Using Ultrasound Spectrum Analysis (USA) to Guide Dose Escalated Prostate Brachytherapy

NCT01227642 | Completed Phase 1 DMC

• 1 other identifier: 06-147
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

In standard treatment, the seeds are placed throughout the prostate to treat the entire prostate. This is done because it was impossible to know where the cancer was located within the prostate. A new technique has been developed using the same ultrasound imaging that you probably had when you had your biopsy. Using this technique, areas likely to contain prostate cancer can be identified.In this early study of 15 subjects, we will test if this method to plan your prostate seed implant is safe and can be done as part of regular care. Areas identified as suspicious for cancer will be treated with higher doses of radiation while those areas not demonstrating cancer will be treated to the standard minimum dose. The higher dose areas will receive two times the minimum dose the prostate usually receives. Because this technique is not perfect, those areas not identified as cancerous should be treated in case there is a cancer area that the technique did not identify. Subjects enrolled in this study will then be followed with this ultrasound technique over the next two years to monitor the changes to the cancerous areas and will undergo a biopsy two years after the procedure. Subjects will, of course, be monitored to assess the success of the technique and its side effects.

Conditions

Clinical Stage T2b or Less of Prostate Cancer; Prostate Brachytherapy; Transrectal Prostate Ultrasound Treatment Planning

Keywords

Prostate Cancer; Prostate brachytherapy; Ultrasound treatment planning

Outcome Measures

Primary Outcomes (1)

• modified B+K ultrasound-based tissue-type images

  2 years

Study Arms (1)

pre-implant transrectal ultrasound images and planning

EXPERIMENTAL

Transrectal ultrasound session will be performed at a separate session prior to the implant.

Other: An ultrasound-based technique to identify prostate cancer; Other: pre-implant transrectal ultrasound images and planning; Other: ultrasound-based cancer-specific images

Interventions

An ultrasound-based technique to identify prostate cancer OTHER

The technique uses current ultrasound equipment already in use for prostate brachytherapy guidance.By extracting and processing the radiofrequency signal obtained from the ultrasound transducer in ways not done to create the standard B-mode ultrasound image, areas of cancer can be identified and displayed overlying the standard B-mode ultrasound image. Comparing the results with this technique to the results of prostate biopsies demonstrates a high degree of accuracy with the area under the receiver-operator characteristic curve of 0.87, a result superior to any other imaging methods.

pre-implant transrectal ultrasound images and planning

pre-implant transrectal ultrasound images and planning OTHER

an ultrasound-based technique to identify cancer-containing areas within the prostate.

pre-implant transrectal ultrasound images and planning

ultrasound-based cancer-specific images OTHER

ultrasound-based cancer-specific images of the prostate prior to the brachytherapy and use them to direct the dosimetry planning

Also known as: The ultrasound unit used is the B+K Hawk 2102 with probe #8658.

pre-implant transrectal ultrasound images and planning

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical stage ≤ T2b according to the American Joint Commission on Cancer 6th Edition28
• PSA ≤ 10 ng/ml
• Gleason sum on biopsy ≤ 6
• Prostate volume ≤ 50 cc
• Willing to continue follow-up for at least two years.

You may not qualify if:

• No prior hormone therapy
• No prior radiotherapy
• No history of collagen vascular disease
• No history of inflammatory bowel disease

Sponsors & Collaborators

• Beth Israel Medical Center: lead
• Riverside Research Institute: collaborator

Study Sites (1)

St.Luke's-Roosevelt Hospital Center

New York, New York, 10019, United States

Location

Related Publications (1)

• Ennis RD, Quinn SA, Trichter F, Ryemon S, Jain A, Saigal K, Chandrashekhar S, Romas NA, Feleppa EJ. Phase I/II prospective trial of cancer-specific imaging using ultrasound spectrum analysis tissue-type imaging to guide dose-painting prostate brachytherapy. Brachytherapy. 2015 Nov-Dec;14(6):801-8. doi: 10.1016/j.brachy.2015.06.011. Epub 2015 Jul 31.

  PMID: 26235201 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Ronald Ennis, MD

  St. Luke's-Roosevelt Hospital Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: October 25, 2010
• Study Start: February 1, 2007
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 14, 2016

Record last verified: 2016-03

Locations

US (1)