Ablative Therapy in the Management of Prostate Cancer
Conditions
Prostate CancerSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Grace Tan
- 212-746-3208
- [email protected]
Principal Investigator
- Tim McClure, M.D.
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
Outcome Measures
Primary Outcome Measures
Prostate biopsy Gleason grade
Secondary Outcome Measures
Patient characteristics/demographics
MRI PI-RAD grade
Lab results - PSA level
Patient-reported quality of life: EPIC-26
Patient-reported quality of life: IIEF-5
Patient-reported quality of life: MSHQ-EjD
Patient-reported quality of life: IPSS
Timeline
Last Updated
February 29, 2024Start Date
April 10, 2018Today
January 23, 2025Completion Date ( Estimated )
September 1, 2039
Sponsors of this trial
Lead Sponsor
Weill Medical College of Cornell UniversityCollaborating Sponsors
Prostate Cancer Foundation, OPKO Diagnostics, LLC