Clinical trial · Interventional
Evaluation Ultrasound Elasticity/Tissue Strain-Hardening Imaging for Prostate Cancer Patients Undergoing Radical Prostatectomy
A Pilot Trial Evaluation of Ultrasound Elasticity/Tissue Strain-Hardening Imaging for Prostate Cancer in Patients Undergoing Radical Prostatectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Technical Issues
Summary
Brief summary (as posted)
The primary objective is to perform a pilot trial evaluation of a novel prostate ultrasound imaging software utilizing tissue elasticity measurements to identify tumor foci among men who will undergo radical prostatectomy for localized prostate cancer. As a secondary objective, investigators will compare elasticity measured tumor foci volume to the measured volume from radical prostatectomy pathologic examination.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tissue Elastography Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tissue Elastography Imaging
- description
- Using special elastography software, probe pressed gently against prostate during routine ultrasound before prostate surgery, 10-15 minutes process.
- interventionNames
- Procedure: Tissue Elastography Imaging
Primary outcomes (1)
- measure
- Evaluation of diagnostic technique (using tissue elastography) for prostate cancer detection in men scheduled to undergo a radical prostatectomy
- timeFrame
- 2 Years
- description
- Pilot evaluation of novel prostate ultrasound imaging software utilizing tissue elasticity measurements to identify tumor foci among men who will undergo radical prostatectomy for localized prostate cancer. The methods of Bland and Altman (1986) used to assess whether the tumor volume estimated by the ultrasound imaging technique agrees with the tumor volume measured at pathology. An ultrasound based elasticity measurement technique will detect differences in prostate hardness by using sophisticated mathematical techniques to analyze ultrasound images obtained before and after small compressions of the prostate gland with the ultrasound probe, detecting differences in hardness by measuring relative displacements of portions of the gland. Elasticity images obtained during standard, medically-indicated prostate sonography.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: 1. Patients selected for radical prostatectomy (any technique) at MDACC 2. Histologic diagnosis of prostate cancer, clinical stage cT1c-cT3b 3. Serum prostate specific antigen less than 30 ng/ml. 4. Any Gleason score 5. Total prostate volume of 20-60 cc, measured by outside ultrasound or clinical examination at MDACC. 6. Group 1: high volume disease. At least 3 positive cores containing cancer on one side of the prostate Group 2: low volume disease. Less than 50% tumor length in a single positive core on one side of the prostate Exclusion Criteria: 1. Prior radiation therapy to the pelvis 2. Prior hormonal therapy within 3 months (including LH/RH agonists, estrogens, testosterone receptor blockade, finasteride, dutasteride)
References
Publications (0)
Data not yet available