Prostate Cancer
Conditions
Keywords
Prostate cancer, prostatic vascularity, External Beam Radiation treatment, Contrast Enhanced transrectal Ultrasound
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 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.
Interventions
DRUGContrast Enhanced-Transrectal Ultrasound
Drug Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline \[Visit 2\]); week 5 (middle of treatment \[Visit 3\]); week 10 (end of treatment \[Visit 4\]); week 18 (2 months after end of EBRT \[Visit 5\]); week 26 (4 months after end of EBRT \[Visit 6\]); and week 36 (6 months after end of EBRT \[Visit 7\]).
Sponsors
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurable Decrease in Prostate Vascularity During and/or After Radiation Treatment | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Sonographic Appearance of Prostate and Prostate Vascularity Before, During and After External Beam Radiotherapy (Standard of Care) for Prostate Cancer | 1 year |
| Patient Tolerance of TRUS Evaluation During/After Radiation Treatment | 1 year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Contrast Enhanced Transrectal Ultrasound (TRUS) Contrast Enhanced-Transrectal Ultrasound: Drug Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline \[Visit 2\]); week 5 (middle of treatment \[Visit 3\]); week 10 (end of treatment \[Visit 4\]); week 18 (2 months after end of EBRT \[Visit 5\]); week 26 (4 months after end of EBRT \[Visit 6\]); and week 36 (6 months after end of EBRT \[Visit 7\]). | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Contrast Enhanced Transrectal Ultrasound (TRUS) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment United States | 1 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Measurable Decrease in Prostate Vascularity During and/or After Radiation Treatment
Time frame: 1 year
Population: This trial did not accrue well and was terminated prematurely. No data were not collected or analyzed.
Secondary
Patient Tolerance of TRUS Evaluation During/After Radiation Treatment
Time frame: 1 year
Population: This trial did not accrue well and was terminated prematurely. No data were not collected or analyzed.
Secondary
Sonographic Appearance of Prostate and Prostate Vascularity Before, During and After External Beam Radiotherapy (Standard of Care) for Prostate Cancer
Time frame: 1 year
Population: This trial did not accrue well and was terminated prematurely. No data were not collected or analyzed.