Outcomes of Focal Ablation for Prostate Cancer

The University of Texas System (UT)

Status and phase

Enrolling

Phase 2

Conditions

Prostate Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT05478694

STU-2022-0641

Details and patient eligibility

About

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.

Full description

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.

Enrollment

225 estimated patients

Sex

Male

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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