Neoadjuvant ADT with TULSA in the Treatment of Intermediate Risk Prostate Cancer

Change in prostate volume after neoadjuvant ADT

Time frame · Baseline and four, eight, and 12 weeks of ADT.

The prostate volume change will be determined by comparing the prostate volume measured on T2-weighted MRI at four, eight, and 12 weeks of ADT to that at baseline.

Change in prostate tumor volume after neoadjuvant ADT

Time frame · Baseline and four, eight, and 12 weeks of ADT.

The prostate tumor volume change will be determined by comparing the prostate tumor volume measured on T2-weighted MRI at four, eight, and 12 weeks of ADT to that at baseline.

The frequency and severity of adverse events

Time frame · Every follow-up visit until the first year of follow-up.

The frequency and severity of adverse events after neoadjuvant Degarelix and TULSA treatment will be determined by using the CTCAE v6.0 classification. Adverse events attributed to TULSA will also be graded using the Clavien Dindo classification for surgical complications.

Change in prostate tumor-capsule contact length after neoadjuvant ADT

Time frame · Baseline and four, eight, and 12 weeks of ADT.

The prostate tumor-capsule contact length change will be determined by comparing the prostate tumor-capsule contact length measured on T2-weighted MRI at four, eight, and 12 weeks of ADT to that at baseline.

Change in prostate vascular perfusion after neoadjuvant ADT

Time frame · Baseline and four, eight, and 12 weeks of ADT.

The change in prostate vascular perfusion will be determined by comparing average blood flow values in the prostate measured on dynamic contrast-enhanced T1-weighted MRI at four, eight, and 12 weeks of ADT to that at baseline.

Change in prostate tumor vascular perfusion after neoadjuvant ADT

Time frame · Baseline and four, eight, and 12 weeks of ADT.

The change in prostate tumor vascular perfusion will be determined by comparing average blood flow values in the prostate tumor measured on dynamic contrast-enhanced T1-weighted MRI at four, eight, and 12 weeks of ADT to that at baseline.

Change in periprostatic, prostate and tumor tissue structures after neoadjuvant ADT

Time frame · Baseline and four, eight, and 12 weeks of ADT.

The change in periprostatic, prostate and tumor tissue structures will be determined by comparing the radiomics features extracted from T2-weighted, T2 relaxation time mapping, and diffusion-weighted images at four, eight, and 12 weeks of ADT to that at baseline.

Thermal coverage after whole-prostate gland TULSA

Time frame · Immediately after the TULSA procedure.

Thermal coverage of the target volume achieved by whole-prostate gland TULSA will be determined by comparing physician-defined target boundaries to MRI measurements of temperature distributions, thermal dose distributions, and acute treatment-induced perfusion defect immediately post-treatment.

Change in quality of life (QoL) and functional status outcomes after neoadjuvant ADT

Time frame · Baseline and 12 weeks of ADT.

The change in QoL and functional status outcomes will be determined by comparing the summary scores of urinary incontinence, urinary irritative/obstructive, bowel, sexual and hormonal domains of the Expanded Prostate Index Composite-26 (EPIC-26) questionnaire at 12 weeks of ADT to that at baseline. EPIC-26 contains 26 items with response options for each EPIC item forming a Likert Scale, and multi-item scale scores transformed linearly to a 0-100 scale, with higher scores representing better functional status/QoL.

Change in lower urinary tract symptoms after neoadjuvant ADT

Time frame · Baseline and 12 weeks of ADT.

The change in lower urinary tract symptoms will be determined by comparing the International Prostate Symptom Score (IPSS) at 12 weeks of ADT to that at baseline. The possible scores for the IPSS questionnaire range from 0 to 35, with higher scores representing worse symptoms.

Change in erectile function after neoadjuvant ADT

Time frame · Baseline and 12 weeks of ADT.

The change in erectile function will be determined by comparing the International Index of Erectile Function (IIEF-5) score at 12 weeks of ADT to that at baseline. The possible scores for the IIEF-5 range from 5 to 25, with higher scores representing a better erectile function.

Change in quality of life (QoL) and functional status outcomes after neoadjuvant ADT and whole-prostate gland TULSA

Time frame · Baseline and 12 weeks of ADT, and three, six, 12, 36 and 60 months after the TULSA procedure.

The change in QoL and functional status outcomes will be determined by comparing the summary scores of urinary incontinence, urinary irritative/obstructive, bowel, sexual and hormonal domains of the Expanded Prostate Index Composite (EPIC-26) questionnaire at three, six, 12, 36 and 60 months post-TULSA to that at baseline and TULSA procedure. EPIC-26 contains 26 items with response options for each EPIC item forming a Likert Scale, and multi-item scale scores transformed linearly to a 0-100 scale, with higher scores representing better functional status/QoL.

Change in lower urinary tract symptoms after neoadjuvant ADT and whole-prostate gland TULSA

Time frame · Baseline and 12 weeks of ADT, and three, six, 12, 36 and 60 months after the TULSA procedure.

The change in lower urinary tract symptoms will be determined by comparing the International Prostate Symptom Score (IPSS) at three, six, 12, 36 and 60 months post-TULSA to that at baseline and TULSA procedure. The possible scores for the IPSS questionnaire range from 0 to 35, with higher scores representing worse symptoms.