Clinical trial · Interventional
Using Ultrasound Spectrum Analysis (USA) to Guide Dose Escalated Prostate Brachytherapy
Phase I/II Evaluation of Cancer-Specific Imaging Using Ultrasound Spectrum Analysis (USA) to Guide Dose Escalated Prostate Brachytherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clinical Stage T2b or Less of Prostate Cancer | — | UNRESOLVED | — |
| Prostate Brachytherapy | — | UNRESOLVED | — |
| Transrectal Prostate Ultrasound Treatment Planning | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| An ultrasound-based technique to identify prostate cancer | Other | — | UNRESOLVED |
| pre-implant transrectal ultrasound images and planning | Other | — | UNRESOLVED |
| ultrasound-based cancer-specific images | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- pre-implant transrectal ultrasound images and planning
- description
- Transrectal ultrasound session will be performed at a separate session prior to the implant.
- interventionNames
- Other: An ultrasound-based technique to identify prostate cancer
- Other: pre-implant transrectal ultrasound images and planning
- Other: ultrasound-based cancer-specific images
Primary outcomes (1)
- measure
- modified B+K ultrasound-based tissue-type images
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * No prior hormone therapy * No prior radiotherapy * No history of collagen vascular disease * No history of inflammatory bowel disease
References
Publications (1)
- RESULTEnnis 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