Prostate CancerPhase 3NCT00911027
SonoVue Guided Prostate Biopsy
A Phase 3 study testing Contrast-enhanced ultrasound guided biopsy and ultrasound guided systematic biopsy in people with Prostate Cancer, run by Bracco Diagnostics, Inc at 17 sites in 7 countries.
Trial summary
This is a phase III European multicenter, open label, prospective study to assess the diagnostic accuracy of the use of SonoVue contrast agent to guide prostate biopsies in comparison with the current practice of ultrasound guided systematic biopsy. The trial will involve 15-20 European Centers. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Contrast-enhanced ultrasound guided biopsy and ultrasound guided systematic biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 17 sitesin 7 countries
- Study dates
- Feb 2009to Mar 2011
- Phase
- Phase 3
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patient, age ≥ 40 years old
- Optimization part only: Diagnosis of prostate cancer
- Main part: Suspected prostate cancer scheduled for first biopsy and tPSA ≤ 10 ng/mL OR already submitted to one systematic bioptic procedure with negative results currently under follow up procedure due to a persistent indication.
- Written Informed Consent and willing to comply with protocol requirements
Who cannot join
- Documented acute prostatitis or urinary tract infections
- Known allergy to sulphur hexafluoride micro bubbles
- Any clinically unstable cardiac condition within 7 days prior to SonoVue® administration such as:
- evolving or ongoing myocardial infarction
- typical angina at rest within the previous 7 days
- significant worsening of cardiac symptoms within the previous 7 days
Show all 15Show fewer
- recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of ECG, laboratory or clinical findings)
- acute cardiac failure, class III/IV cardiac failure
- severe cardiac rhythm disorders
- right-to-left shunts
- Severe pulmonary hypertension or uncontrolled systemic hypertension or respiratory distress syndrome
- Bioptic procedure within 30 days before admission into this study (this exclusion criterion is only for the main part of the study)
- Determined by the Investigator that the patient is clinically unsuitable for the study
- Participation in a concurrent clinical trial or in another trial within the past 30 days
- Repeated participation in this trial (the patient should not be enrolled twice in the present study)
Trial locations and contacts
17 sites in 7 countries.
17 sites in 7 countries
Italy6 sites
Orsola-Malpighi Hospital, Urology and Radiology Unit "Malpighi"
Bologna, 40138
Ospedale Valduce
Como, 22100
European Institute of Oncology
Milan, 20100
I.R.C.C.S. San Raffaele
Milan, 20132
University of Palermo
Palermo, 90127
University of Trieste
Trieste, 34149
France3 sites
Hôpital Edouard Herriot
Lyon, 69437
Hôpital Necker-Enfants Malades
Paris, 75743
CHRU Tours - Hôpital Bretonneau
Tours, 37044
Germany3 sites
Institut für Radiologie der Charité
Berlin, 10117
Martini-Klinik, Prostate Cancer Center
Hamburg, 20246
Urologische Klinik und Poliklinik
Munich, 81377
Netherlands2 sites
AMC University Amsterdam
Amsterdam, 1100 DD
Erasmus MC
Rotterdam, 3015 CE
United Kingdom1 site
Imperial College NHS Trust - Charing Cross
London, W6 8RF
About this study
Official title: A Phase III Study to Compare SonoVue Guided Prostate Biopsy With Systematic Biopsy in the Detection of Prostate Malignant Lesions in Patients With Suspected Prostate Cancer
This is a phase III European multicenter, open label, prospective study to assess the diagnostic accuracy of the use of SonoVue contrast agent to guide prostate biopsies in comparison with the current practice of ultrasound guided systematic biopsy. The trial will involve 15-20 European Centers.
- Conditions
- Prostate Cancer
- Being tested
- Contrast-enhanced ultrasound guided biopsy, ultrasound guided systematic biopsy
- Keywords
- Prostate, Cancer, Biopsy, Guided, Contrast, Enhanced, SonoVue, Suspicion of prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced ultrasound guided biopsyDrug
Also called SonoVue guided biopsy
One to two bolus (each 2.4mL) of SonoVue per patient in the optimization part
One to four bolus (each 2.4mL) of SonoVue per patient in the main part
ultrasound guided systematic biopsyProcedure or surgery
Current practice of ultrasound guided systematic biopsy
| Study group | Role | What they receive |
|---|---|---|
| SonoVue guided biopsy | Experimental | Not described Receives: Drug: Contrast-enhanced ultrasound guided biopsy |
| Systematic biopsy | Other | Not described Receives: Procedure: ultrasound guided systematic biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of potentiality of SonoVue to guide prostate biopsy increasing detection rate of malignant lesions of 6% points (absolute terms) compared to detection rate of conventional systematic biopsy on patients candidates to a bioptic procedure.
Measured: Day 1
Secondary outcomes (3)
Evaluation of the rate of patients negative to the systematic biopsy among the population that will not receive the targeted biopsy
Measured: Day 1
Assessment of potentiality of SonoVue guided biopsy to increase % of positive bioptic cores compared to % of positive cores obtained with systematic biopsy, intra-patient in the population of the patients that received both bioptic procedures.
Measured: Day 1
Evaluation of the Gleason Score of bioptic samples and its relationship with the contrast enhanced signal assessment scores.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Failure to meet primary objective
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.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bracco Diagnostics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bracco Imaging S.p.A.
- Responsible party
- Sponsor
- Investigators
- Maria L Storto, MD, Study chair, Bracco Diagnostics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911027
- Sponsor's protocol ID
- BR1-127
- Status last verified
- Apr 2012
- First submitted
- 7 May 2009
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study to Compare SonoVue Guided Prostate Biopsy With Systematic Biopsy in the Detection of Prostate Malignant Lesions in Patients With Suspected Prostate Cancer
- ClinicalTrials.gov ID
- NCT00911027
- Acronym / sponsor ID
- BR1-127
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Cancer, Biopsy, Guided, Contrast, Enhanced, SonoVue, Suspicion of prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to meet primary objective
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
- Collaborators
- Bracco Imaging S.p.A.
- Study start
- Feb 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 1 Jun 2009 (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 is a phase III European multicenter, open label, prospective study to assess the diagnostic accuracy of the use of SonoVue contrast agent to guide prostate biopsies in comparison with the current practice of ultrasound guided systematic biopsy. The trial will involve 15-20 European Centers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SonoVue guided biopsy | Experimental | Drug: Contrast-enhanced ultrasound guided biopsy |
| Systematic biopsy | Other | Procedure: ultrasound guided systematic biopsy |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male patient, age ≥ 40 years old
- Optimization part only: Diagnosis of prostate cancer
- Main part: Suspected prostate cancer scheduled for first biopsy and tPSA ≤ 10 ng/mL OR already submitted to one systematic bioptic procedure with negative results currently under follow up procedure due to a persistent indication.
- Written Informed Consent and willing to comply with protocol requirements
Key exclusion criteria (15 listed)
- Documented acute prostatitis or urinary tract infections
- Known allergy to sulphur hexafluoride micro bubbles
- Any clinically unstable cardiac condition within 7 days prior to SonoVue® administration such as:
- evolving or ongoing myocardial infarction
- typical angina at rest within the previous 7 days
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 |
|---|---|---|
| Contrast-enhanced ultrasound guided biopsyAlso: SonoVue guided biopsyOne to two bolus (each 2.4mL) of SonoVue per patient in the optimization part One to four bolus (each 2.4mL) of SonoVue per patient in the main part | Drug | SonoVue guided biopsy |
| ultrasound guided systematic biopsyCurrent practice of ultrasound guided systematic biopsy | Procedure or surgery | Systematic biopsy |
Primary outcome
Determination of potentiality of SonoVue to guide prostate biopsy increasing detection rate of malignant lesions of 6% points (absolute terms) compared to detection rate of conventional systematic biopsy on patients candidates to a bioptic procedure.
Time frame: Day 1
3 secondary outcomes
Evaluation of the rate of patients negative to the systematic biopsy among the population that will not receive the targeted biopsy
Time frame: Day 1
Assessment of potentiality of SonoVue guided biopsy to increase % of positive bioptic cores compared to % of positive cores obtained with systematic biopsy, intra-patient in the population of the patients that received both bioptic procedures.
Time frame: Day 1
Evaluation of the Gleason Score of bioptic samples and its relationship with the contrast enhanced signal assessment scores.
Time frame: Day 1
Results and safety
The study was stopped early (reason given: Failure to meet primary objective). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2012.
Related trials for Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruiting
Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer
Malignant Prostate Neoplasm
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingObservational study
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Prostatic Neoplasms, Prostate Cancer
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
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.
Maria L Storto, MD study chair
Bracco Diagnostics, Inc
17 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Contrast-enhanced ultrasound guided biopsy and ultrasound guided systematic biopsy in people with Prostate Cancer, run by Bracco Diagnostics, Inc at 17 sites in 7 countries.
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 4 inclusion and 15 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: stopped early, as of the sponsor's last update on 25 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Italy, France, Germany, Netherlands, Austria and 2 more countries. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Failure to meet primary objective). Results are not available in the source record.
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?
Determination of potentiality of SonoVue to guide prostate biopsy increasing detection rate of malignant lesions of 6% points (absolute terms) compared to detection rate of conventional systematic biopsy on patients candidates to a bioptic procedure. (time frame: Day 1). 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 25 Apr 2012.