatment-related AEs, classified by severity and grade. | Up to end of treatment visit, approximately 7-14 days after treatment |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| D057086 | High-Intensity Focused Ultrasound Ablation |
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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