A Phase I Study to Evaluate the Safety and Dosimetry of Imaging With 68Ga-OncoACP3 in Prostate Cancer
ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorPhilogen S.p.A.
About this trial
The aim of this study is to assess the safety and dosimetry of imaging with \[68Ga\]Ga-OncoACP3 in patients with prostate cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
suspected metastasis who are candidates for initial definitive therapy
suspected recurrence based on elevated serum prostate-specific antigen (PSA) level (i.e., a progressive and confirmed serum PSA level > 0.2 ng/mL)
metastatic disease who might be candidates for treatment with 177Lu-labelled PSMA ligands. (Note: patients with a negative PSMA-PET/CT or discordant PSMA-PET and FDG-PET findings are eligible for this study, providing that they have a histologically confirmed diagnosis of prostate cancer)
Subjects able to father children must agree to practice effective contraception for three months starting from the study drug administration.
Disqualifiers
Chronically impaired renal function as expressed by creatinine clearance < 60 mL/min or serum creatinine > 1.5 x ULN. Note: it is sufficient to evaluate either creatinine clearance or serum creatinine
Presence of active hepatitis.
Presence of significant cardiac disorders (congestive heart failure, NYHA class III-IV, myocardial infarction within one year prior to study entry, uncontrolled hypertension, or arrhythmia).
Any concomitant condition which in the opinion of investigators makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
Trial design
Design model
Parallel
Treatments tested in this trial
[68Ga]Ga-OncoACP3
DrugSingle intravenous bolus injection.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Cohort AExperimental treatment 1 intervention
Group B: Cohort BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events (AEs) and Serious Adverse Events (SAEs)
Adverse events (AEs) and Serious Adverse Events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) v.6.0.
Time frame
Throughout study, until a maximum of 7 days after the administration of the study drug.2
Effective dose equivalent (mSv) and absorbed doses (mGy)
Effective dose equivalent (mSv) and absorbed doses (mGy) of normal organs following administration of a single dose of \[68Ga\]Ga-OncoACP3.
Time frame
Assessed on day 1Sponsors and contacts
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Source ClinicalTrials.gov