64CU-DOTA-AE105 for Prostate cancer

Inclusion criteria

• {"criterion_text":"- Pathology-verified prostate adenocarcinoma"}
• {"criterion_text":"- Pathology material available for central review"}
• {"criterion_text":"- International Society of Urological Pathology (ISUP) grade 1 to 3"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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.\tThe biopsy can be part of the primary staging, a confirmatory biopsy, or serial biopsy conducted as part of an AS or watchful waiting program. b.\tAt least 1 core must be MRI-guided."}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Part 1: SUVmax at 30, 60, and 120-min. post-injection","definition_or_measurement_approach":"SUVmax measured from PET acquisitions at 30, 60 and 120 minutes post-injection following administration of 64Cu-DOTA-AE105."}
• {"endpoint_text":"- Part 2: SUVmax in PET acquisitions at 60 min p.i. of 200 MBq.","definition_or_measurement_approach":"SUVmax measured in PET acquisitions at 60 minutes post-injection for the 200 MBq cohort."}

Secondary endpoints

• {"endpoint_text":"- Part 1: SUVmax in PET acquisitions at 60 min post-injection on days 1 and 8.","definition_or_measurement_approach":"SUVmax measured in PET acquisitions at 60 min post-injection on specified days (day 1 and day 8) to assess day-to-day variation."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Pharmacokinetic parameters (Cmax, Tmax, AUC, Vd, clearance, T1/2) determined from periodic radioactive counts in whole blood and pooled urine samples; activity per mL extrapolated to mass dose (pg/mL)."}
• {"endpoint_text":"- Part 1: SUVmax in PET acquisitions at 30, 60 and 120 min p.i.","definition_or_measurement_approach":"SUVmax measured in PET acquisitions at the listed post-injection time points."}
• {"endpoint_text":"- Part 1: Tumour visibility (numerical rating scale [NRS], 0–2 rating) in PET acquisitions at 30, 60 and 120 min p.i.","definition_or_measurement_approach":"Tumour visibility assessed using a numerical rating scale (NRS) 0–2 on PET acquisitions at 30, 60 and 120 minutes post-injection."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Analyses of SUVmax and tumour visibility centered at 60 min post-injection with varying reconstruction frame durations (3–40 min) in the 200 MBq cohort."}
• {"endpoint_text":"- Part 2: SUVmax in PET acquisitions at 60 min p.i.","definition_or_measurement_approach":"SUVmax measured at 60 minutes post-injection in Part 2 PET acquisitions."}
• {"endpoint_text":"- Part 2: Tumour visibility (NRS 0–2 rating) in PET acquisitions at 60 min p.i.","definition_or_measurement_approach":"Tumour visibility assessed using NRS 0–2 at 60 minutes post-injection in Part 2 PET acquisitions."}
• {"endpoint_text":"- Part 2: SUVmax in PET acquisitions at 60 min p.i.","definition_or_measurement_approach":"Duplicate listing: SUVmax measured at 60 minutes post-injection in Part 2 PET acquisitions."}
• {"endpoint_text":"- Part 2: Tumour visibility (NRS 0–2 rating) in PET acquisitions at 60 min p.i.","definition_or_measurement_approach":"Duplicate listing: tumour visibility assessed using NRS 0–2 at 60 minutes post-injection in Part 2 PET acquisitions."}

Denmark

Earliest CTIS Part Ii Submission Date

08-03-2024

Latest Decision Or Authorization Date

13-11-2025

Processing Time Days

615

Number Of Sites

3

Number Of Participants

70

Sweden

Earliest CTIS Part Ii Submission Date

08-03-2024

Latest Decision Or Authorization Date

17-11-2025

Processing Time Days

619

Number Of Sites

2

Number Of Participants

13

Germany

Earliest CTIS Part Ii Submission Date

20-02-2024

Latest Decision Or Authorization Date

17-11-2025

Processing Time Days

636

Number Of Sites

4

Number Of Participants

85

Primary sponsor

Full Name

Curasight A/S

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark

Contract research organisations

Name

Discovery Life Sciences Biomarker Services GmbH

Responsibilities

code:4

Name

Primevigilance Limited

Responsibilities

code:8

Name

ABX CRO advanced pharmaceutical services Forschungsgesellschaft mbH

Responsibilities

codes:1,10,11,12,2,5,6,7

Third parties

• {"country":"Germany","full_name":"Discovery Life Sciences Biomarker Services GmbH","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Primevigilance Limited","duties_or_roles":"code:8","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"ABX CRO advanced pharmaceutical services Forschungsgesellschaft mbH","duties_or_roles":"codes:1,10,11,12,2,5,6,7","organisation_type":"Pharmaceutical company"}