Prostate Cancer
Conditions
Keywords
Focal ablation
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.
Interventions
None listed
Sponsors
University of Texas Southwestern Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (primary setting) | 12 months post treatment | Oncologic outcomes will be assessed by the rate of negative in-field biopsy at 12 months which is defined by the Delphi consensus criterion of absence of clinically significant disease (≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is insignificant) |
| Oncologic outcomes as assessed by the rate of advancement to systemic therapy or radical salvage therapies (primary setting) | 3 years post treatment | Oncologic outcomes will be assessed by the rate of advancement to systemic therapy or radical salvage therapies which is defined by prostatectomy, radiation or hormone therapy. |
| Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (salvage setting) | 12 months post treatment | Oncologic outcomes will be assessed by the rate of negative in-field biopsy at 12 months which is defined by the Delphi consensus criterion of absence of clinically significant disease (≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is insignificant) |
| Oncologic outcomes as assessed by the rate of progression to systemic therapy or radical salvage therapies (salvage setting) | 3 years post treatment | Oncologic outcomes will be assessed by the rate of progression to systemic therapy or radical salvage therapies which is defined by prostatectomy, radiation or hormone therapy. |
| Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (primary setting) | Baseline and 12 months post treatment | Change in urinary function is measured by International Prostate Symptom Score (IPSS) questionnaire which measures urinary symptoms and continence and the scores range from 0 to 35. A change \> 3 points between baseline and follow-up assessments is defined as meaningful for the IPSS. Therefore, increases in IPSS scores larger than 3 points will be categorized as reduced urinary function (worse outcome). |
| Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (salvage setting) | Baseline and 12 months post treatment | Change in urinary function is measured by International Prostate Symptom Score (IPSS) questionnaire which measures urinary symptoms and continence and the scores range from 0 to 35. A change \> 3 points between baseline and follow-up assessments is defined as meaningful for the IPSS. Therefore, increases in IPSS scores larger than 3 points will be categorized as reduced urinary function (worse outcome). |
| Change in erectile function as measured by International Index of Erectile Function (IIEF-5) score questionnaire (primary setting) | Baseline and 12 months post treatment | Change in erectile function is measured by International Index of Erectile Function (IIEF-5) score questionnaire which classifies patients into five severity levels ranging from none (22-25 points) to severe (5-7 points). Patients whose IIEF-5 levels worsen from baseline to follow-up will be categorized as having reduced erectile function. |
| Change in erectile function as measured by International Index of Erectile Function (IIEF-5) score questionnaire (salvage setting) | Baseline and 12 months post treatment | Change in erectile function is measured by International Index of Erectile Function (IIEF-5) score questionnaire which classifies patients into five severity levels ranging from none (22-25 points) to severe (5-7 points). Patients whose IIEF-5 levels worsen from baseline to follow-up will be categorized as having reduced erectile function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events or short-term complications (primary setting) | 30 days post treatment | Adverse events (AE)s will be monitored and evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for 30 days post-treatment |
| Number of participants undergoing combined treatment of the transitional zone (TZ ) due to bladder outlet obstruction caused by Benign prostatic hyperplasia (BPH) | Baseline and 12 months post treatment | Number of participants undergoing combined treatment of the transitional zone (TZ ) due to bladder outlet obstruction caused by BPH will be evaluated to determine efficacy of treatment of the transitional zone in patients with lower urinary tract symptoms (LUTS) due to BPH via International Prostate Symptom Score (IPSS) questionnaire |
| Number of participants with adverse events or short-term complications (salvage setting) | 30 days post treatment | Adverse events (AE)s will be monitored and evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for 30 days post-treatment |
| Number of participants with adverse events or long-term complications (primary setting) | 3 years post-treatment | An adverse event (AE) will be monitored and evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for up to 3 years post-treatment |
| Number of participants with adverse events or long-term complications (salvage setting) | 3 years post-treatment | An adverse event (AE) will be monitored and evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for up to 3 years post-treatment |
Countries
United States
Contacts
CONTACTSonobia Garrett
PRINCIPAL_INVESTIGATORDaniel Segal, M.D.
University of Texas Southwestern Medical Center
Outcome results
None listed