The purpose of this research is to gather information on the safety and effectiveness of combining focal prostate ablation therapy ((aka Focal Therapy, a surgical procedure) and androgen deprivation therapy (hormone therapy).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
ADT will be given for 3 months. Participants will receive a standard ADT as chosen by their study doctor.
Focal prostate ablation (focal therapy) is a surgical procedure to destroy cancer cells by destroying a portion of the prostate instead of the whole prostate.
UChicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States
RECRUITINGNumber of participants with clinically significant residual prostate cancer in ablated prostate tissue following study treatment
Proportion of participants that have residual cancer in ablated prostate tissue. Residual disease will be measured by MRI.
Time frame: End of Treatment (approximately 4-5 months)
Number of participants with clinically significant residual prostate cancer in unablated prostate tissue following study treatment
Proportion of participants that have residual cancer in unablated prostate tissue. Residual disease will be measured by MRI.
Time frame: End of Treatment (approximately 4-5 months)
Number and grade of complications [Safety]
Number and grade of complications will be reported. Number and grade of complications will be reported. The number and severity by Common Terminology Criteria for Adverse Events (CTCAE) grade of reported complications will be reported.
Time frame: 6-months following treatment
Measuring change in genitourinary and sexual function and health-related quality of life (measured by HRQoL)
Define change in genitourinary and sexual function from baseline following ADT and FT by measuring the subject's HRQoL
Time frame: 6-and 12-months after FT
PSA response to the combination treatment
Determine the PSA response to the combination treatment by measuring the subject's PSA at "baseline" (PSA at time of initial diagnosis) 3-months, 6-months, and 1-year from FT
Time frame: Baseline, 3-months, 6-months, and 1-year from FT
Proportion of men converting therapy or dying of prostate cancer during study
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Determine the proportion of men converting to whole gland therapy (radical prostatectomy or radiation therapy) and/or requiring systemic therapy and/or developing metastases and/or dying of PCa during the course of study.
Time frame: 12 months after FT
Post Treatment biopsy with no prostate cancer
Determine the proportion of men without any prostate cancer on any post treatment prostate biopsy.
Time frame: 6 months after FT
Proportion of men with normal baseline serum
Determine the proportion of men with normal baseline serum testosterone who had testosterone recovery (defined as testosterone levels \>300 ng/dL) at 6-, 9- and 12-months after FT. Testosterone recovery: Number of men who have recovered normal serum testosterone levels will be expressed as proportions of total number of eugonadal patients and the 95% confidence interval of the proportion will be presented.
Time frame: 6-, 9- and 12-months after FT.