Prostate CancerPhase 4PHSTT-01NCT01950871
Prostate Guided Biopsy Study Evaluating the Diagnostic Performance of Prostate HistoScanning
A Phase 4 study testing Prostate HistoScanning in people with Prostate Cancer, run by Advanced Medical Diagnostics s.a. at 34 sites in 18 countries.
Trial summary
The primary objective of the PHSTT-01 trial is to determine if prostate HistoScanning (HS) analysis can be used to improve the detection of clinically significant prostate cancer (PCa), and potentially reduce the burden and number of biopsies in routine clinical practice. 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?
- Prostate HistoScanning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 34 sitesin 18 countries
- Study dates
- Oct 2013to Jul 2014
- Phase
- Phase 4
- 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
- Men at risk of PCa scheduled for first biopsy with serum total PSA
- ≤ 20 ng/ml (≤ 10 ng/mL if taking 5-alpha reductase inhibitors) from maximally 3 months ago
- Signed informed consent
Who cannot join
- Previous prostate biopsy
- Confirmed PCa
- PSA > 20 ng/ml (or > 10 ng/mL if taking 5-alpha reductase inhibitors)
- Active urinary tract infection
- Presence/history of any confirmed cancer
- Recent prostatic surgery (past 6 months)
- History of pelvic radiotherapy
Trial locations and contacts
34 sites in 18 countries.
34 sites in 18 countries
Germany8 sites
Medical Center Cancer Center - Prostatazentrum
Braunschweig, 38126
Medical Center PAN Klinik
Cologne, 50667
Medical Center Paracelsus Klinik
Düsseldorf, 40474
Medical Center Martini Klinik - Prostate Cancer Center
Hamburg, 20246
Medical Center Klinikum Herford
Herford, 32049
Medical Center St. Elisabeth Krankenhaus
Leipzig, 04277
Medical Center Klinikum Leverkusen
Leverkusen, 51375
Medical Center Klinikum Wolfsburg Urologie
Wolfsburg, 38440
Austria3 sites
Krankenhaus der Barmherzigen Brüder
Vienna, 1020
Medical Center Hanuschkrankenhaus
Vienna, 1140
Medical Center Med.Landeskrankenhaus Vöcklabruck
Vöcklabruck, 4840
Belgium3 sites
Medical Center Onze Lieve Vrouw Ziekenhuis OLVZ
Aalst, 9300
University Medical Center UZ VUB
Brussels, Brussels Capital, 1090
• University Medical Center Cliniques Universitaires Saint Luc
Brussels, Brussels Capital, 1200
United Kingdom3 sites
Medical Center Blackpool Victoria Hospital
Blackpool, FY38NR
University Medical Center Nuffield Health - University Hospitals Bristol (UHB) - Bristol Royal Infirmary and Southmead Hospitals
Bristol, BS28HW
Medical Center Spire Washington Hospital
Tyne and Wear, NE38 9JZ
Czechia2 sites
Medical Center Urologická klinika - Fakultní nemocnice
Olomouc, 775 20
University Medical Center Všeobecná fakultní nemocnice v Praze (VFN) a 1. -General University Hospital and First Faculty of Medicine Charles University
Prague, 15006
France2 sites
Medical Center Institut Mutualiste Montouris
Paris, 75014
University Medical Center CHU Saint Etienne
Saint-Etienne, 42055
Turkey (Türkiye)2 sites
Medical Center URO-TIP Urological Diagnosis Center
Istanbul, 34740
Medical Center Acıbadem Kozyatağı Hospital
Istanbul, 34742
Bulgaria1 site
University Medical Center St. Marina University Hospital
Varna, 9010
Denmark1 site
• University Medical Center Urinary Tract Surgery - Urology Dpt - Odense Universitetshospital Svendborg Sygehus
Odense C, 5000
Estonia1 site
Medical Center North-Estonian Medical Center Foundation
Tallinn, 13419
Italy1 site
University Medical Center University Vita-Salute, Scientific Institute H. San Raffaele
Milan, 20132
Lithuania1 site
University Medical Center Vilniaus Universiteto Onkologijos Institutas - Santariškiu Clinics
Vilnius, 08406
Netherlands1 site
Medical Center Antoni Van Leeuwenhoek Ziekenhuis - Nederlands Kanker Instituut
Amsterdam, 1066 CX
Russia1 site
University Medical Center Moscow State University of Medicine and Dentistry named after A.I.Evdokimov
Moscow, 127473
Spain1 site
University Medical Center Vall d'Hebron University Hospital - Autonoma Universitat Barcelona
Barcelona, 08035
About this study
Official title: Diagnostic Performance of Prostate HistoScanningTM (PHS) in Men at Risk of Prostate Cancer Scheduled for an Initial Prostate Biopsy
The primary objective of the PHSTT-01 trial is to determine if prostate HistoScanning (HS) analysis can be used to improve the detection of clinically significant prostate cancer (PCa), and potentially reduce the burden and number of biopsies in routine clinical practice. Prostate HS is an ultrasound-based tissue characterization technology specifically developed to detect, visualize, and locate tissue suspected of harboring PCa. These suspicious tissues are displayed as red areas on an imaging monitor. Recently a new biopsy guidance tool has been developed that uses the results of the prostate HS analysis.
The subjects that will participate in this study are all scheduled for a first biopsy of the prostate. They will initially be imaged using transrectal ultrasound (TRUS) to obtain data for prostate HS analysis. The results of HS analysis will be used later in the procedure. Subjects will then undergo a routine systematic 10- to 12-core biopsy procedure using TRUS. This will be followed by a TRUS-guided biopsy that uses the result of prostate HS analysis and new biopsy guidance tool.
Read the detailed description
PHSTT-01 is a multi-center, prospective clinical trial to evaluate the diagnostic performance of prostate HistoScanning (HS) analysis in men at risk of PCa that have been scheduled for a first prostate biopsy. The purpose of this study is to determine if prostate HS analysis can improve the detection of clinically significant PCa, and potentially reduce the burden and number of biopsies in routine clinical practice. Subjects are men with serum total prostate-specific antigen (PCA) <= 20ng/mL (<= 10ng/mL if taking the 5-alpha reductase inhibitor).
In a single visit, subjects will first be imaged with TRUS for the purpose of generating data for prostate HS analysis. The results of HS analysis will be used later in the procedure. Subjects will then undergo two consecutive biopsy procedures. First, using TRUS, a systematic 10- to 12-core biopsy procedure will be performed. In turn, prostate HS data taken at the beginning of the procedure will be used to determine suspicious areas (displayed as red on an imaging monitor) and used to guide the biopsy procedure. Areas that are identified as suspicious (zero to a maximum of 3 areas) will then be sampled with two biopsy cores. Depending on the number of suspicious areas identified by prostate HS, the number of cores will be zero to a maximum of 6 cores.
- Conditions
- Prostate Cancer
- Being tested
- Prostate HistoScanning
- Keywords
- HistoScanning, TRUS, Prostate cancer, Biopsy guidance
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate HistoScanningDevice
Also called PHS/PHS TT
In a single visit, subjects will first be imaged with TRUS for the purpose of generating data for prostate HS analysis. The results of HS analysis will be used later in the procedure. Subjects will then undergo two consecutive biopsy procedures. First, using TRUS, a systematic 10- to 12-core biopsy procedure will be performed. In turn, prostate HS data taken at the beginning of the procedure will be used to determine suspicious areas (displayed as red on an imaging monitor) and used to guide the biopsy procedure. Areas that are identified as suspicious (zero to a maximum of 3 areas) will then be sampled with two biopsy cores. Depending on the number of suspicious areas identified by prostate HS, the number of cores will be zero to a maximum of 6 cores.
| Study group | Role | What they receive |
|---|---|---|
| single arm study | Other | Prostate HistoScanning (HS) analysis with HS-guided biopsy will be used to sample two cores per suspicious area (displayed as red on an imaging monitor), up to a maximum of 3 suspicious areas per subject. Depending on the number of suspicious areas identified by prostate HS, the number of cores will be zero (if no suspicious area is identified) up to a maximum of 6 cores. Receives: Device: Prostate HistoScanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of prostate HistoScanning (HS) to identify clinically significant PCa using histology outcomes from systematic prostate biopsy (Bx) as reference
Compare prostate HS results to the systematic Bx outcome (positive or negative) for clinically significant PCa (defined as Gleason sum ≥ 7) in the non-run-in population.
Measured: 1 year
Secondary outcomes (3)
Diagnostic performance of prostate HS to identify PCa using histology outcomes from systematic Bx as reference
Compare prostate HS results to the systematic Bx outcome (positive or negative) for all PCa in the non-run-in population.
Measured: 1 year
Diagnostic performance of prostate HS to identify clinically significant PCa using a combination of outcomes of both systematic Bx and HS-guided biopsy histology as reference
Compare prostate HS results to the combination of systematic and HS-guided Bx outcomes (positive or negative) for clinically significant PCa (defined as Gleason sum ≥ 7) in the non-run-in population.
Measured: 1 year
Difference in detection rates of clinically significant PCa between systematic and HS-guided biopsy.
Compared PCa detection rates of systematic and HS-guided prostate Bx in the non-run-in population.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Sponsor is bankrupt
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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Medical Diagnostics s.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bertrand Tombal, Prof, Principal investigator, Cliniques Universitaires Saint-Luc, Brussels, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950871
- Sponsor's protocol ID
- CR2P01127
- Other IDs
- DRKS00005263
- Acronym
- PHSTT-01
- Status last verified
- Jan 2015
- First submitted
- 19 Sep 2013
- Last updated
- 5 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Prostate HistoScanningTM (PHS) in Men at Risk of Prostate Cancer Scheduled for an Initial Prostate Biopsy
- ClinicalTrials.gov ID
- NCT01950871
- Acronym / sponsor ID
- PHSTT-01 / CR2P01127
- Conditions
- Prostate Cancer
- Keywords
- HistoScanning, TRUS, Prostate cancer, Biopsy guidance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor is bankrupt
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Advanced Medical Diagnostics s.a.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 Sep 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.
The primary objective of the PHSTT-01 trial is to determine if prostate HistoScanning (HS) analysis can be used to improve the detection of clinically significant prostate cancer (PCa), and potentially reduce the burden and number of biopsies in routine clinical practice. Prostate HS is an ultrasound-based tissue characterization technology specifically developed to detect, visualize, and locate tissue suspected of harboring PCa. These suspicious tissues are displayed as red areas on an imaging monitor. Recently a new biopsy guidance tool has been developed that uses the results of the prostate HS analysis.
The subjects that will participate in this study are all scheduled for a first biopsy of the prostate. They will initially be imaged using transrectal ultrasound (TRUS) to obtain data for prostate HS analysis. The results of HS analysis will be used later in the procedure. Subjects will then undergo a routine systematic 10- to 12-core biopsy procedure using TRUS. This will be followed by a TRUS-guided biopsy that uses the result of prostate HS analysis and new biopsy guidance tool.
Detailed description
PHSTT-01 is a multi-center, prospective clinical trial to evaluate the diagnostic performance of prostate HistoScanning (HS) analysis in men at risk of PCa that have been scheduled for a first prostate biopsy. The purpose of this study is to determine if prostate HS analysis can improve the detection of clinically significant PCa, and potentially reduce the burden and number of biopsies in routine clinical practice. Subjects are men with serum total prostate-specific antigen (PCA) <= 20ng/mL (<= 10ng/mL if taking the 5-alpha reductase inhibitor).
In a single visit, subjects will first be imaged with TRUS for the purpose of generating data for prostate HS analysis. The results of HS analysis will be used later in the procedure. Subjects will then undergo two consecutive biopsy procedures. First, using TRUS, a systematic 10- to 12-core biopsy procedure will be performed. In turn, prostate HS data taken at the beginning of the procedure will be used to determine suspicious areas (displayed as red on an imaging monitor) and used to guide the biopsy procedure. Areas that are identified as suspicious (zero to a maximum of 3 areas) will then be sampled with two biopsy cores. Depending on the number of suspicious areas identified by prostate HS, the number of cores will be zero to a maximum of 6 cores.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm study | Other | Device: Prostate HistoScanningProstate HistoScanning (HS) analysis with HS-guided biopsy will be used to sample two cores per suspicious area (displayed as red on an imaging monitor), up to a maximum of 3 suspicious areas per subject. Depending on the number of suspicious areas identified by prostate HS, the number of cores will be zero (if no suspicious area is identified) up to a maximum of 6 cores. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men at risk of PCa scheduled for first biopsy with serum total PSA
- ≤ 20 ng/ml (≤ 10 ng/mL if taking 5-alpha reductase inhibitors) from maximally 3 months ago
- Signed informed consent
Key exclusion criteria (7 listed)
- Previous prostate biopsy
- Confirmed PCa
- PSA > 20 ng/ml (or > 10 ng/mL if taking 5-alpha reductase inhibitors)
- Active urinary tract infection
- Presence/history of any confirmed cancer
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 |
|---|---|---|
| Prostate HistoScanningAlso: PHS/PHS TTIn a single visit, subjects will first be imaged with TRUS for the purpose of generating data for prostate HS analysis. The results of HS analysis will be used later in the procedure. Subjects will then undergo two consecutive biopsy procedures. First, using TRUS, a systematic 10- to 12-core biopsy procedure will be performed. In turn, prostate HS data taken at the beginning of the procedure will be used to determine suspicious areas (displayed as red on an imaging monitor) and used to guide the biopsy procedure. Areas that are identified as suspicious (zero to a maximum of 3 areas) will then be sampled with two biopsy cores. Depending on the number of suspicious areas identified by prostate HS, the number of cores will be zero to a maximum of 6 cores. | Device | single arm study |
Primary outcome
Diagnostic performance of prostate HistoScanning (HS) to identify clinically significant PCa using histology outcomes from systematic prostate biopsy (Bx) as reference
Time frame: 1 year
Compare prostate HS results to the systematic Bx outcome (positive or negative) for clinically significant PCa (defined as Gleason sum ≥ 7) in the non-run-in population.
3 secondary outcomes
Diagnostic performance of prostate HS to identify PCa using histology outcomes from systematic Bx as reference
Time frame: 1 year
Diagnostic performance of prostate HS to identify clinically significant PCa using a combination of outcomes of both systematic Bx and HS-guided biopsy histology as reference
Time frame: 1 year
Difference in detection rates of clinically significant PCa between systematic and HS-guided biopsy.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Sponsor is bankrupt). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
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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.
Bertrand Tombal, Prof principal investigator
Cliniques Universitaires Saint-Luc, Brussels, Belgium
34 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prostate HistoScanning in people with Prostate Cancer, run by Advanced Medical Diagnostics s.a. at 34 sites in 18 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 3 inclusion and 7 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 5 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Germany, Austria, Belgium, United Kingdom, Czechia and 13 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: Sponsor is bankrupt). 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?
Diagnostic performance of prostate HistoScanning (HS) to identify clinically significant PCa using histology outcomes from systematic prostate biopsy (Bx) as reference (time frame: 1 year). 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 5 Jan 2015.