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RecruitingObservational

Ablative Therapy in the Management of Prostate Cancer

NCT ID: NCT03492424Sponsor: Weill Medical College of Cornell UniversityLast updated: 2025-12-23

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.

Arms & interventions

  • Devicecryotherapy

    Subjects will receive focal cryotherapy for treatment of prostate cancer

Outcome measures

Primary

  • Prostate biopsy Gleason grade

    Will be obtained through patient biopsy pathology results

    Time frame: 12 months

Secondary

  • Patient characteristics/demographics

    Time frame: 12 months

  • MRI PI-RAD grade

    Time frame: 12 months

  • Lab results - PSA level

    Time frame: 12 months

  • Patient-reported quality of life: EPIC-26

    Time frame: 12 months

  • Patient-reported quality of life: IIEF-5

    Time frame: 12 months

  • Patient-reported quality of life: MSHQ-EjD

    Time frame: 12 months

  • Patient-reported quality of life: IPSS

    Time frame: 12 months

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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

Study locations (1)

Weill Cornell Medicine

New York, New York, 10065

Recruiting
Holly Kuczynski · Contact
Tim McClure, M.D. · Principal Investigator
Ablative Therapy in the Management of Prostate Cancer | Cancerify