Ablative Therapy in the Management of Prostate Cancer

Clinicaltrials.gov ID: NCT03492424
db-list-check Status RECRUITING
b-loader Phase
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 200

Conditions

Prostate Cancer

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

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

Time Frame: 12 months

Secondary Outcome Measures

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

Timeline

  • Last Updated
    February 29, 2024
  • Start Date
    April 10, 2018
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    September 1, 2039

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