Status:
TERMINATED
Contrast Enhanced Transrectal Ultrasonography (TRUS) to Assess Prostatic Vascularity After Radiotherapy (XRT)
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Conditions:
Prostate Cancer
Eligibility:
MALE
40-80 years
Phase:
NA
Brief Summary
Solid tumors, including prostate cancer, commonly exhibit tumor-associated neovascularity (growth of new blood vessels to feed the tumor) with increased microvessel density. Systemic, hormonal, and ra...
Eligibility Criteria
Inclusion
- Men aged 40 - 80 years old
- Biopsy proven intermediate/high risk clinically localized prostate cancer, as determined by a Gleason score of 7 or higher, clinical stage T2b or higher, or PSA \> 10. Pathology will be confirmed by at least two reviews
- Patients opting for EBRT (external beam radiation therapy, standard of care) without hormonal ablation
- Ability to undergo serial TRUS procedures
- Ability to give informed consent
Exclusion
- Subject has known hypersensitivity to octafluoropropane.
- Evidence of distant metastatic disease on staging evaluation
- Previous treatment for prostate cancer, including any form of androgen ablation
- Previous procedures involving the anus or rectum, making serial TRUS difficult or dangerous
- Expected life expectancy less than 10 years
- Baseline testosterone \< 200 ng/dL
- Subject with cardiac shunts and elevated pulmonary hypertension
- Subject has worsening or clinically unstable congestive heart failure.
- Subject has acute myocardial infarction or acute coronary syndrome.
- Subject has ventricular arrhythmias or is high risk for arrhythmias.
- Subject has respiratory failure, severe emphysema or pulmonary emboli.
- Subject has a history of cardiac shunt or pulmonary hypertension.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2011
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00635167
Start Date
June 1 2007
End Date
May 12 2011
Last Update
May 16 2025
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107