Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURECryosurgery
Undergo focal cryotherapy ablation
Undergo high intensity frequency ultrasound ablation
OTHERSurvey Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Marc Dall'Era, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to understand and willingness to sign an informed consent form * Clinically localized grade group 1, 2, or 3 prostate cancer and unilateral magnetic resonance imaging (MRI) visible lesion(s). Up to 3 lesions will be allowed for focal treatment * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥ 70%) * Patients ≥ 18 years of age at time of consent * Life expectancy ≥ 5 years * Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study
Exclusion criteria
* Nodal or distant metastases * Prior treatment for prostate cancer * Anticipated treatment with any cancer intervention, including radiation, hormonal therapy or surgery ≤ 6 months prior to focal therapy in this study * Known contraindications to general anesthesia * Uncorrectable coagulopathy * Significant active cardiac disease within the previous 6 months including: New York Heart Association (NYHA) class 4 congestive heart failure (CHF), unstable angina, or myocardial infarction * Any condition that would prohibit the understanding or rendering of informed consent * Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic outcome on surveillance prostate biopsy | At year 1 and 3 | 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. |
| Proportion of participants who go onto whole gland salvage treatment | At 3 years | Will be estimated using the Kaplan-Meier method. |
| Salvage whole gland treatment free survival | At 3 years | Will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable Cox proportional hazards models. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary function | At 1 year | Scores from Expanded Prostate Cancer Index Composite (EPIC-26) prostate cancer questionnaire will be used to assess urinary function. |
| Adverse events | Up to end of treatment visit, approximately 7-14 days after treatment | Number of participants experiencing treatment-related AEs, classified by severity and grade. |
| Sexual function | At 1 year | Scores from EPIC-26 prostate cancer questionnaire will be used to assess sexual function. |
| Quality of life | At 1 year | Scores from EPIC-26 prostate cancer questionnaire will be used to assess quality of life. |
Countries
United States
Outcome results
None listed