Examination of Focal Therapies- MRI-Fusion, HIFU, NanoKnife and Cryotherapy
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|ClinicalTrials.gov Identifier: NCT03982706|
Recruitment Status : Enrolling by invitation
First Posted : June 11, 2019
Last Update Posted : June 13, 2019
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Examination of Focal Therapies - MRI-Fusion, HIFU, NanoKnife and Cryotherapy|
|Actual Study Start Date :||October 28, 2015|
|Estimated Primary Completion Date :||June 6, 2020|
|Estimated Study Completion Date :||June 6, 2020|
patients undergoing MRI targeted prostate biopsy
patients undergoing focal treatment for localized prostate cancer (HIFU, NanoKnife, Cryotherapy)
- PSA change after focal therapy (HIFU, Nano-Knife and Cryotherapy) [ Time Frame: 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
- Prostate cancer detection rate and clinically significant prostate cancer detection rate of MRI-US FUSION biopsy. [ Time Frame: 5 years ]clinically significant prostate cancer is defined as Gleason 7 and above
- Change in urinary symptoms measured by International Prostate Symptom Score (IPSS) questioner [ Time Frame: 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
- Change in erectile function measured by International Index of Erectile Function (IIEF-5) questioner [ Time Frame: 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 procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982706
|Principal Investigator:||David Margel, MD PhD||Rabin Medical Center|