Ablative Therapy in the Management of Prostate Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Weill Medical College of Cornell University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Prostate biopsy Gleason grade
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
The purpose of this study is collect observational data regarding patterns of care and outcomes of focal therapies for prostate cancer, including but not limited to: high-intensity focused ultrasound (HIFU), cryotherapy, focal laser ablation, irreversible electroporation, photodynamic therapy, and brachytherapy.
Detailed Description
Through the use of a pro- and retrospective registry, the investigators will collect information on patient characteristics including age, co-morbidities, imaging and biopsy information, and prior treatments. Information on treatment details will also be captured, including treatment time, anesthesia delivered, and length of stay, when applicable. Oncologic outcomes including PSA, post-treatment biopsy and imaging data, need for re-treatment, and survival outcomes will also be captured. Safety outcomes will be captured using the Clavien-Dindo classification scale, and additional specific GU complications will be recorded, which include urinary retention, urethral stricture, recto-urethral fistula, osteomyelitis, and urinary tract infection. Finally, the investigators will capture functional outcomes using health related quality of life questionnaires including the EPIC questionnaire, IIEF-5, MSHQ-EjD, and IPSS.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\>18 years of age
- •Undergoing focal therapy for primary or salvage treatment of prostate cancer, or
- •Have received prior focal therapy
Exclusion Criteria
- •Clinically-evident metastatic disease
- •Unable to fill out an English-language questionnaire
Outcomes
Primary Outcomes
Prostate biopsy Gleason grade
Time Frame: 12 months
Will be obtained through patient biopsy pathology results
Secondary Outcomes
- Patient characteristics/demographics(12 months)
- MRI PI-RAD grade(12 months)
- Lab results - PSA level(12 months)
- Patient-reported quality of life: MSHQ-EjD(12 months)
- Patient-reported quality of life: EPIC-26(12 months)
- Patient-reported quality of life: IIEF-5(12 months)
- Patient-reported quality of life: IPSS(12 months)