Ablative Therapy in the Management of Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ablative Therapy in the Management of Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: cryotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Focal therapy for prostate cancer<br>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. | Device: cryotherapy<br>* Subjects will receive focal cryotherapy for treatment of prostate cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate biopsy Gleason grade | Will be obtained through patient biopsy pathology results | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, cryotherapy, focal therapy