Contrast Enhanced Transrectal Ultrasonography (TRUS) to Assess Prostatic Vascularity After Radiotherapy (XRT)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Contrast Enhanced Transrectal Ultrasound (TRUS)
|
Drug: 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]).
|
Outcome Measures
Primary Outcome Measures
- Measurable Decrease in Prostate Vascularity During and/or After Radiation Treatment [1 year]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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 >
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
Sponsors and Collaborators
- Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
- Principal Investigator: Edouard J Trabulsi, MD, Thomas Jefferson University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Halpern EJ, Frauscher F, Rosenberg M, Gomella LG. Directed biopsy during contrast-enhanced sonography of the prostate. AJR Am J Roentgenol. 2002 Apr;178(4):915-9.
- Halpern EJ, Frauscher F, Strup SE, Nazarian LN, O'Kane P, Gomella LG. Prostate: high-frequency Doppler US imaging for cancer detection. Radiology. 2002 Oct;225(1):71-7.
- Linden RA, Halpern EJ. Advances in transrectal ultrasound imaging of the prostate. Semin Ultrasound CT MR. 2007 Aug;28(4):249-57. Review.
- Nelson ED, Slotoroff CB, Gomella LG, Halpern EJ. Targeted biopsy of the prostate: the impact of color Doppler imaging and elastography on prostate cancer detection and Gleason score. Urology. 2007 Dec;70(6):1136-40.
- 07D.218
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Contrast Enhanced Transrectal Ultrasound (TRUS) |
|---|---|
| Arm/Group Description | 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]). |
| Period Title: Overall Study | |
| STARTED | 1 |
| COMPLETED | 1 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Contrast Enhanced Transrectal Ultrasound (TRUS) |
|---|---|
| Arm/Group Description | 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]). |
| Overall Participants | 1 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
1
100%
|
| >=65 years |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
0
0%
|
| Male |
1
100%
|
| Region of Enrollment (Count of Participants) | |
| United States |
1
100%
|
Outcome Measures
| Title | Measurable Decrease in Prostate Vascularity During and/or After Radiation Treatment |
|---|---|
| Description | |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| This trial did not accrue well and was terminated prematurely. No data were not collected or analyzed. |
| Arm/Group Title | Contrast Enhanced Transrectal Ultrasound (TRUS) |
|---|---|
| Arm/Group Description | 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]). |
| Measure Participants | 0 |
| Title | Sonographic Appearance of Prostate and Prostate Vascularity Before, During and After External Beam Radiotherapy (Standard of Care) for Prostate Cancer |
|---|---|
| Description | |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| This trial did not accrue well and was terminated prematurely. No data were not collected or analyzed. |
| Arm/Group Title | Contrast Enhanced Transrectal Ultrasound (TRUS) |
|---|---|
| Arm/Group Description | 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]). |
| Measure Participants | 0 |
| Title | Patient Tolerance of TRUS Evaluation During/After Radiation Treatment |
|---|---|
| Description | |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| This trial did not accrue well and was terminated prematurely. No data were not collected or analyzed. |
| Arm/Group Title | Contrast Enhanced Transrectal Ultrasound (TRUS) |
|---|---|
| Arm/Group Description | 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]). |
| Measure Participants | 0 |
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Contrast Enhanced Transrectal Ultrasound (TRUS) | |
| Arm/Group Description | 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]). | |
All Cause Mortality |
||
| Contrast Enhanced Transrectal Ultrasound (TRUS) | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Contrast Enhanced Transrectal Ultrasound (TRUS) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Contrast Enhanced Transrectal Ultrasound (TRUS) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Edouard Trabulsi |
|---|---|
| Organization | Sidney Kimmel Cancer Center at Thomas Jefferson University |
| Phone | 215-955-1000 |
| edouard.trabulsi@jefferson.edu |
- 07D.218