Clinical trial NCT05478694: Outcomes of Focal Ablation for Prostate Cancer
Official title: Prospective Single Institutional Study Evaluating the Outcomes for Patients Undergoing Ablative Therapies in the Management of Clinically Localized Prostate Cancer in the Primary and Salvage Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: Focal ablation
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 225
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with prostate cancer

Brief summary: This study will be designed to define the efficacy and safety of ablative therapies in the management of localized prostate cancer and comprehensively evaluate quality of life outcomes and oncologic control following treatment.

Detailed description: This study will be designed to define the efficacy and safety of ablative therapies in the management of localized prostate cancer and comprehensively evaluate quality of life outcomes and oncologic control following treatment.

There are several commercially available standard of care treatments available for local therapy of the prostate. Ablative therapies may be delivered via a whole gland or focal approach by systems including cryoablation (CA), brachytherapy, irreversible electroporation (IRE), high intensity focused ultrasound (HIFU), MRI-guided transurethral ultrasound ablation (TULSA) procedure or future novel prostate ablation systems.

These are single, outpatient treatments lasting between 2-4 hours and include treatment planning and energy delivery under guidance and are either administered via transperineally approach (cryoablation, IRE, brachytherapy) or via the urethral (TULSA-Pro) or rectum (HIFU).

This study protocol will not include experimental therapy and the enrolled subjects will undergo the ablative therapy as part of their standard of care treatment.

Eligibility criteria: Inclusion Criteria:

* Men with histologically confirmed prostate adenocarcinoma diagnosed on prostate biopsy
* Men with histologically confirmed local recurrence of prostate cancer diagnosed on prostate biopsy and standard of care imaging excluding locoregional or metastatic disease
* Age 18-90 years.
* Life expectancy \> 1 year
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Anatomic abnormalities that do not allow for focal ablation
* Evidence of non-organ confined disease that is not feasible for ablation
* Has active urinary traction infection

Primary outcomes:
measure: Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (primary setting)
timeFrame: 12 months post treatment
measure: Oncologic outcomes as assessed by the rate of advancement to systemic therapy or radical salvage therapies (primary setting)
timeFrame: 3 years post treatment
measure: Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (salvage setting)
timeFrame: 12 months post treatment
measure: Oncologic outcomes as assessed by the rate of progression to systemic therapy or radical salvage therapies (salvage setting)
timeFrame: 3 years post treatment
measure: Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (primary setting)
timeFrame: Baseline and 12 months post treatment
measure: Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (salvage setting)
timeFrame: Baseline and 12 months post treatment
measure: Change in erectile function as measured by International Index of Erectile Function (IIEF-5) score questionnaire (primary setting)
timeFrame: Baseline and 12 months post treatment
measure: Change in erectile function as measured by International Index of Erectile Function (IIEF-5) score questionnaire (salvage setting)
timeFrame: Baseline and 12 months post treatment
Secondary outcomes:
measure: Number of participants with adverse events or short-term complications (primary setting)
timeFrame: 30 days post treatment
measure: Number of participants undergoing combined treatment of the transitional zone (TZ ) due to bladder outlet obstruction caused by Benign prostatic hyperplasia (BPH)
timeFrame: Baseline and 12 months post treatment
measure: Number of participants with adverse events or short-term complications (salvage setting)
timeFrame: 30 days post treatment
measure: Number of participants with adverse events or long-term complications (primary setting)
timeFrame: 3 years post-treatment
measure: Number of participants with adverse events or long-term complications (salvage setting)
timeFrame: 3 years post-treatment
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UTSW
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Xiaosong Meng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: