Examination of Focal Therapies- MRI-Fusion, HIFU, NanoKnife and Cryotherapy
- Conditions
- Prostate Cancer
- Registration Number
- NCT03982706
- Lead Sponsor
- Rabin Medical Center
- Brief Summary
The main objective of this study is to determine whether focal-driven therapies for diagnosis and treatment of prostate cancer are preferable over current clinical methods. Different focal procedures will be examined, including magnetic resonance imaging (MRI)-target biopsy, and focal treatment as High Intensity Focused Ultrasound (HIFU), cryoablation and Nano-Knife.
- Detailed Description
Men who are scheduled to undergo a focal therapy will be given patient information sheet, which explains the study in lay terms. Fully informed consent, written or verbal (by phone) will be sought and documented before collecting any research data.
The following information will be collected for all patients:
* Demographic data: date of birth, age, gender, ethnicity, Height, weight.
* Medical History: number and results of previous biopsies, previous Protein Specific Antigen (PSA) tests.
For patients who have undergone or are scheduled to undergo MRI-US FUSION biopsy, the following information will be collected:
* MRI: MRI protocol, MRI results: suspected lesions, apparent diffusion coefficient (ADC) values.
* Biopsy procedure details and results: duration and success of procedure, number of cores taken, pathological results, following treatment (if applicable).
For patients who have undergone or are scheduled to undergo HIFU or Nano-Knife or Cryotherapy the following data will be collected:
* Procedure details.
* Evaluation of success: results of following PSA test, MRI and/or prostate biopsy.
Patients undergoing HIFU, Nano-Knife or Cryotherapy will also be asked to complete two questionnaires: IPSS, a validated lower urinary tract symptom questionnaire, and IIEF, a validated erectile function questionnaire.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 1000
- Men who have underwent, or are scheduled to undergo a focal therapy treatment at Ramat Aviv Medical Center or Rabin Medical Center
- Age 18-90.
None.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prostate cancer detection rate and clinically significant prostate cancer detection rate of MRI-US FUSION biopsy. 5 years clinically significant prostate cancer is defined as Gleason 7 and above
PSA change after focal therapy (HIFU, Nano-Knife and Cryotherapy) 5 years PSA will be taken every 3 months during the first year after procedure, and every 6 months in the next following 4 years
- Secondary Outcome Measures
Name Time Method Change in erectile function measured by International Index of Erectile Function (IIEF-5) questioner 5 years IIEF-5 questioner is a validated tool to assess erectile function in men. Total score is ranged 1-25. Higher values represent a better outcome.
IIEF-5 will be filled before the procedure, every three months during the first year and every six months during the next four years following the procedureChange in urinary symptoms measured by International Prostate Symptom Score (IPSS) questioner 5 years IPSS questioner is a validated tool to assess urinary symptoms. Total score is ranged 0-35. Lower values represent a better outcome.
IPSS will be filled before the procedure, every three months during the first year and every six months during the next four years following the procedure