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

NCT02790216 | Unknown

• 1 other identifier: SHEBA-15-2845-ZS-CTIL
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Image guided brachytherapy

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with a positive biopsy outside the defined High risk Planning Target Volume

  Negative biopsy outside the high risk planning target volume will confirm the accuracy of the MRI TRUS elastic fusion algorithm to locate the tumor

  Pathological report due one month after brachytherapy implant

Secondary Outcomes (2)

• Biochemical failure as determined by Prostate specific antigen greater than nadir+2 ng/ml

  3 years

• Urinary , Sexual ,Bowel and Vitality function domains

  6 months and then at years one , two and three

Study Arms (1)

Brachytherapy

men eligible for monotherapy seed implant brachytherapy

Procedure: Brachytherapy

Interventions

Brachytherapy PROCEDURE

Biopsies will be obtained after intraoperative plan to rule out significant cancer outside a high risk planning target volume

Brachytherapy

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

men eligible for prostate brachytherapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba_Medical_Center

Tel Litwinsky, 5262160, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsies will be obtained using a transperineal approach

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Zvi Symon, MD

  Chaim Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zvi Symon, MD

CONTACT

97235308175; symonz@sheba.health.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: June 3, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2020
• Last Updated: June 3, 2016

Record last verified: 2016-05

Locations

IL (1)