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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Prostate Cancer

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.


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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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


  2. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   participant eligibility is based on gender identity.
Accepts Healthy Volunteers:   No
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
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.


Information from the National Library of Medicine

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


Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: David Margel, MD PhD Rabin Medical Center

Publications of Results:

Other Publications:
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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03982706     History of Changes
Other Study ID Numbers: 0316-16-RMC
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rabin Medical Center:
MRI-targeted prostate biopsy
focal treatment