Prostate Cancer Clinical Trial

Outcomes of Focal Ablation for Prostate Cancer

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.

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Full 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.

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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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

225

Study ID:

NCT05478694

Recruitment Status:

Not yet recruiting

Sponsor:

University of Texas Southwestern Medical Center

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There is 1 Location for this study

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UTSW
Dallas Texas, 75390, United States

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

225

Study ID:

NCT05478694

Recruitment Status:

Not yet recruiting

Sponsor:


University of Texas Southwestern Medical Center

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