Prostate Cancer
Conditions
Keywords
prostate cancer, cryotherapy, focal therapy
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.
Interventions
DEVICEcryotherapy
Subjects will receive focal cryotherapy for treatment of prostate cancer
Sponsors
Prostate Cancer Foundation
Weill Medical College of Cornell University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prostate biopsy Gleason grade | 12 months | Will be obtained through patient biopsy pathology results |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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: EPIC-26 | 12 months | Expanded Prostate Cancer Index Composite (short form) questionnaire to assess quality of life |
| Patient characteristics/demographics | 12 months | Will be obtained through patient medical history in electronic health record |
| Patient-reported quality of life: MSHQ-EjD | 12 months | Male Sexual Health questionnaire to assess ejaculatory function |
| Patient-reported quality of life: IPSS | 12 months | International Prostate Symptom Score questionnaire to assess urinary function and quality of life |
| Patient-reported quality of life: IIEF-5 | 12 months | The International Index of Erectile Function questionnaire to assess erectile function |
Countries
United States
Contacts
Primary ContactHolly Kuczynsk, BS
Outcome results
None listed