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Deformable Registration of Multi-parametric MRI to Intra-operative Transrectal Ultrasound for Prostate Brachytherapy

This study is not yet open for participant recruitment.
Verified May 2016 by Sheba Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02790216
First Posted: June 3, 2016
Last Update Posted: June 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sheba Medical Center
  Purpose

Objective:

To focus the high dose radiation to the gross tumor in the prostate while maintaining adequate dose for control of microscopic disease elsewhere in the prostate.

In order to test the incorporation of the robust MRI and TRUS fusion algorithm in the clinical setting the investigators planned a study of Focused therapy with a primary endpoint of accurate localization of the high risk region. This is a pilot study of dose painted permanent I-125 seed implant to verify absence of tumor cells outside a high risk region using multi-parametric MRI and deformable TRUS registration. The high risk region will be dose painted to 160 Gy and the rest of the prostate will receive the normal prescription dose.


Condition Intervention
Prostate Cancer Procedure: Brachytherapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Phase II Study of Focused Dose Painted I-125 Brachytherapy for Low to Intermediate Risk Prostate Cancer Using Deformable Registration of Multi-parametric MRI (Magnetic Resonance Imaging) to Intra-operative TRUS (Trans Rectal Ultrasound)

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Percentage of patients with a positive biopsy outside the defined High risk Planning Target Volume [ Time Frame: Pathological report due one month after brachytherapy implant ]
    Negative biopsy outside the high risk planning target volume will confirm the accuracy of the MRI TRUS elastic fusion algorithm to locate the tumor


Secondary Outcome Measures:
  • Biochemical failure as determined by Prostate specific antigen greater than nadir+2 ng/ml [ Time Frame: 3 years ]
  • Urinary , Sexual ,Bowel and Vitality function domains [ Time Frame: 6 months and then at years one , two and three ]
    Expanded Prostate Inventory Composite (EPIC)


Biospecimen Retention:   Samples Without DNA
Biopsies will be obtained using a transperineal approach

Estimated Enrollment: 24
Study Start Date: June 2016
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Brachytherapy
men eligible for monotherapy seed implant brachytherapy
Procedure: Brachytherapy
Biopsies will be obtained after intraoperative plan to rule out significant cancer outside a high risk planning target volume

Detailed Description:

Primary end-point:

Feasibility of dose painting will be determined by the absence of tumor outside the high-risk region on an intra-operative trans-perineal biopsy.

Frozen sections will not be obtained, however on receipt of the final pathology 2-4 weeks after the procedure 2 possible scenarios arise:

  1. There is no evidence of cancer: this confirms the accuracy of the TRUS MRI registration.
  2. There is evidence of tumor on the stereotactic biopsy: In this case a regular dosimetric check (this is performed in the Standard of care procedure and is known as post-operative dosimetry) will be performed to determine whether adequate dose was delivered. If not, as the involved needle position was recorded in the treatment plan and labeled with co-ordinates, the regular possibility of accurately adding radioactive seeds is possible.
  Eligibility

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
men eligible for prostate brachytherapy
Criteria

Inclusion Criteria:

  • Men suitable for monotherapy with permanent Iodine 125 implant

    • Age > 50 yrs
    • PS 0-2 (WHO)
    • Histologic diagnosis of prostate adenocarcinoma made on transrectal guided prostate biopsy with no fewer than 12 cores taken
    • No more than 50% of cores involved (summary)
    • MRI of Prostate with Diffusion Weighted Imaging and Dynamic Contrast Enhancement with demonstrable lesion compatible with biopsy result
    • Gleason sum no greater than 3+4 =7 in any core
    • Clinical T stage no higher than T T (tumor) 2A
    • Prostate volume ≤60 cc
    • Serum prostate-specific antigen (PSA) no higher than 15 ng/mL
    • No prior history of malignancy except non-melanoma skin cancer
    • Must be suitable for general or spinal anesthesia

Exclusion Criteria:

Have anesthesia surgical assignment category IV or greater

  • Cannot cease anti-coagulant therapy
  • Had a malignancy, other than prostate or skin cancer (except malignant melanoma), within 5 years
  • urethral stricture
  • Prior prostate cancer therapies
  Contacts and Locations
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): NCT02790216


Contacts
Contact: Zvi Symon, MD 97235308175 symonz@sheba.health.gov.il

Locations
Israel
Sheba_Medical_Center
Tel Hashomer, Israel, 5262160
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Zvi Symon, MD Chaim Sheba Medical Center
  More Information

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02790216     History of Changes
Other Study ID Numbers: SHEBA-15-2845-ZS-CTIL
First Submitted: May 6, 2016
First Posted: June 3, 2016
Last Update Posted: June 3, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sheba Medical Center:
Image guided brachytherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases