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NCT Number: NCT03492424

Ablative Therapy in the Management of Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Weill Cornell Medicine

New York, 10065, United States

Location status: Recruiting

Location contact

Holly Kuczynski

CONTACT

[email protected]

646-962-7523

Tim McClure, M.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cryotherapy

Device

Subjects will receive focal cryotherapy for treatment of prostate cancer

Primary outcomes

  1. Prostate biopsy Gleason grade

    Time frame: 12 months

    Will be obtained through patient biopsy pathology results

Secondary outcomes

  1. Patient characteristics/demographics

    Time frame: 12 months

    Will be obtained through patient medical history in electronic health record

  2. MRI PI-RAD grade

    Time frame: 12 months

    Will be obtained through patient MRI radiology results

  3. Lab results - PSA level

    Time frame: 12 months

    Will obtain patient PSA (ng/mL) through laboratory (blood) results

  4. Patient-reported quality of life: EPIC-26

    Time frame: 12 months

    Expanded Prostate Cancer Index Composite (short form) questionnaire to assess quality of life

  5. Patient-reported quality of life: IIEF-5

    Time frame: 12 months

    The International Index of Erectile Function questionnaire to assess erectile function

  6. Patient-reported quality of life: MSHQ-EjD

    Time frame: 12 months

    Male Sexual Health questionnaire to assess ejaculatory function

  7. Patient-reported quality of life: IPSS

    Time frame: 12 months

    International Prostate Symptom Score questionnaire to assess urinary function and quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Holly Kuczynsk, BS

CONTACT

[email protected]

646-962-7523

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Prostate Cancer Foundation

Registry information

Important dates

Study start
2018
Primary completion
2032
Study completion
2039
First posted
Apr 10, 2018
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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