Prostate Cancer RecurrentPSMA REBIOLOCNCT03443609
Study of 68Ga-HBED-PSMA PET/CT and Conventional Imaging in Occult Biological Relapse Prostate Cancer
A study testing 68Ga-HBED-CC-PSMA PET / CT in people with Prostate Cancer Recurrent, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
68Ga-HBED-CC-PSMA is a radiopharmaceutical allowing a new imaging modality for the detection of prostate cancer recurrences, used in recent years in clinical studies by some teams mainly in Europe (1-6 ). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Recurrent
- What is being tested?
- 68Ga-HBED-CC-PSMA PET / CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2017to 29 Sep 2019
- Phase
- Interventional
- 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
- Age above 18 years
- Diagnosis of histologically proven prostate cancer.
- Patient having benefited from previous curative treatment (prostatectomy, radiotherapy, ultrasound, cryotherapy ...), with a significant decrease in the plasma concentration of PSA at the end of treatment (= indisputable PSA)
- Biologic recurrence documented by abnormal results in 2 assays of plasma PSA concentration in the same laboratory.
- Value of the plasma concentration of the last PSA assay during the 4 months preceding D0: 0.05 ng / mL ≤ PSA <1.6 ng / mL
- Conventional imaging assessment already carried out, including at least one optimized skeleton scintigraphy with thoracoabdominopelvic TEMP / CT (or 18F-Choline TEP) and pelvic MRI (or abdominopelvic CT if contraindicated MRI) less than 6 weeks old. All of these tests must have been interpreted as "negative" or "questionable" (without "suggestive" or "suspect" aspects of malignancy) written by the imaging specialist.
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- Karnofsky ≥ 70 or ECOG 0-1
- Life expectancy of at least 6 months
- The patient has given his written consent.
- Patient affiliated to a social security scheme
Who cannot join
- Another progressive cancerous condition, except for basal cell cancers.
- Acute inflammatory condition,
- Implementation of treatment (eg chemotherapy) or change of treatment (eg hormone therapy) since skeletal scintigraphy, abdominopelvic MRI or the last serum PSA test.
- Radiotherapy, chemotherapy or other anti-tumor treatment during the 6 weeks preceding PET,
- Agitation; impossibility to hold motionless for at least 1 hour, or known claustrophobia
- Poor predictable compliance or inability to undergo medical follow-up of the test for geographical, social or psychological reasons,
- Intellectual inability to sign informed consent
- Persons deprived of liberty or guardianship (including trusteeship),
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Multicenter Phase II Study, Prospective, Comparative, of 68Ga-HBED-PSMA PET / CT and Conventional Imaging Procedures in Occult Biological Relapse Prostate Cancer
68Ga-HBED-CC-PSMA is a radiopharmaceutical allowing a new imaging modality for the detection of prostate cancer recurrences, used in recent years in clinical studies by some teams mainly in Europe (1-6 ).
The aim of this study is to study the diagnostic performance of 68Ga-HBED-PSMA PET / CT in occult recurrent carcinoma (PCa) by prospectively comparing it to the standard techniques used in this indication: optimized bone scintigraphy with double TEMP / CT systematic and abdominopelvic MRI. The therapeutic impact and tolerance of this examination will also be evaluated.
The expected results are a demonstration of the superiority of 68Ga-HBED-PSMA PET compared to the standard assessment, with a potential impact on the therapeutic management of patients
Read the detailed description
METHODOLOGY:
Phase II imaging study, prospective, multicenter non-randomized.
MAIN OBJECTIVE:
To determine the added value of 68Ga-HBED-CC-PSMA PET / CT in imaging investigations in terms of the sensitivity of detection of biologic suspected prostate cancer recurrence site locations on the elevation of plasma PSA, while all conventional imaging exams are negative or questionable ("occult recurrence")
SECONDARY OBJECTIVE:
- Evaluate the clinical impact of 68Ga-HBED-CC-PSMA PET / CT in imaging exam by the predicted rate of change in therapeutic attitude.
- Evaluate the relevance of decisions made after PET / CT 68Ga-HBED-CC-PSMA.
- Determine the added value of 68Ga-HBED-CC-PSMA PET / CT in terms of specificity and predictive value for detecting secondary locations. This determination will be at the "patient" level and at the "lesion" level
- To determine the added value of the 2nd PET / CT at 68Ga-HBED-CC-PSMA (2h after the radiopharmaceutical injection) in terms of specificity and predictive value for the detection of secondary locations in relation to the added value of the 1st PET / CT acquisition at 68Ga-HBED-CC-PSMA. This determination will be at the "patient" level and at the "lesion" level.
- Confirm the perfect tolerance of 68Ga-HBED-CC-PSMA.
STUDY PROCEDURE :
All the imaging sequences will be done in an outpatient setting. There will be no premedication or other treatment before and after 68Ga-HBED-CC-PSMA PET scans. PET / CT will be performed at participating centers on a hybrid PET camera.
68Ga-HBED-CC-PSMA will be administered to the patient by single intravenous injection (Y-infused with isotonic saline infusion) within 60 min of reconstitution of the radiopharmaceutical.
The first TEP 68Ga-HBED-CC-PSMA whole body acquisition starts 60 min after the injection of 150 MBq of 68Ga-HBED-CC-PSMA and continues for 20-30 minutes, the second full-body acquisition of the same duration takes place 120 minutes after the injection is a total duration of 1 hour of imaging and 2:30 to 3:00 in the service.
- Conditions
- Prostate Cancer Recurrent
- Being tested
- 68Ga-HBED-CC-PSMA PET / CT
- Keywords
- occult prostate cancer recurrence, PSA, 68Ga-HBED-CC-PSMA PET / CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-HBED-CC-PSMA PET / CTDiagnostic test
Patient will receive a specific PET / CT with PSMA
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-HBED-CC-PSMA PET / CT | Other | Patients will receive 68Ga-HBED-CC-PSMA PET / CT imaging for the detection of prostate cancer recurrence sites. This determination will be made at the "patient" and "lesion" level by reference to the gold standard (or truth standard) that will be obtained from the histology data and / or from an imaging and evolution follow-up. PSA over a period of at least 6 months (RECIST 1.1 criteria). Receives: Diagnostic Test: 68Ga-HBED-CC-PSMA PET / CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
added value of 68Ga-HBED-CC-PSMA PET / CT in imaging examinations in terms of detection sensitivity of recurrence sites
To determine the added value of 68Ga-HBED-CC-PSMA PET / CT in imaging examinations in terms of detection sensitivity of prostate cancer recurrence sites, biologically suspected of elevated plasma concentrations of PSA, while all conventional imaging tests are negative or questionable: "occult recurrence".
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start31 Mar 2017
- Primary completion12 Dec 2018
- Study completion29 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer RecurrentStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All the imaging sequences will be done in an outpatient setting. There will be no premedication or other treatment before and after 68Ga-HBED-CC-PSMA PET scans. PET / CT will be performed at participating centers on a hybrid PET camera. 68Ga-HBED-CC-PSMA will be administered to the patient by single intravenous injection (Y-infused with isotonic saline infusion) within 60 min of reconstitution of the radiopharmaceutical. The first TEP 68Ga-HBED-CC-PSMA whole body acquisition starts 60 min after the injection of 150 MBq of 68Ga-HBED-CC-PSMA and continues for 20-30 minutes, the second full-body acquisition of the same duration takes place 120 minutes after the injection is a total duration of 1 hour of imaging and 2:30 to 3:00 in the service.
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ROUSSEAU Caroline, MD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443609
- Sponsor's protocol ID
- ICO-N-2016-01
- Acronym
- PSMA REBIOLOC
- Status last verified
- May 2021
- First submitted
- 16 Feb 2018
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rousseau C, Le Thiec M, Ferrer L, Rusu D, Rauscher A, Maucherat B, Frindel M, Baumgartner P, Fleury V, Denis A, Morel A, Varmenot N, Debeaupuis E, Campion L, Kraeber-Bodere F. Preliminary results of a 68 Ga-PSMA PET/CT prospective study in prostate cancer patients with occult recurrence: Diagnostic performance and impact on therapeutic decision-making. Prostate. 2019 Sep;79(13):1514-1522. doi: 10.1002/pros.23869. Epub 2019 Aug 17.
PubMed 31421657
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Multicenter Phase II Study, Prospective, Comparative, of 68Ga-HBED-PSMA PET / CT and Conventional Imaging Procedures in Occult Biological Relapse Prostate Cancer
- ClinicalTrials.gov ID
- NCT03443609
- Acronym / sponsor ID
- PSMA REBIOLOC / ICO-N-2016-01
- Conditions
- Prostate Cancer Recurrent
- Keywords
- occult prostate cancer recurrence, PSA, 68Ga-HBED-CC-PSMA PET / CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 29 Sep 2019 (actual)
- First posted
- 23 Feb 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.
68Ga-HBED-CC-PSMA is a radiopharmaceutical allowing a new imaging modality for the detection of prostate cancer recurrences, used in recent years in clinical studies by some teams mainly in Europe (1-6 ).
The aim of this study is to study the diagnostic performance of 68Ga-HBED-PSMA PET / CT in occult recurrent carcinoma (PCa) by prospectively comparing it to the standard techniques used in this indication: optimized bone scintigraphy with double TEMP / CT systematic and abdominopelvic MRI. The therapeutic impact and tolerance of this examination will also be evaluated.
The expected results are a demonstration of the superiority of 68Ga-HBED-PSMA PET compared to the standard assessment, with a potential impact on the therapeutic management of patients
Detailed description
METHODOLOGY:
Phase II imaging study, prospective, multicenter non-randomized.
MAIN OBJECTIVE:
To determine the added value of 68Ga-HBED-CC-PSMA PET / CT in imaging investigations in terms of the sensitivity of detection of biologic suspected prostate cancer recurrence site locations on the elevation of plasma PSA, while all conventional imaging exams are negative or questionable ("occult recurrence")
SECONDARY OBJECTIVE:
- Evaluate the clinical impact of 68Ga-HBED-CC-PSMA PET / CT in imaging exam by the predicted rate of change in therapeutic attitude.
- Evaluate the relevance of decisions made after PET / CT 68Ga-HBED-CC-PSMA.
- Determine the added value of 68Ga-HBED-CC-PSMA PET / CT in terms of specificity and predictive value for detecting secondary locations. This determination will be at the "patient" level and at the "lesion" level
- To determine the added value of the 2nd PET / CT at 68Ga-HBED-CC-PSMA (2h after the radiopharmaceutical injection) in terms of specificity and predictive value for the detection of secondary locations in relation to the added value of the 1st PET / CT acquisition at 68Ga-HBED-CC-PSMA. This determination will be at the "patient" level and at the "lesion" level.
- Confirm the perfect tolerance of 68Ga-HBED-CC-PSMA.
STUDY PROCEDURE :
All the imaging sequences will be done in an outpatient setting. There will be no premedication or other treatment before and after 68Ga-HBED-CC-PSMA PET scans. PET / CT will be performed at participating centers on a hybrid PET camera.
68Ga-HBED-CC-PSMA will be administered to the patient by single intravenous injection (Y-infused with isotonic saline infusion) within 60 min of reconstitution of the radiopharmaceutical.
The first TEP 68Ga-HBED-CC-PSMA whole body acquisition starts 60 min after the injection of 150 MBq of 68Ga-HBED-CC-PSMA and continues for 20-30 minutes, the second full-body acquisition of the same duration takes place 120 minutes after the injection is a total duration of 1 hour of imaging and 2:30 to 3:00 in the service.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All the imaging sequences will be done in an outpatient setting. There will be no premedication or other treatment before and after 68Ga-HBED-CC-PSMA PET scans. PET / CT will be performed at participating centers on a hybrid PET camera. 68Ga-HBED-CC-PSMA will be administered to the patient by single intravenous injection (Y-infused with isotonic saline infusion) within 60 min of reconstitution of the radiopharmaceutical. The first TEP 68Ga-HBED-CC-PSMA whole body acquisition starts 60 min after the injection of 150 MBq of 68Ga-HBED-CC-PSMA and continues for 20-30 minutes, the second full-body acquisition of the same duration takes place 120 minutes after the injection is a total duration of 1 hour of imaging and 2:30 to 3:00 in the service.
| Arm | Type | Receives |
|---|---|---|
| 68Ga-HBED-CC-PSMA PET / CT | Other | Diagnostic Test: 68Ga-HBED-CC-PSMA PET / CTPatients will receive 68Ga-HBED-CC-PSMA PET / CT imaging for the detection of prostate cancer recurrence sites. This determination will be made at the "patient" and "lesion" level by reference to the gold standard (or truth standard) that will be obtained from the histology data and / or from an imaging and evolution follow-up. PSA over a period of at least 6 months (RECIST 1.1 criteria). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age above 18 years
- Diagnosis of histologically proven prostate cancer.
- Patient having benefited from previous curative treatment (prostatectomy, radiotherapy, ultrasound, cryotherapy ...), with a significant decrease in the plasma concentration of PSA at the end of treatment (= indisputable PSA)
- Biologic recurrence documented by abnormal results in 2 assays of plasma PSA concentration in the same laboratory.
- Value of the plasma concentration of the last PSA assay during the 4 months preceding D0: 0.05 ng / mL ≤ PSA <1.6 ng / mL
Key exclusion criteria (8 listed)
- Another progressive cancerous condition, except for basal cell cancers.
- Acute inflammatory condition,
- Implementation of treatment (eg chemotherapy) or change of treatment (eg hormone therapy) since skeletal scintigraphy, abdominopelvic MRI or the last serum PSA test.
- Radiotherapy, chemotherapy or other anti-tumor treatment during the 6 weeks preceding PET,
- Agitation; impossibility to hold motionless for at least 1 hour, or known claustrophobia
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-HBED-CC-PSMA PET / CTPatient will receive a specific PET / CT with PSMA | Diagnostic test | 68Ga-HBED-CC-PSMA PET / CT |
Primary outcome
added value of 68Ga-HBED-CC-PSMA PET / CT in imaging examinations in terms of detection sensitivity of recurrence sites
Time frame: 6 months
To determine the added value of 68Ga-HBED-CC-PSMA PET / CT in imaging examinations in terms of detection sensitivity of prostate cancer recurrence sites, biologically suspected of elevated plasma concentrations of PSA, while all conventional imaging tests are negative or questionable: "occult recurrence".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Derived from this study: PubMed 31421657Rousseau C, Le Thiec M, Ferrer L, Rusu D, Rauscher A, Maucherat B, Frindel M, Baumgartner P, Fleury V, Denis A, Morel A, Varmenot N, Debeaupuis E, Campion L, Kraeber-Bodere F. Preliminary results of a 68 Ga-PSMA PET/CT prospective study in prostate cancer patients with occult recurrence: Diagnostic performance and impact on therapeutic decision-making. Prostate. 2019 Sep;79(13):1514-1522. doi: 10.1002/pros.23869. Epub 2019 Aug 17.
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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.
ROUSSEAU Caroline, MD principal investigator
Institut de Cancérologie de l'Ouest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-HBED-CC-PSMA PET / CT in people with Prostate Cancer Recurrent, run by Institut Cancerologie de l'Ouest 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 10 inclusion and 8 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: finished, as of the sponsor's last update on 21 May 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
added value of 68Ga-HBED-CC-PSMA PET / CT in imaging examinations in terms of detection sensitivity of recurrence sites (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03443609, which also lists 1 linked publication.
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 21 May 2021.