Prostate CancerNCT02024178
Ultrasound Imaging in Finding Prostate Cancer in Patients Undergoing Surgery
A study testing Ultrasound Imaging in people with Prostate Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
This pilot clinical trial studies ultrasound imaging in finding prostate cancer in patients undergoing surgery. Diagnostic procedures, such as ultrasound imaging, may help find and diagnose prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Ultrasound Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have completed a staging multiparametric MRI at New York University (NYU)
- Patients who plan to undergo radical prostatectomy by open or robotic approach
Who cannot join
- Previous History of Prostate Cancer Radiation Treatment
- Focal Ablation of the prostate for cancer treatment
- Men receiving hormonal ablation within 6 months prior to undergoing radical prostatectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Smilow Comprehensive Prostate Cancer Center
New York, New York, 10016
About this study
Official title: A Pilot Evaluation of the Efficacy of HistoScanning™ in Predicting the Presence and Location of Prostate Cancer in Men Undergoing Radical Prostatectomy
This pilot clinical trial studies ultrasound imaging in finding prostate cancer in patients undergoing surgery. Diagnostic procedures, such as ultrasound imaging, may help find and diagnose prostate cancer. This study will serve as an analysis of the Histo-Scanning technology for the purpose of determining its ability to identify sites of prostate cancer at the time of prostate ultrasound.
- Conditions
- Prostate Cancer
- Being tested
- Ultrasound Imaging
- Keywords
- Prostate Cancer, Radical Prostatectomy, Ultrasound Imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ImagingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Imaging | Experimental | Men already electing to undergo radical prostatectomy will undergo transrectal ultrasound procedure at induction of anesthesia prior to their surgery procedure. Receives: Procedure: Ultrasound Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Histoscan findings with Radical Prostatectomy Pathology
Compare location and concordance of findings on pre-op MRI \& Histoscan with radical prostatectomy specimen
Measured: up to 3 years
Secondary outcomes (1)
Extent of tumor and grade in treatment planning
Describe correlation between tumor grade on final pathology and histoscan findings
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startJun 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samir Taneja, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024178
- Sponsor's protocol ID
- NYU11-00220
- Status last verified
- Jun 2016
- First submitted
- 26 Dec 2013
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Evaluation of the Efficacy of HistoScanning™ in Predicting the Presence and Location of Prostate Cancer in Men Undergoing Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT02024178
- Acronym / sponsor ID
- NYU11-00220
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Radical Prostatectomy, Ultrasound Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies ultrasound imaging in finding prostate cancer in patients undergoing surgery. Diagnostic procedures, such as ultrasound imaging, may help find and diagnose prostate cancer. This study will serve as an analysis of the Histo-Scanning technology for the purpose of determining its ability to identify sites of prostate cancer at the time of prostate ultrasound.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Imaging | Experimental | Procedure: Ultrasound ImagingMen already electing to undergo radical prostatectomy will undergo transrectal ultrasound procedure at induction of anesthesia prior to their surgery procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have completed a staging multiparametric MRI at New York University (NYU)
- Patients who plan to undergo radical prostatectomy by open or robotic approach
Key exclusion criteria (3 listed)
- Previous History of Prostate Cancer Radiation Treatment
- Focal Ablation of the prostate for cancer treatment
- Men receiving hormonal ablation within 6 months prior to undergoing radical prostatectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Imaging | Procedure or surgery | Ultrasound Imaging |
Primary outcome
Correlation of Histoscan findings with Radical Prostatectomy Pathology
Time frame: up to 3 years
Compare location and concordance of findings on pre-op MRI \& Histoscan with radical prostatectomy specimen
1 secondary outcome
Extent of tumor and grade in treatment planning
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Taneja, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Imaging in people with Prostate Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Histoscan findings with Radical Prostatectomy Pathology (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016.