Clinical use of [18F]florastamine PET/CT in patients with PI-RADS≤3 report of multi-parametric MRI and suspected prostate cancer

2023-510421-14-00 Protocol IASON FC303 Therapeutic confirmatory (Phase III) Ended

End 3 Sep 2025 · Status Ended · 1 EU/EEA countries · 2 sites · Protocol IASON FC303

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ended
Participants planned 71
Countries 1
Sites 2

Prostate cancer

To analyse the sensitivity of florastamin (18F) PET/CT in localisation of csPCa in patients with elevated serum PSA levels and/or PSA density and with clinical suspicion of PCa and with report of PI-RADS v2.1.

Key facts

Sponsor
Curium Austria GmbH
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male
Therapeutic area
Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Trial duration
completed 3 Sep 2025
Decision date (initial)
2024-08-12
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2023-510421-14-00
EudraCT number
2020-005042-42

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Diagnosis, Efficacy

To analyse the sensitivity of florastamin (18F) PET/CT in localisation of csPCa in patients with elevated serum PSA levels and/or PSA density and with clinical suspicion of PCa and with report of PI-RADS v2.1.

Secondary objectives 9

  1. To assess the patient-based specificity and positive and negative predictive value of florastamin (18F) PET/CT for localisation of csPCa
  2. To assess the site-based sensitivity, specificity, positive and negative predictive value of florastamin (18F) PET/CT for localisation of csPCa
  3. To assess the net reclassification index (NRI) of florastamin (18F) for localisation of csPCa
  4. To assess the frequency of impact of florastamin (18F) PET/CT on diagnostic thinking.
  5. To assess the frequency of impact of florastamin (18F) PET/CT on patient management.
  6. To correlate the patient based diagnostic performance of florastamin (18F) PET/CT in detection of csPCa in patients with prostate health index (PHI) when available.
  7. To correlate quantitative uptake of florastamin (18F) with diagnostic performances in localization of csPCa.
  8. To correlate quantitative uptake of florastamin (18F) with histopathological results.
  9. To refine the interpretation criteria of florastamin (18F) PET/CT.

Conditions and MedDRA coding

Prostate cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

  1. Male gender
  2. Age ≥18 years
  3. PSA ≥10ng/mL and/or PSAD≥0.26 ng/mL2
  4. PI-RADS v2 ≤3 report of mpMRI performed less than 3 months prior inclusion
  5. Availability of mpMRI data for centralized reading
  6. Patient scheduled for biopsy or radical prostatectomy
  7. Signed informed consent

Exclusion criteria 7

  1. Absence of any of the inclusion criteria
  2. Androgen deprivation therapy or any targeted treatment for PCa prior florastamin (18F) PET/CT.
  3. Hypersensitivity to active substance or any of excipients of investigational medicinal product
  4. Life expectancy <6 months
  5. ECOG performance status >2
  6. Concomitant active malignancy and/or confirmed metastases
  7. Past history of confirmed prostate cancer.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Localisation of csPCa in patients with elevated serum PSA levels and/or PSA density and clinical suspicion of PCa. Percentage of true positive (TP) patients among TP divided by (TP + false negative (FN)).

Secondary endpoints 10

  1. Percentage of true negative (TN) patients among TN divided by (TN + false positive (FP)).
  2. Percentage of true positive (TP) sites among TP divided by (TP + false negative (FN)).
  3. NRI of florastamin (18F).
  4. Percentage of patients in whom the initially scheduled diagnostic thinking has been modified based on florastamin (18F) PET/CT results.
  5. Percentage of patients in whom the therapeutic management of PCa has been modified based on florastamin (18F) PET/CT results.
  6. Correlation of patient based diagnostic performance of florastamin (18F) PET/CT with PHI when available.
  7. Quantitative uptake of florastamin (18F) by csPCa
  8. Percentage adverse events observed during the first 24 hours florastamin (18F) administration.
  9. Correlation of quantitative uptake of florastamin (18F) with histopathological results.
  10. Establishment of interpretation criteria.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Prostavue

PRD10229827 · Product

Active substance
(9S13S-1-1-2-2-2-18FFLUOROETHOXYETHOXYETHYL-1H-123-TRIAZOL-4-YL-311-DIOXO-241012-TETRAAZAPENTADECANE-91315-TRICARBOXYLICACID
Other product name
Florastamin (18F)
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS INJECTION
Max daily dose
5 MBq/kg megabecquerel(s)/kilogram
Max total dose
5 MBq/kg megabecquerel(s)/kilogram
Max treatment duration
1 Day(s)
Authorisation status
Not Authorised
ATC code
V09IX — OTHER DIAGNOSTIC RADIOPHARMACEUTICALS FOR TUMOUR DETECTION
MA holder
CURIUM AUSTRIA GMBH
Paediatric formulation
No
Orphan designation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Curium Austria GmbH

Sponsor organisation
Curium Austria GmbH
Address
Grazer Strasse 18
City
Hausmannstaetten
Postcode
8071
Country
Austria

Scientific contact point

Organisation
Curium Austria GmbH
Contact name
Clinical development Lead

Public contact point

Organisation
Curium Austria GmbH
Contact name
Clinical development Lead

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ended 71 2
Rest of world — 0 —

Investigational sites

Austria

2 sites · Ended
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Abteilung für Nuklearmedizin und Endokrinologie, Feschnigstrasse 11, Klagenfurt,09.Bez.:Annabichl, Klagenfurt Am Woerthersee
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Nuclear medicine, Muellner Hauptstrasse 48, 5020, Salzburg

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 4.0
Recruitment arrangements (for publication) Blank_document 1
Subject information and informed consent form (for publication) L1_ SIS and ICF_Main ICF 5.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_ENG 4.0

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-07-10 Austria Acceptable
2024-08-09
 2024-08-12

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