Prostate CancerNCT05079828
Head-to-head Comparison of 68Ga-PSMA-11 and 18F-PSMA-1007
A study testing 18F-PSMA-1007 and 68Ga-PSMA-11 in people with Prostate Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The aim of this study is to provide robust data on the head-to-head comparison of the two ligands of the prostate specific membrane antigen (PSMA) available in Switzerland for positron emission tomography (PET)-imaging, i.e. 68Ga-PSMA-11 und 18F-PSMA-1007. 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?
- 18F-PSMA-1007 and 68Ga-PSMA-11
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Jul 2022to 30 Oct 2024
- 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
- Patients with known biochemical recurrence of a histologically confirmed prostate cancer post radical prostatectomy, defined as two consecutive prostate specific antigen (PSA) values > 0.2 ng/ml:
- Post prostatectomy: Patients > 18 y/o
- PSA measured within ± 4 weeks of the first PSMA-PET/CT
- Patients providing written informed consent
- No change in PC treatment in the period between the first and second scans
Who cannot join
- Patients receiving androgen deprivation therapy (ADT) within 6 months prior to the PSMA-PET/CT
- Patients with contraindication to diuresis with 20mg Furosemide
- Patients with renal dialysis or relevant renal impairment (eGFR < 35 ml/min)
- Inability to provide written informed consent
- Inability to schedule and attend two consecutive PET examinations
- Patients undergoing active treatment for a second non-prostatic malignancy at the time of the first scan.
- Known sensitivity or allergy to PSMA-ligands or one of the components of the radiotracer solutions used.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Head-to-head Comparison of 68Ga-PSMA-11 and 18F-PSMA-1007 for the Detection of Recurrent Prostate Cancer in PSMA-ligand PET/CT
The aim of this study is to provide robust data on the head-to-head comparison of the two ligands of the prostate specific membrane antigen (PSMA) available in Switzerland for positron emission tomography (PET)-imaging, i.e. 68Ga-PSMA-11 und 18F-PSMA-1007.
Read the detailed description
Prostate Cancer (PC) is the most common malignancy in men and the second leading cause of cancer-related death in men. Despite initial therapy at early stage disease, biochemical recurrence remains a commonly encountered entity and presents a challenge for conventional imaging modalities given their limited abilities to detect disease at early stages of recurrence.
PET/CT with ligands of the prostate specific membrane antigen has been shown to have a significant impact on treatment and is now the sine qua non for staging of recurrent PC. For example, accurate identification of PC lesions allows for more accurate radiotherapy planning, allowing for an individualised treatment strategy. There is therefore a substantial clinical requirement for the accurate identification and stratification of individuals in whom prostate cancer is diagnosed and at earlier stages of recurrent disease when the chance of a curative treatment is at its highest.
It is in this context that PSMA has become the focus of much attention owing to its high levels of expression on PC cells and has rapidly established itself as the investigation of choice in recurrent PC. Furthermore, PSMA-directed radioligand therapy is a rapidly evolving treatment modality for metastatic disease, creating an additional therapeutic role for PSMA-ligand molecular imaging, for which the term "theragnostics" has been coined. The challenge for nuclear medicine is therefore to develop tracers and examination protocols that provide optimal detection and characterisation of disease, thus improving upon this promising technique.
There are currently no published prospective head-to-head studies comparing these two tracers in recurrent PC. Because of this lack of data, there are no clear recommendations about which tracer to use and in which situation.
This study aims to fill this gap and provide comprehensive data with the potential to improve the diagnosis of PC. By providing robust data comparing the two tracers, such data will also provide guidance to clinicians faced with the scenario of an initially negative 68Ga-PSMA-11 PET as to the diagnostic utility of an additional 18F-PSMA-1007 PET, or vice-versa, and in which scenarios repeated scanning may be justified.
Finally, the application of the radiotracer into the same patient allows for a comparison of tracer kinetics. Although radiotracer kinetics are well known from the original pioneering dosimetric publications, they have never been compared in a head to head fashion and not in biochemical recurrence. Obtaining dynamic scans over the first hour post injection will allow intra-individual dosimetry and a head-to-head comparison of parametric imaging parameters, allowing a direct comparison of the radiotracer's affinity using standard parametric imaging techniques.
- Conditions
- Prostate Cancer
- Being tested
- 18F-PSMA-1007, 68Ga-PSMA-11
- Keywords
- PSMA, 68Ga-PSMA-11, 18F-PSMA-1007, PET/CT, recurrent prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-PSMA-1007Diagnostic test
PET/CT scan using 18F-PSMA-1007
68Ga-PSMA-11Diagnostic test
PET/CT scan using 68Ga-PSMA-11
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Patients receive first a PET/CT with 68Ga-PSMA-11 and a second PET/CT with 18F-PSMA-1007 Receives: Diagnostic Test: 18F-PSMA-1007; Diagnostic Test: 68Ga-PSMA-11 |
| Arm 2 | Active comparator | Patients receive first a PET/CT with 18F-PSMA-1007 and a second with 68Ga-PSMA-11 Receives: Diagnostic Test: 18F-PSMA-1007; Diagnostic Test: 68Ga-PSMA-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-level detection rate
The primary endpoint is the proportion of patients with a pathological PSMA-positive finding (= patient-based sensitivity) at one time-point (2h) with the existing standard-of-care (68Ga-PSMA-11) compared to the new tracer (18F-PSMA-1007).
Measured: 3-6 months following final scan
Secondary outcomes (7)
Comparison of tracer kinetics
Intra-individual comparison of the parametric imaging parameter KD (measure of tracer affinity) for the two radiotracers.
Measured: For the first n=10 individuals, expected to be after 3 months
Per region-based detection rate
- The number of pathological, benign and uncertain lesions for each tracer in five regions (prostate bed, pelvic lymph nodes, extra-pelvic lymph nodes, bone, or other organs) classified by six blinded readers (three for each tracer) using previously published interpretation guidelines (PSMA-Rads 1.0)
Measured: Confirmed by 12 months' follow up from date of scan to a composite standard
Interreader reliability
Readers shall independently classify all PSMA-avid lesions according to previously published diagnostic criteria. The frequency of benign, equivocal and pathological lesions will be noted. Lesions will additionally be classified by region (prostate bed (T), pelvic lymph nodes (N), extrapelvic lymph nodes (M1a), bone (M1b) or other organs (M1c)). The interreader reliability for these classifications will be compared between all readers.
Measured: Within 3-6 months of last scan
Region based PPV
- The positive predictive value (PPV) stratified by region (local recurrence, lymph node, solid organ, bone) i.e. the percentage of pathological lesions that are confirmed pathological at the twelve months follow-up (based on the subset of patients and lesions with follow-up data at twelve months).
Measured: 12 months from the last scan
Lesion semiquantitative radiotracer uptake
- semiquantitative radiotracer uptake will be assessed by standardised uptake values (SUV) as well as tumour to background contrast in a lesion based analysis. The tumour to background ratio (TBR) is defined as lesion SUV ÷ SUV of reference background region, where the background uptake is defined by convention as the left gluteal musculature
Measured: Within 6 months of scan date
Number of patients with adverse events and their severity
- Number and severity of adverse events per tracer (up to 48 hours follow up).
Measured: 48 hours
Lesion based PPV
In a second round of tumour classification, two readers (in consensus) will classify each lesion as pathological, benign or uncertain in a lesion-specific approach and perform a lesion based follow-up to assess PPV on the lesion level.
Measured: 12 months from the last scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start7 Jul 2022
- Primary completion1 May 2024
- Study completion30 Oct 2024
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 CancerStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will be randomised to receive a PET/CT with either 18F-PSMA-1007 and a second exam with 68Ga-PSMA-11 or vice-versa, in the reverse order.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Axel Rominger, MD, Study chair, Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079828
- Sponsor's protocol ID
- 2020-02903
- Status last verified
- Dec 2024
- First submitted
- 13 Jul 2021
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data available upon reasonable request
Publications
Alberts I, Butikofer L, Rominger A, Afshar-Oromieh A. A randomised, prospective and head-to-head comparison of [68Ga]Ga-PSMA-11 and [18F]PSMA-1007 for the detection of recurrent prostate cancer in PSMA-ligand PET/CT-Protocol design and rationale. PLoS One. 2022 Jul 19;17(7):e0270269. doi: 10.1371/journal.pone.0270269. eCollection 2022.
PubMed 35853017
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head-to-head Comparison of 68Ga-PSMA-11 and 18F-PSMA-1007 for the Detection of Recurrent Prostate Cancer in PSMA-ligand PET/CT
- ClinicalTrials.gov ID
- NCT05079828
- Acronym / sponsor ID
- 2020-02903
- Conditions
- Prostate Cancer
- Keywords
- PSMA, 68Ga-PSMA-11, 18F-PSMA-1007, PET/CT, recurrent prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 15 Oct 2021 (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.
The aim of this study is to provide robust data on the head-to-head comparison of the two ligands of the prostate specific membrane antigen (PSMA) available in Switzerland for positron emission tomography (PET)-imaging, i.e. 68Ga-PSMA-11 und 18F-PSMA-1007.
Detailed description
Prostate Cancer (PC) is the most common malignancy in men and the second leading cause of cancer-related death in men. Despite initial therapy at early stage disease, biochemical recurrence remains a commonly encountered entity and presents a challenge for conventional imaging modalities given their limited abilities to detect disease at early stages of recurrence.
PET/CT with ligands of the prostate specific membrane antigen has been shown to have a significant impact on treatment and is now the sine qua non for staging of recurrent PC. For example, accurate identification of PC lesions allows for more accurate radiotherapy planning, allowing for an individualised treatment strategy. There is therefore a substantial clinical requirement for the accurate identification and stratification of individuals in whom prostate cancer is diagnosed and at earlier stages of recurrent disease when the chance of a curative treatment is at its highest.
It is in this context that PSMA has become the focus of much attention owing to its high levels of expression on PC cells and has rapidly established itself as the investigation of choice in recurrent PC. Furthermore, PSMA-directed radioligand therapy is a rapidly evolving treatment modality for metastatic disease, creating an additional therapeutic role for PSMA-ligand molecular imaging, for which the term "theragnostics" has been coined. The challenge for nuclear medicine is therefore to develop tracers and examination protocols that provide optimal detection and characterisation of disease, thus improving upon this promising technique.
There are currently no published prospective head-to-head studies comparing these two tracers in recurrent PC. Because of this lack of data, there are no clear recommendations about which tracer to use and in which situation.
This study aims to fill this gap and provide comprehensive data with the potential to improve the diagnosis of PC. By providing robust data comparing the two tracers, such data will also provide guidance to clinicians faced with the scenario of an initially negative 68Ga-PSMA-11 PET as to the diagnostic utility of an additional 18F-PSMA-1007 PET, or vice-versa, and in which scenarios repeated scanning may be justified.
Finally, the application of the radiotracer into the same patient allows for a comparison of tracer kinetics. Although radiotracer kinetics are well known from the original pioneering dosimetric publications, they have never been compared in a head to head fashion and not in biochemical recurrence. Obtaining dynamic scans over the first hour post injection will allow intra-individual dosimetry and a head-to-head comparison of parametric imaging parameters, allowing a direct comparison of the radiotracer's affinity using standard parametric imaging techniques.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomised to receive a PET/CT with either 18F-PSMA-1007 and a second exam with 68Ga-PSMA-11 or vice-versa, in the reverse order.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Diagnostic Test: 18F-PSMA-1007, Diagnostic Test: 68Ga-PSMA-11Patients receive first a PET/CT with 68Ga-PSMA-11 and a second PET/CT with 18F-PSMA-1007 |
| Arm 2 | Active comparator | Diagnostic Test: 18F-PSMA-1007, Diagnostic Test: 68Ga-PSMA-11Patients receive first a PET/CT with 18F-PSMA-1007 and a second with 68Ga-PSMA-11 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with known biochemical recurrence of a histologically confirmed prostate cancer post radical prostatectomy, defined as two consecutive prostate specific antigen (PSA) values > 0.2 ng/ml:
- Post prostatectomy: Patients > 18 y/o
- PSA measured within ± 4 weeks of the first PSMA-PET/CT
- Patients providing written informed consent
- No change in PC treatment in the period between the first and second scans
Key exclusion criteria (7 listed)
- Patients receiving androgen deprivation therapy (ADT) within 6 months prior to the PSMA-PET/CT
- Patients with contraindication to diuresis with 20mg Furosemide
- Patients with renal dialysis or relevant renal impairment (eGFR < 35 ml/min)
- Inability to provide written informed consent
- Inability to schedule and attend two consecutive PET examinations
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 |
|---|---|---|
| 18F-PSMA-1007PET/CT scan using 18F-PSMA-1007 | Diagnostic test | Arm 1, Arm 2 |
| 68Ga-PSMA-11PET/CT scan using 68Ga-PSMA-11 | Diagnostic test | Arm 1, Arm 2 |
Primary outcome
Patient-level detection rate
Time frame: 3-6 months following final scan
The primary endpoint is the proportion of patients with a pathological PSMA-positive finding (= patient-based sensitivity) at one time-point (2h) with the existing standard-of-care (68Ga-PSMA-11) compared to the new tracer (18F-PSMA-1007).
7 secondary outcomes
Comparison of tracer kinetics
Time frame: For the first n=10 individuals, expected to be after 3 months
Per region-based detection rate
Time frame: Confirmed by 12 months' follow up from date of scan to a composite standard
Interreader reliability
Time frame: Within 3-6 months of last scan
Region based PPV
Time frame: 12 months from the last scan
Lesion semiquantitative radiotracer uptake
Time frame: Within 6 months of scan date
Number of patients with adverse events and their severity
Time frame: 48 hours
Lesion based PPV
Time frame: 12 months from the last scan
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 10 Dec 2024.
- Derived from this study: PubMed 35853017Alberts I, Butikofer L, Rominger A, Afshar-Oromieh A. A randomised, prospective and head-to-head comparison of [68Ga]Ga-PSMA-11 and [18F]PSMA-1007 for the detection of recurrent prostate cancer in PSMA-ligand PET/CT-Protocol design and rationale. PLoS One. 2022 Jul 19;17(7):e0270269. doi: 10.1371/journal.pone.0270269. eCollection 2022.
- Individual participant dataSharing planned: No. Data available upon reasonable request
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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.
Axel Rominger, MD study chair
Inselspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-PSMA-1007 and 68Ga-PSMA-11 in people with Prostate Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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: finished, as of the sponsor's last update on 10 Dec 2024. 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 Switzerland. 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?
Patient-level detection rate (time frame: 3-6 months following final scan). 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 NCT05079828, 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 10 Dec 2024.