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

Prostate Cancer Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02790216
• Other study ID #: SHEBA-15-2845-ZS-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: May 6, 2016
• Last updated: May 29, 2016
• Start date: June 2016
• Est. completion date: June 2020

Study information

• Verified date: May 2016
• Source: Sheba Medical Center
• Contact: Zvi Symon, MD
• Phone: 97235308175
• Email: symonz[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: June 2020
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Israel	Sheba_Medical_Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Biochemical failure as determined by Prostate specific antigen greater than nadir+2 ng/ml		3 years	No
Secondary	Urinary , Sexual ,Bowel and Vitality function domains	Expanded Prostate Inventory Composite (EPIC)	6 months and then at years one , two and three	No