Prostate CancerPhase 3TEPGALCHOLNCT03623425
Comparison of PET With 68GA-PSMA-11 and 18F-Fluorocholine for Recurrence in Men With Prostate Cancer
A Phase 3 study testing 68Ga-PSMA-11 PET and 18F-FCH PET in people with Prostate Cancer, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
As choline transport and phosphorylation are upregulated in most cancers, including prostate cancer, positron emission tomography (PET) with choline tracers has found widespread use to detect recurrent disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 68Ga-PSMA-11 PET and 18F-FCH PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2019to 1 May 2020
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men ranging in age from 18 to 80
- Patient who have developed prostate cancer, and underwent radical treatment by prostatectomy or radiotherapy.
- PSA<10 ng/ml at inclusion
- Rising prostate-specific antigen (PSA) after curative treatment of prostate cancer (radical prostatectomy or radiation therapy). Following definitions will apply:
- Biochemical recurrence =
- After surgery: two sequential PSA values >0.2 ng/ml
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- After radiation therapy: PSA increased by 2 ng/ml above nadir value
- Residual disease =
- After surgery: positive PSA immediately after surgery or positive surgical margin
- After radiation therapy: two sequential PSA >0.2 ng/ml (to avoid false positive)
- Progressive disease =
- PSA doubling time ≤ 6 months irrespective of initial PSA value
- Patients with a positron emission tomography with 18F-Fluorocholine (PET 18F-Fcholine) requested, as part of routine care.
- Estimated life-expectancy > 6 months
- Patients able to come for PET exams
- Patients affiliated to or beneficiary of a social security plan
- Patients physically and psychologically able to participate to the study
- Person informed about study organization and having signed the informed consent
- Patients who understood the principle and modalities of the study
- Person undergone the medical examination adapted to research
Who cannot join
- Known hypersensitivity to the active substance or to any excipient of the IMP
- Patients with known allergy to furosemide or sulfonamides. Other contraindications to furosemide do not apply to patients for whom the product will be used as a single dose
- Patients with a history of malignant pathology (except for basal-cell cutaneous carcinoma)
- Drug or alcohol dependence, serious current illness, mental disorder or any circumstance which, in the opinion of the investigator, could interfere with the conduct or interpretation of the study
- Exposure to another IMP within 60 days prior to inclusion
- Person referred in articles L.1121-7 and L.1121-8 of the Public Health Code:
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- Minor person (non-emancipated)
- Adult person under legal protection (any form of public guardianship)
- Adult person incapable of giving consent
- Person deprived of liberty for judicial or administrative decision, Person under psychiatric care according to articles L. 3212-1 and L. 3213-1.
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU de NANCY- BRABOIS
Vandœuvre-lès-Nancy, 54511
Pierre OLIVIER, MD, PhD, + 33 3 83 15 39 11, p.olivier@chru-nancy.fr
Véronique ROCH, MSc, +33 3 83 15 42 76, v.roch@chru-nancy.fr
About this study
Official title: Comparison of PET Imaging With 68GA-PSMA-11 and 18F-Fluorocholine for the Identification of Site of Recurrence in Men With Prostate Cancer
As choline transport and phosphorylation are upregulated in most cancers, including prostate cancer, positron emission tomography (PET) with choline tracers has found widespread use to detect recurrent disease. However, choline metabolism is not increased in a significant number of cases, probably explaining why this imaging method has been reported to be weakly sensitive and specific fro the detection of prostate cancer lesions, especially at low prostate-specific antigen (PSA) levels. By contrast, prostate-specific membrane antigen (PSMA) is overexpressed in most prostate cancer, suggesting that 68Ga-labelled PSMA ligands could be superior to choline tracers. A meta-analysis published in 2016 (Perera M. and al.), which included 18 studies, of which five reported histolopathologic correlation data for 68Ga-PSMA PET-positive lesions, indicated favourable sensitivity and specificity profiles of 68Ga-labelled PSMA ligands compared to choline-based PET imaging techniques.
Read the detailed description
HBED-PSMA Sterile Cold Kit is a kit for preparation of radiolabelled 68Ga-PSMA-11. After radiolabelling with a 68Ga chloride solution complying with the requirements of monograph 2464 of the European Pharmacopoeia (Ph Eur), the solution may be used in men with biochemical relapse of prostate cancer after treatment. A large number of studies have been published on 68Ga-PSMA-ligands but none has yet been conducted with a product manufactured in accordance with ANMI technology. The aim of the study is to demonstrate the superiority of 68Ga-PSMA-11, prepared from a room temperature radiolabel kit containing PSMA-11 (PSMA-11 Sterile Cold Kit) and gallium 68 obtained from a 68Ge / 68Ga generator on 18F-Fluorocholine (18F-FCH) in identifying prostate cancer recurrence after radical treatment sites. So, patients will be evaluated with the current workup at CHRU of Nancy and will then be submitted to 68GA-PSMA-11 and 18F-FCH imaging. Patients will be randomized to the imaging procedure after workup in a 1/1 ratio between 68GA-PSMA-11 and comparator. So all patients will be submitted to 68GA-PSMA-11 and 18F-FCH; 50% of patients will receive the 68GA-PSMA-11 first; 50% of patients will receive the comparator first. There will be a time interval of minimum 7 days and maximum 14 days between both imaging procedures.
In order to mimic, as far as possible, the routine clinical practices, a sequential unblinding will be used for image readers. Readers will evaluate 68GA-PSMA-11 and 18F-FCH images with progressive access to more clinical information on each read. It will be done in three steps: fully blinded image evaluation, then image evaluation with results of the patient's clinical history and finally image evaluation with results of the patient's workup and clinical history.
- Conditions
- Prostate Cancer
- Being tested
- 68Ga-PSMA-11 PET, 18F-FCH 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-11 PETDrug
a 68GA-PSMA-11 PET exam before the a 18F-FCH PET exam
18F-FCH PETDrug
a 18F-FCH PET exam before the 68Ga-PSMA-11 PET exam
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-PSMA-11 PET before 18F-FCH PET | Experimental | Crossover design Receives: Drug: 68Ga-PSMA-11 PET; Drug: 18F-FCH PET |
| 18F-FCH PET before 68Ga-PSMA-11 PET | Experimental | Crossover design Receives: Drug: 68Ga-PSMA-11 PET; Drug: 18F-FCH PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of lesions characteristic for prostate cancer detected by each TEP imaging method, by 68Ga-PSMA-11 and 18F-Fluorocholine
An experts committee will conduct a confirmatory assessment of all lesions three months after the last PET scan for each patient..
Measured: three months after the last PET exam for each patient
Secondary outcomes (4)
Count and characterize prostate cancer lesions for each method
Detection rate and Standardized Uptake Value (SUV) and tumor to background ratio (TBR)
Measured: three months after the last PET exam for each patient
Number of patients whose diagnosis and/or treatment are impacted by the results of the imaging procedures
Compare diagnoses and treatments decided with and without PET results
Measured: three months after the last PET exam for each patient
Sensitivity, specificity and predictive values of each tomography method
+ 95% CI
Measured: three months after the last PET exam for each patient
Number of adverse events and serious adverse events, whether or not related to research
Description of adverse events, incidence, severity, outcome and causality
Measured: three months after the last PET exam for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Feb 2019 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2020 (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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Phase III, open, single center, prospective, controlled and randomized crossover study comparing diagnostic performance of 68GA-PSMA-11 and 18F-Fluorocholine. 68GA-PSMA-11 PET and 18F-Fluorocholine PET interpretation will be done by different nuclear physicians.
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- GIE NANCYCLOTEP, Advanced Nuclear Medicine Ingredients (ANMI)
- Responsible party
- Sponsor
- Investigators
- Pierre OLIVIER, MD, PhD, Principal investigator, CHRU de NANCY- BRABOIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623425
- Sponsor's protocol ID
- 2017-003620-69
- Other IDs
- PSS2017/ANMI-OLIVIER/VS, 2017
- Acronym
- TEPGALCHOL
- Status last verified
- Jul 2018
- First submitted
- 6 Aug 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of PET Imaging With 68GA-PSMA-11 and 18F-Fluorocholine for the Identification of Site of Recurrence in Men With Prostate Cancer
- ClinicalTrials.gov ID
- NCT03623425
- Acronym / sponsor ID
- TEPGALCHOL / 2017-003620-69
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- GIE NANCYCLOTEP, Advanced Nuclear Medicine Ingredients (ANMI)
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 9 Aug 2018 (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.
As choline transport and phosphorylation are upregulated in most cancers, including prostate cancer, positron emission tomography (PET) with choline tracers has found widespread use to detect recurrent disease. However, choline metabolism is not increased in a significant number of cases, probably explaining why this imaging method has been reported to be weakly sensitive and specific fro the detection of prostate cancer lesions, especially at low prostate-specific antigen (PSA) levels. By contrast, prostate-specific membrane antigen (PSMA) is overexpressed in most prostate cancer, suggesting that 68Ga-labelled PSMA ligands could be superior to choline tracers. A meta-analysis published in 2016 (Perera M. and al.), which included 18 studies, of which five reported histolopathologic correlation data for 68Ga-PSMA PET-positive lesions, indicated favourable sensitivity and specificity profiles of 68Ga-labelled PSMA ligands compared to choline-based PET imaging techniques.
Detailed description
HBED-PSMA Sterile Cold Kit is a kit for preparation of radiolabelled 68Ga-PSMA-11. After radiolabelling with a 68Ga chloride solution complying with the requirements of monograph 2464 of the European Pharmacopoeia (Ph Eur), the solution may be used in men with biochemical relapse of prostate cancer after treatment. A large number of studies have been published on 68Ga-PSMA-ligands but none has yet been conducted with a product manufactured in accordance with ANMI technology. The aim of the study is to demonstrate the superiority of 68Ga-PSMA-11, prepared from a room temperature radiolabel kit containing PSMA-11 (PSMA-11 Sterile Cold Kit) and gallium 68 obtained from a 68Ge / 68Ga generator on 18F-Fluorocholine (18F-FCH) in identifying prostate cancer recurrence after radical treatment sites. So, patients will be evaluated with the current workup at CHRU of Nancy and will then be submitted to 68GA-PSMA-11 and 18F-FCH imaging. Patients will be randomized to the imaging procedure after workup in a 1/1 ratio between 68GA-PSMA-11 and comparator. So all patients will be submitted to 68GA-PSMA-11 and 18F-FCH; 50% of patients will receive the 68GA-PSMA-11 first; 50% of patients will receive the comparator first. There will be a time interval of minimum 7 days and maximum 14 days between both imaging procedures.
In order to mimic, as far as possible, the routine clinical practices, a sequential unblinding will be used for image readers. Readers will evaluate 68GA-PSMA-11 and 18F-FCH images with progressive access to more clinical information on each read. It will be done in three steps: fully blinded image evaluation, then image evaluation with results of the patient's clinical history and finally image evaluation with results of the patient's workup and clinical history.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase III, open, single center, prospective, controlled and randomized crossover study comparing diagnostic performance of 68GA-PSMA-11 and 18F-Fluorocholine. 68GA-PSMA-11 PET and 18F-Fluorocholine PET interpretation will be done by different nuclear physicians.
| Arm | Type | Receives |
|---|---|---|
| 68Ga-PSMA-11 PET before 18F-FCH PET | Experimental | Drug: 68Ga-PSMA-11 PET, Drug: 18F-FCH PETCrossover design |
| 18F-FCH PET before 68Ga-PSMA-11 PET | Experimental | Drug: 68Ga-PSMA-11 PET, Drug: 18F-FCH PETCrossover design |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Adult men ranging in age from 18 to 80
- Patient who have developed prostate cancer, and underwent radical treatment by prostatectomy or radiotherapy.
- PSA<10 ng/ml at inclusion
- Rising prostate-specific antigen (PSA) after curative treatment of prostate cancer (radical prostatectomy or radiation therapy). Following definitions will apply:
- Patients with a positron emission tomography with 18F-Fluorocholine (PET 18F-Fcholine) requested, as part of routine care.
Key exclusion criteria (10 listed)
- Known hypersensitivity to the active substance or to any excipient of the IMP
- Patients with known allergy to furosemide or sulfonamides. Other contraindications to furosemide do not apply to patients for whom the product will be used as a single dose
- Patients with a history of malignant pathology (except for basal-cell cutaneous carcinoma)
- Drug or alcohol dependence, serious current illness, mental disorder or any circumstance which, in the opinion of the investigator, could interfere with the conduct or interpretation of the study
- Exposure to another IMP within 60 days prior to inclusion
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-11 PETa 68GA-PSMA-11 PET exam before the a 18F-FCH PET exam | Drug | 18F-FCH PET before 68Ga-PSMA-11 PET, 68Ga-PSMA-11 PET before 18F-FCH PET |
| 18F-FCH PETa 18F-FCH PET exam before the 68Ga-PSMA-11 PET exam | Drug | 18F-FCH PET before 68Ga-PSMA-11 PET, 68Ga-PSMA-11 PET before 18F-FCH PET |
Primary outcome
Number of lesions characteristic for prostate cancer detected by each TEP imaging method, by 68Ga-PSMA-11 and 18F-Fluorocholine
Time frame: three months after the last PET exam for each patient
An experts committee will conduct a confirmatory assessment of all lesions three months after the last PET scan for each patient..
4 secondary outcomes
Count and characterize prostate cancer lesions for each method
Time frame: three months after the last PET exam for each patient
Number of patients whose diagnosis and/or treatment are impacted by the results of the imaging procedures
Time frame: three months after the last PET exam for each patient
Sensitivity, specificity and predictive values of each tomography method
Time frame: three months after the last PET exam for each patient
Number of adverse events and serious adverse events, whether or not related to research
Time frame: three months after the last PET exam for each patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
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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.
Pierre OLIVIER, MD, PhD principal investigator
CHRU de NANCY- BRABOIS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 68Ga-PSMA-11 PET and 18F-FCH PET 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 20 inclusion and 10 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 9 Aug 2018. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre OLIVIER, MD, PhD (+ 33 3 83 15 39 11, p.olivier@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of lesions characteristic for prostate cancer detected by each TEP imaging method, by 68Ga-PSMA-11 and 18F-Fluorocholine (time frame: three months after the last PET exam for each patient). 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 9 Aug 2018.