Prostate CancerPhase 2/3TePSMAG-68NCT03344822
Place of 68Ga-PSMA-11 PET-CT in the Therapeutic Decision at the End of the Initial Staging for High Risk Prostate Cancer Patients
A Phase 2/3 study testing 68Ga-PSMA-11 and 18F-Choline PET-CT in people with Prostate Cancer, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Several studies have shown a great potential of 68Ga-PSMA PET in high risk prostate cancers patients and a high detection rate than 18F-Choline PET. The primary aim of this study is to evaluate the difference of management intent, after the inital staging of high risk prostate cancer patients, with 68Ga-PSMA-11 PET-CT… 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?
- 68Ga-PSMA-11 and 18F-Choline PET-CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2018to 31 Dec 2019
- Phase
- Phase 2/3
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- high risk prostate cancer patients with initial tests : CT, bone scintigraphy and 18F-Choline
Who cannot join
- contraindication of 68Ga-PSMA PET-CT
Trial locations and contacts
1 site in 1 country.
France1 site
Central hospital Nancy
Nancy, 54000
Marine Claudin, Doctor, m.claudin@chru-nancy.fr
Pierre Olivier, Professor
About this study
Official title: Place of 68Ga-PSMA-11 PET-CT in the Therapeutic Decision at the End of the Initial Staging for High Risk Prostate Cancer Patients in Comparaison of 18F-Choline PET-CT
Several studies have shown a great potential of 68Ga-PSMA PET in high risk prostate cancers patients and a high detection rate than 18F-Choline PET.
The primary aim of this study is to evaluate the difference of management intent, after the inital staging of high risk prostate cancer patients, with 68Ga-PSMA-11 PET-CT results in comparison of 18F-Choline PET-CT results.
- Conditions
- Prostate Cancer
- Being tested
- 68Ga-PSMA-11, 18F-Choline PET-CT
- Keywords
- 68Ga-PSMA PET
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-PSMA-11Diagnostic test
radioactive tracer for PET-CT (68Ga-PSMA-11)
18F-Choline PET-CTDiagnostic test
radioactive tracer for PET-CT (18F-Choline PET-CT)
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-PSMA PET-CT | Experimental | Not described Receives: Diagnostic Test: 68Ga-PSMA-11; Diagnostic Test: 18F-Choline PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of modification of management intent
modification of management intent after 68Ga-PSMA PET-CT and 18F-Choline PET-CT
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start2 Jan 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
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 Central Hospital, Nancy, FranceThe 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each patient will realize a 18F-Choline PET/CT then a 68Ga-PSMA-11 PET/CT
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344822
- Sponsor's protocol ID
- PSS2016/TePSMAG-68-CLAUDIN/VS
- Acronym
- TePSMAG-68
- Status last verified
- Nov 2017
- First submitted
- 14 Nov 2017
- Last updated
- 17 Nov 2017
- 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 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Place of 68Ga-PSMA-11 PET-CT in the Therapeutic Decision at the End of the Initial Staging for High Risk Prostate Cancer Patients in Comparaison of 18F-Choline PET-CT
- ClinicalTrials.gov ID
- NCT03344822
- Acronym / sponsor ID
- TePSMAG-68 / PSS2016/TePSMAG-68-CLAUDIN/VS
- Conditions
- Prostate Cancer
- Keywords
- 68Ga-PSMA PET
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 2 Jan 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 17 Nov 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.
Several studies have shown a great potential of 68Ga-PSMA PET in high risk prostate cancers patients and a high detection rate than 18F-Choline PET.
The primary aim of this study is to evaluate the difference of management intent, after the inital staging of high risk prostate cancer patients, with 68Ga-PSMA-11 PET-CT results in comparison of 18F-Choline PET-CT results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each patient will realize a 18F-Choline PET/CT then a 68Ga-PSMA-11 PET/CT
| Arm | Type | Receives |
|---|---|---|
| 68Ga-PSMA PET-CT | Experimental | Diagnostic Test: 68Ga-PSMA-11, Diagnostic Test: 18F-Choline PET-CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- high risk prostate cancer patients with initial tests : CT, bone scintigraphy and 18F-Choline
Key exclusion criteria (1 listed)
- contraindication of 68Ga-PSMA PET-CT
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 |
|---|---|---|
| 68Ga-PSMA-11radioactive tracer for PET-CT (68Ga-PSMA-11) | Diagnostic test | 68Ga-PSMA PET-CT |
| 18F-Choline PET-CTradioactive tracer for PET-CT (18F-Choline PET-CT) | Diagnostic test | 68Ga-PSMA PET-CT |
Primary outcome
percentage of modification of management intent
Time frame: 1 month
modification of management intent after 68Ga-PSMA PET-CT and 18F-Choline PET-CT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 68Ga-PSMA-11 and 18F-Choline PET-CT in people with Prostate Cancer, run by Central Hospital, Nancy, France at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Nov 2017. 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 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of modification of management intent (time frame: 1 month). 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 Nov 2017.