Safety and diagnostic performance of uPAR PET imaging in localised, untreated prostate cancer.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Curasight A/S

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

3 Jun 2024 → ongoing

Decision date (initial)

2024-04-10

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Safety, Pharmacokinetic

Part 1: To assess the robustness of SUVmax measurements obtained at a 64Cu DOTA-AE105 dose of 100 MBq, 150 MBq, and 200 MBq in patients with untreated, localised PCa.
Part 2: To determine the disciminative properties of uPAR PET (SUVmax) for the classification of ISUP grades 1 form 2 and ISUP grades 2 from 3 in patients with untreated, localised PCa.

Secondary objectives 9

1. Part 1: To evaluate the day-to-day variation (within patient reproducibility) of SUVmax at 100 MBq, 150 MBq, or 200 MBq 64Cu DOTA AE105.
2. Part 1: To determine the pharmacokinetics (PK) of 64Cu-DOTA-AE105.
3. Part 1: To determine inter-reader and intra-reader variability in SUV calculations.
4. Part 1: To determine the inter-reader and intra-reader variation in tumour visibility.
5. Part 1: To assess SUVmax and tumour visibility following a single intravenous injection of 64Cu DOTA AE105 using different acquisition durations.
6. Part 2: To determine the variation between the local unblinded read and the central blinded read.
7. Part 2: To determine agreement among a local, unblinded reader and a consensus from a blinded central read.
8. Part 2: To determine the inter reader and intra-reader variability.
9. Part 2: To determine the inter reader and intra-reader agreement in tumour visibility.

Conditions and MedDRA coding

Prostate Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Pathology-verified prostate adenocarcinoma
2. Pathology material available for central review
3. International Society of Urological Pathology (ISUP) grade 1 to 3
4. Localised prostate cancer. a. No clinical suspicion of prostate cancer outside the prostatic bed at the time of enrolment into the trial; and b. If N- and M- staging has been performed (at the initial staging or at any later time points), the results must be N0 and M0.
5. Prostate biopsy within 1 to 6 months prior to the first planned day of injection of 64Cu-DOTA-AE105 (patients with a biopsy within the last month are excluded to avoid possible inflammation artefacts on the PET scan) a. The biopsy can be part of the primary staging, a confir matory biopsy, or serial biopsy conducted as part of an AS or watchful waiting program. b. At least 1 core must be MRI-guided.

Exclusion criteria 4

1. Any prior treatment for prostate cancer (surgery, external beam radiation therapy, brachytherapy, hormone therapy, or chemotherapy
2. Chronic prostatitis (any signs or symptoms of chronic bacterial prostatitis or chronic pelvic prostatitis and pain syndrome, or known diagnosis of asymptomatic inflammatory prostatitis).
3. Acute infections within the prostatic bed or lower urinary tract infections.
4. Participants have inadequate bone marrow, kidney, liver, heart, or lung function

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Part 1: SUVmax at 30, 60, and 120-min. post-injection
2. Part 2: SUVmax in PET acquisitions at 60 min p.i. of 200 MBq.

Secondary endpoints 9

1. Part 1: SUVmax in PET acquisitions at 60 min post-injection on days 1 and 8.
2. Part 1: Evaluate PK parameters Cmax, Tmax, AUC, Vd, clearance, T1/2 from periodic radioactive counts from whole blood plus the elimination of 64Cu DOTA AE105 into a pooled urine sample to determine activity per mL which will be extrapolated to the mass dose (pg/mL) of IMP.
3. Part 1: SUVmax in PET acquisitions at 30, 60 and 120 min p.i.
4. Part 1: Tumour visibility (numerical rating scale [NRS], 0–2 rating) in PET acquisitions at 30, 60 and 120 min p.i.
5. Part 1: a) SUVmax centred around 60 min p.i. with reconstructions of 3-, 5-, 10-, 20-, 30-, and 40-min frame durations in the 200 MBq cohort. b) Tumour visibility (NRS 0–2 rating) centred around 60 min p.i. with reconstructions of 3-, 5-, 10-, 20-, 30, and 40-min frame durations in the 200 MBq cohort.
6. Part 2: SUVmax in PET acquisitions at 60 min p.i.
7. Part 2: Tumour visibility (NRS 0–2 rating) in PET acquisitions at 60 min p.i.
8. Part 2: SUVmax in PET acquisitions at 60 min p.i.
9. Part 2: Tumour visibility (NRS 0–2 rating) in PET acquisitions at 60 min p.i.

Investigational products

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

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Curasight A/S

Sponsor organisation

Curasight A/S

Address

Ole Maaloees Vej 3

City

Copenhagen N

Postcode

2200

Country

Denmark

Scientific contact point

Organisation

Curasight A/S

Contact name

[email protected]

Public contact point

Organisation

Curasight A/S

Contact name

[email protected]

Third parties 3

Locations

3 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 28 files

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

Application history

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