Ablative Therapy in the Management of Prostate Cancer

Recruiting

• Conditions: Prostate Cancer
• Interventions: Device: cryotherapy

• Registration Number: NCT03492424
• Lead Sponsor: Weill Medical College of Cornell University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-02
• Study First Submitted: 2018-03-30
• Study First Submitted QC: 2018-04-06
• Study First Posted: 2018-04-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-29
• Primary Completion: 2032-03
• Study Completion: 2039-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

• >18 years of age
• Undergoing focal therapy for primary or salvage treatment of prostate cancer, or
• Have received prior focal therapy

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Exclusion Criteria

• Clinically-evident metastatic disease
• Unable to fill out an English-language questionnaire

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Focal therapy for prostate cancer	cryotherapy	All men \>18 years of age undergoing focal therapy for primary or salvage treatment of prostate cancer will be included. Men who had received prior focal therapy are also eligible for inclusion. 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.

Primary Outcome Measures

Name	Time	Method
Prostate biopsy Gleason grade	12 months	Will be obtained through patient biopsy pathology results

Secondary Outcome Measures

Name	Time	Method
Patient characteristics/demographics	12 months	Will be obtained through patient medical history in electronic health record
MRI PI-RAD grade	12 months	Will be obtained through patient MRI radiology results
Lab results - PSA level	12 months	Will obtain patient PSA (ng/mL) through laboratory (blood) results
Patient-reported quality of life: MSHQ-EjD	12 months	Male Sexual Health questionnaire to assess ejaculatory function
Patient-reported quality of life: EPIC-26	12 months	Expanded Prostate Cancer Index Composite (short form) questionnaire to assess quality of life
Patient-reported quality of life: IIEF-5	12 months	The International Index of Erectile Function questionnaire to assess erectile function
Patient-reported quality of life: IPSS	12 months	International Prostate Symptom Score questionnaire to assess urinary function and quality of life

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States