Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT03982706
Status:
UNKNOWN
Last Update Posted:
2019-06-13
First Post:
2018-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Examination of Focal Therapies- MRI-Fusion, HIFU, NanoKnife and Cryotherapy
Sponsor:
Rabin Medical Center
Organization:
Study Overview
Official Title:
Examination of Focal Therapies - MRI-Fusion, HIFU, NanoKnife and Cryotherapy
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: