Evaluating focal ablation treatments for prostate cancer
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
This study is testing different types of heat and cold treatments for men with localized prostate cancer to see how well they work and how they affect quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 225 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05478694 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of various ablative therapies for localized prostate cancer, including cryoablation, brachytherapy, irreversible electroporation, high intensity focused ultrasound, and MRI-guided transurethral ultrasound ablation. The study will also evaluate quality of life outcomes and oncologic control following these treatments. Participants will receive standard of care ablative therapy in an outpatient setting, with treatments lasting between 2-4 hours. The study will focus on men diagnosed with prostate adenocarcinoma and local recurrence, ensuring a comprehensive understanding of treatment impacts.
Who should consider this trial
Good fit: Ideal candidates include men aged 18-90 with histologically confirmed localized prostate adenocarcinoma or local recurrence, who are eligible for standard ablative therapies.
Not a fit: Patients with non-organ confined disease, active urinary tract infections, or anatomical abnormalities preventing focal ablation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective management strategies for localized prostate cancer, potentially improving patient outcomes and quality of life.
How similar studies have performed: Previous studies have shown promising results with various ablative therapies for prostate cancer, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- Utsw — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Segal, M.D. — University of Texas Southwestern Medical Center
- Study coordinator: Sonobia Garrett
- Email: Sonobia.Garrett@UTSouthwestern.edu
- Phone: 214/645-8482
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.