Contrast Enhanced Transrectal Ultrasonography (TRUS) to Assess Prostatic Vascularity After Radiotherapy (XRT)
| Status: | Terminated |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 9/21/2018 |
| Start Date: | June 2007 |
| End Date: | May 12, 2011 |
Contrast Enhanced Transrectal Ultrasound (TRUS) to Assess Prostatic Vascularity as a Measure of Treatment Response and Early Prediction of Treatment Failure After XRT
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 radiotherapy treatments typically decrease or suppress tumor - associated
vascularity through several mechanisms, including apoptosis (process of cell death) and
anti-angiogenic pathways (ways to destroy new blood vessel growth). Previously at the
investigators' center, they have demonstrated that increased prostatic vascularity (blood
vessels defined to prostate) detected ultrasonographically correlated with disease free
survival after radical prostatectomy (surgical removal of entire prostate), and may be
indicative of higher grade, higher stage disease. The significance of prostate neovascularity
in response to treatment with external beam radiotherapy (EBRT) (standard of care) has not
been well studied. The investigators hypothesize that prostate cancer that recurs after
radiotherapy may exhibit measurable patterns of tumor-associated vascularity, which may
represent a minimally invasive marker of cancer stage, grade and response to treatment. The
investigators propose a pilot study to assess the feasibility of serial enhanced transrectal
ultrasonography (TRUS) examinations during and after radiotherapy for prostate cancer.
(growth of new blood vessels to feed the tumor) with increased microvessel density. Systemic,
hormonal, and radiotherapy treatments typically decrease or suppress tumor - associated
vascularity through several mechanisms, including apoptosis (process of cell death) and
anti-angiogenic pathways (ways to destroy new blood vessel growth). Previously at the
investigators' center, they have demonstrated that increased prostatic vascularity (blood
vessels defined to prostate) detected ultrasonographically correlated with disease free
survival after radical prostatectomy (surgical removal of entire prostate), and may be
indicative of higher grade, higher stage disease. The significance of prostate neovascularity
in response to treatment with external beam radiotherapy (EBRT) (standard of care) has not
been well studied. The investigators hypothesize that prostate cancer that recurs after
radiotherapy may exhibit measurable patterns of tumor-associated vascularity, which may
represent a minimally invasive marker of cancer stage, grade and response to treatment. The
investigators propose a pilot study to assess the feasibility of serial enhanced transrectal
ultrasonography (TRUS) examinations during and after radiotherapy for prostate cancer.
Inclusion Criteria:
- 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 Criteria:
- 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.
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