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| Name | Class |
|---|---|
| Prostate Cancer Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focal therapy for prostate cancer | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cryotherapy | Device | Subjects will receive focal cryotherapy for treatment of prostate cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| Prostate biopsy Gleason grade | Will be obtained through patient biopsy pathology results | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants are generally healthy men diagnosed with prostate cancer, undergoing focal therapy for treatment of prostate cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Holly Kuczynsk, BS | Contact | 646-962-7523 | hok4001@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tim McClure, M.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | Recruiting | New York | New York | 10065 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |