Cancer ProstateBio-ProstNCT03157856
Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection
An observational study of Cancer Prostate, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
In this study, we aim to evaluate the feasibility of anti-PSMA labelling to detect post-operative prostatic tissues by two ex vivo fluorescence techniques. We will evaluate the feasibility and detection of anti-PSMA labelling by: 1. / the FEMTO-ST institute medical device, 2. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cancer Prostate
- What is being tested?
- Fluorescence assessment
- How many people
- 8 participants
- Where
- 2 sitesFrance
- Study dates
- 11 May 2017to 8 Jan 2019
- Phase
- Observational
- 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
Study population: Patient with indication for radical prostatectomy
Who may be able to join
- male patient over 18 years old
- patient with indication for radical prostatectomy
- patient with a rectal palpable nodule or targeted MRI positive biopsies or with at least 4 positive biopsies in a hemi-prostate.
- patient affiliated to French social security system or equivalent
- patient who have signed a non-opposition form
Who cannot join
- patient with contraindication to radical prostatectomy
- patient with remedial prostatectomy
- patient with normal preoperative MRI or with absence of tumoral area
- patient with history of hormonal therapy
- person deprived of freedom by judicial or administrative decision
- person under legal protection
- person hospitalized for psychiatric care.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Grenoble Alpes University Hospital - Urology department
Grenoble, 38043
Grenoble Alpes University Hospital
Grenoble, 38043
About this study
In this study, we aim to evaluate the feasibility of anti-PSMA labelling to detect post-operative prostatic tissues by two ex vivo fluorescence techniques. We will evaluate the feasibility and detection of anti-PSMA labelling by:
- / the FEMTO-ST institute medical device,
- / the confocal microscope that will be used to measure fluorescence spectra of biological samples.
Read the detailed description
For this protocol, 12 patients will be included.
- Conditions
- Cancer Prostate
- Being tested
- Fluorescence assessment
- Keywords
- Fluorescence imaging technique, Biopsies from resected prostate, Medical device
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence assessmentOther
All subjects of the study are going to have a radical prostatectomy. The FEMTO-ST medical device is used on 3 fresh biopsies (2 healthy and 1 malignant) which will be prelevated from the resected prostate in order to determine the prostatic or non-prostatic nature of tissue.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: fluorescence assessment | Medical device: Use of the FEMTO-ST institute medical device to detect prostatic and non prostatic tissue. Receives: Other: Fluorescence assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for prostatic and non-prostatic tissue, as identified by anatomo-pathology (gold standard).
Fluorescence measurements obtained using the FEMTO-ST medical device and the confocal microscope.
Measured: 14 months
Secondary outcomes (1)
Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for cancerous and non-cancerous tissue, as identified by anatomo-pathology (gold standard).
Fluorescence measurements obtained using the FEMTO-ST medical device and the confocal microscope.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start11 May 2017
- Primary completion7 Oct 2018
- Study completion8 Jan 2019
Why it stopped: Results obtained on the first 8 patients shown an expected glandular membrane specific labeling associated with non-specific labeling of fibro-muscular tissue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ProstateStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- TIMC-IMAG, Clinical Investigation Centre for Innovative Technology Network
- Responsible party
- Sponsor
- Investigators
- Jean Luc Descotes, MD, PhD, Principal investigator, Grenoble Alpes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157856
- Sponsor's protocol ID
- 38RC17.019
- Acronym
- Bio-Prost
- Status last verified
- Jan 2019
- First submitted
- 15 May 2017
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection
- ClinicalTrials.gov ID
- NCT03157856
- Acronym / sponsor ID
- Bio-Prost / 38RC17.019
- Conditions
- Cancer Prostate
- Keywords
- Fluorescence imaging technique, Biopsies from resected prostate, Medical device
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Results obtained on the first 8 patients shown an expected glandular membrane specific labeling associated with non-specific labeling of fibro-muscular tissue.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- TIMC-IMAG, Clinical Investigation Centre for Innovative Technology Network
- Study start
- 11 May 2017 (actual)
- Primary completion
- 7 Oct 2018 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 17 May 2017 (actual)
- 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.
In this study, we aim to evaluate the feasibility of anti-PSMA labelling to detect post-operative prostatic tissues by two ex vivo fluorescence techniques. We will evaluate the feasibility and detection of anti-PSMA labelling by:
- / the FEMTO-ST institute medical device,
- / the confocal microscope that will be used to measure fluorescence spectra of biological samples.
Detailed description
For this protocol, 12 patients will be included.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: fluorescence assessment | – | Other: Fluorescence assessmentMedical device: Use of the FEMTO-ST institute medical device to detect prostatic and non prostatic tissue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with indication for radical prostatectomy
Key inclusion criteria (5 listed)
- male patient over 18 years old
- patient with indication for radical prostatectomy
- patient with a rectal palpable nodule or targeted MRI positive biopsies or with at least 4 positive biopsies in a hemi-prostate.
Key exclusion criteria (7 listed)
- patient with contraindication to radical prostatectomy
- patient with remedial prostatectomy
- patient with normal preoperative MRI or with absence of tumoral area
- patient with history of hormonal therapy
- person deprived of freedom by judicial or administrative decision
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 |
|---|---|---|
| Fluorescence assessmentAll subjects of the study are going to have a radical prostatectomy. The FEMTO-ST medical device is used on 3 fresh biopsies (2 healthy and 1 malignant) which will be prelevated from the resected prostate in order to determine the prostatic or non-prostatic nature of tissue. | Other | Experimental: fluorescence assessment |
Primary outcome
Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for prostatic and non-prostatic tissue, as identified by anatomo-pathology (gold standard).
Time frame: 14 months
Fluorescence measurements obtained using the FEMTO-ST medical device and the confocal microscope.
1 secondary outcome
Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for cancerous and non-cancerous tissue, as identified by anatomo-pathology (gold standard).
Time frame: 14 months
Results and safety
The study was stopped early (reason given: Results obtained on the first 8 patients shown an expected glandular membrane specific labeling associated with non-specific labeling of fibro-muscular tissue.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Jean Luc Descotes, MD, PhD principal investigator
Grenoble Alpes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Prostate, run by University Hospital, Grenoble at 2 sites in France.
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 5 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 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 was stopped early (reason given: Results obtained on the first 8 patients shown an expected glandular membrane specific labeling associated with non-specific labeling of fibro-muscular tissue.). 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?
Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for prostatic and non-prostatic tissue, as identified by anatomo-pathology (gold standard). (time frame: 14 months). 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 15 Jan 2019.