Examination of Focal Therapies- MRI-Fusion, HIFU, NanoKnife and Cryotherapy

June 11, 2019 updated by: Rabin Medical Center

Examination of Focal Therapies - MRI-Fusion, HIFU, NanoKnife and Cryotherapy

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

1000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
MRI-US Fusion
patients undergoing MRI targeted prostate biopsy
Focal
patients undergoing focal treatment for localized prostate cancer (HIFU, NanoKnife, Cryotherapy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: David Margel, MD PhD, Rabin Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2015

Primary Completion (Anticipated)

June 6, 2020

Study Completion (Anticipated)

June 6, 2020

Study Registration Dates

First Submitted

August 15, 2018

First Submitted That Met QC Criteria

June 10, 2019

First Posted (Actual)

June 11, 2019

Study Record Updates

Last Update Posted (Actual)

June 13, 2019

Last Update Submitted That Met QC Criteria

June 11, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0316-16-RMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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