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AzTrials

Prostate Cancer RecurrentPROPER-ABXNCT04239742

F18-PSMA-1007 PET for Early Biochemical Recurrence of Prostate Cancer

A study testing F18-fluciclovine PET/CT and F18-PSMA-1007 PET/CT in people with Prostate Cancer Recurrent, run by Radboud University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

18F-PSMA-1007 is a new radiopharmaceutical for the detection of prostate cancer with potential benefits over the registered 18F-Fluciclovine (Axumin). The main potential benefit is the higher detection rate of PSMA compared to Fluciclovin in the low PSA range. 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?
F18-fluciclovine PET/CT and F18-PSMA-1007 PET/CT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteNetherlands
Study dates
2 Jan 2020to Jan 2023
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

  • Males ≥ 18 years
  • Histologically proven adenocarcinoma of the prostate
  • Prior local treatment with curative intent
  • Biochemical recurrence with (rising) PSA-levels of 0.2-5.0 ug/L
  • Referred by urologist for PET/CT for localization of the recurrence
  • PSA level determined <8 weeks before study participation
  • Willing to sign informed consent

Who cannot join

  • Contra-indications for PET-CT: claustrophobia or inability to lay still for the duration of the exam.
  • Other cancer <2 years prior to biochemical recurrence of prostate cancer

Trial locations and contacts

1 site in 1 country.

Willemijn van Gemert, MD, PhD contact

0031243614510

willemijn.vangemert@radboudumc.nl

James Nagarajah, MD, PhD contact

0031243614510

James.nagarajah@radboudumc.nl

Netherlands1 site, 1 recruiting

  • Radboudumc

    Nijmegen

    Willemijn van Gemert, MD, PhD, 0243614510, willemijn.vangemert@radboudumc.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: F18-PSMA-1007 PET for Early Biochemical Recurrence of Prostate Cancer, Comparison With 18F-Fluciclovine

18F-PSMA-1007 is a new radiopharmaceutical for the detection of prostate cancer with potential benefits over the registered 18F-Fluciclovine (Axumin). The main potential benefit is the higher detection rate of PSMA compared to Fluciclovin in the low PSA range. It may therefore be more sensitive in detecting local disease in case of biochemical recurrens. The investigators aim to compare the detection efficacy of 18F-PSMA-1007 to 18F-Fluciclovin in prostate cancer patients with biochemical recurrence (PSA levels 0.2-5 ng/ml).

Read the detailed description

Rationale: 18F-PSMA-1007 is a new radiopharmaceutical for detection of prostate cancer with potential benefits over 18F-Fluciclovine, such as higher detection rates at low PSA levels and small lesions, lower bone marrow uptake and higher tumour-background ratio. Therefore, 18F-PSMA-1007 PET may be more sensitive in detecting local recurrence and metastases of prostate cancer. However, Fluciclovine is a registered tracer, whereas PSMA-1007 is not registered, and therefore there is pressure to use fluciclovine instead of PSMA-1007. Therefore more comparative data are urgently needed.

Objective: Main objective is to compare detection efficacy of 18F-PSMA-1007 PET-CT to 18F-Fluciclovine, in patients with early biochemical recurrence of prostate cancer.

Study design: Comparative phase II diagnostic study Study population: 50 males >18 years, with biochemical recurrence of prostate cancer and PSA-levels between 0.2-5.0 ng/mL. About 25 of the patients must have PSA-levels between 0.2-1.0 ng/mL. Contra-indications: claustrophobia, inability to lay still for the duration of the exam. Already established local recurrence in the prostate is not a contra-indication for study participation.

Intervention: 50 patients who already were referred by their treating physician for PET/CT will receive both an 18F-PSMA-1007 PET-CT (90 minutes post injection) and an 18F-Fluciclovine PET-CT (<15 minutes post injection). Injected dose of the 18F-PSMA-1007 will be 4 MBq/kg ±10%. The injected dose of 18F-Fluciclovine is 370 MBq ±10%.

Analysis: A clinical report is made of both the 18F-PSMA-1007 PET-CT scan and 18F-Fluciclovine PET-CT scan. For further analysis in the study all data will be anonymized, and will be blindly scored by two nuclear medicine physicians. The number of PET-positive lesions (judged to be prostate cancer, of course PET positive lesions referring to different processes like inflammation will not be taken intob account, this is oart of the PET-reading process) per area are separately scored for both tracers. Lesions will be scored on a 5-point scale ranging from most probably benign to most probably malignant. Follow-up data of the patients, to determine the eventual outcome, will be extracted from their medical file. An expert panel will eventually decide which lesions are considered to be metastases using all available follow-up data.

Being tested
F18-fluciclovine PET/CT, F18-PSMA-1007 PET/CT
Keywords
18F-PSMA-1007, 18F-Fluciclovine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • F18-fluciclovine PET/CTDiagnostic test

    Also called Axumin scan

    370 MBq ±10% 18F-Fluciclovin + low-dose CT scan, from skull base to pelvis.

  • F18-PSMA-1007 PET/CTDiagnostic test

    Also called PSMA scan

    4 MBq/kg ±10% F18-PSMA + low-dose CT scan, from skull base to pelvis

Study groups in NCT04239742
Study groupRoleWhat they receive
18F-PSMA PET/CT and 18F-Fluciclovin PET/CTExperimentalpatients undergo an 18F-PSMA PET/CT scan and an 18F-Fluciclovin PET/CT scan, within a time frame of two weeks.
Receives: Diagnostic Test: F18-fluciclovine PET/CT; Diagnostic Test: F18-PSMA-1007 PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Detection efficacy of the two PET-tracers on a per patient level

    Comparisson of number of patients with a positive scan

    Measured: Follow-up duration is 6 months.

  2. Detection efficacy of the two PET-tracers on a per lesion level

    Comparisson of number of positive lesions

    Measured: Follow-up duration is 6 months.

Secondary outcomes (7)

  1. Quantitative analysis

    tumour background ratio, SUV (of tumor and normal organs)

    Measured: 6 months

  2. Comparing specificity

    where the reference is consensus by the expert panel using all available information including 6 months follow up data (PSA-values; absolute and doublind time, pathology reports of suspected prostate cancer lesions, prostate-cancer targeted imaging by PET CT, MRI, CT or bone scan).

    Measured: 6 months

  3. Sensitivity per area, local recurrence

    local recurrence, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.

    Measured: 6 months

  4. Sensitivity per area, locoregional lymph nodes

    locoregional lymph nodes, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.

    Measured: 6 months

  5. Sensitivity per area, distant lymph nodes

    Distant lymph nodes, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.

    Measured: 6 months

  6. Sensitivity per area, bone metastases

    Bone metastases, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.

    Measured: 6 months

  7. Sensitivity per area, extraskeletal organ metastases, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.

    Extraskeletal organ metastases

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2020
  2. Study start2 Jan 2020
  3. Primary completionJan 2022 (estimated)
  4. Study completionJan 2023 (estimated)

Resources

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
every individual gets two diagnostic PET CT scans within 2 weeks apart.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04239742
Sponsor's protocol ID
NL65593.091.18
Acronym
PROPER-ABX
Status last verified
Jan 2020
First submitted
13 Jan 2020
Last updated
27 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Loeff CC, van Gemert W, Prive BM, van Oort IM, Hermsen R, Somford DM, Nagarajah J, Heijmen L, Janssen MJR. [18F]PSMA-1007 PET for biochemical recurrence of prostate cancer, a comparison with [18F]Fluciclovine. EJNMMI Rep. 2024 Nov 27;8(1):38. doi: 10.1186/s41824-024-00228-2.

    PubMed 39592501

Questions about this trial

What is this clinical trial studying?

A study testing F18-fluciclovine PET/CT and F18-PSMA-1007 PET/CT in people with Prostate Cancer Recurrent, run by Radboud University Medical Center at 1 site in Netherlands.

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 7 inclusion and 2 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 27 Jan 2020. 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 Netherlands. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Willemijn van Gemert, MD, PhD (0031243614510, willemijn.vangemert@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection efficacy of the two PET-tracers on a per patient level (time frame: Follow-up duration is 6 months.). The study lists 2 primary outcomes in all. 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 NCT04239742, 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 27 Jan 2020.

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