Clinical trial NCT03982706: Examination of Focal Therapies- MRI-Fusion, HIFU, NanoKnife and Cryotherapy
Official title: Examination of Focal Therapies - MRI-Fusion, HIFU, NanoKnife and Cryotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: MRI-targeted prostate biopsy
focal treatment
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 1000
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men, age 18-90, which have underwent, or are scheduled to undergo, MRI-US FUSION, HIFU, NanoKnife or Cryotherapy at the Ramat Aviv Medical Center or 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.

Eligibility criteria: Inclusion Criteria:

1. Men who have underwent, or are scheduled to undergo a focal therapy treatment at Ramat Aviv Medical Center or Rabin Medical Center
2. Age 18-90.

Exclusion Criteria:

None.

Primary outcomes:
measure: PSA change after focal therapy (HIFU, Nano-Knife and Cryotherapy)
timeFrame: 5 years
measure: Prostate cancer detection rate and clinically significant prostate cancer detection rate of MRI-US FUSION biopsy.
timeFrame: 5 years
Secondary outcomes:
measure: Change in urinary symptoms measured by International Prostate Symptom Score (IPSS) questioner
timeFrame: 5 years
measure: Change in erectile function measured by International Index of Erectile Function (IIEF-5) questioner
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Rabin Medical Center
name: David Margel, MD PhD
role: PRINCIPAL_INVESTIGATOR
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