ACTRN12624000935538Not yet recruitingPhase 1
A Single-Arm Comparative Imaging study to evaluate the uptake of 68Ga-NTA-476 on PET/CT Compared to Standard of Care 18F-DCFPyL PET/CT in Men with Prostate Cancer
Melbourne Theranostic Innovation Centre0 sites10 target enrollmentStarted: August 1, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Diagnosis
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- Male
Inclusion Criteria
- •1. Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.
- •2. Adult participants greater than or equal to 18 years of age.
- •3. Participants with a documented history of histologically confirmed diagnosis of prostate cancer.
- •o Participants must have PSA > 0.1 ng/mL.
- •o Participants on chemotherapy may be approved on a case-by-case basis at the principal investigator's discretion if the last dose of chemotherapy is administered at least 3 weeks prior to receipt of 68Ga-NTA-476, and subsequent dose of chemotherapy are to resume following completion of End of Treatment Visit (EOTV), if it is determined not to put the patient at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome.
- •o Participants on other anti-cancer therapy, such as novel anti-androgen therapy, may be allowed on a case-by-case basis at the principal investigator's discretion, with an agreement of a washout period prior to 68Ga-NTA-476 dosing, if it is determined not to put the patient at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome.
- •4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
- •5. Participants must have a life expectancy of >3 months in the opinion of the Investigator.
- •6. Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 14 days after the last injection of 68Ga-NTA-476. Participants must agree to not donate sperm during the study and for 14 days after the injection of 68Ga-NTA-476. Acceptable methods of contraception include a condom in conjunction with hormonal contraception, a vaginal ring or intrauterine device (IUD), or documented evidence of surgical sterilisation. Confirmed absence of sperm in the ejaculate is also acceptable.
Exclusion Criteria
- •7. Have any medical condition that would, in the Investigator’s judgment, prevent the participant’s full participation in the clinical study due to safety concerns or compliance with clinical study procedures, including but not limited to participants with severe claustrophobia.
- •8. Residual toxicity > Grade 1 from prior/current anti-cancer therapy (except alopecia). Participants with > Grade 1 toxicity from prior anti-cancer therapy may be approved on a case-by-case basis at the principal investigator's discretion, if it is determined not to put the patient at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome.
- •9. History of uncontrolled allergic reactions and/or known or expected hypersensitivity to peptide therapeutics, including 68Ga-NTA-476 or any of its excipients.
- •10. Inadequate organ functions as reflected in laboratory parameters:
- •o Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min or serum creatinine >1.5 x upper limit of normal (ULN)
- •o Platelet count of < 75 x 109/L
- •o Absolute neutrophil count (ANC) < 1.0 x 109/L
- •o Haemoglobin < 9 g/dL
- •o Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x ULN, or > 5 x ULN for patients with known liver metastases
- •o Total bilirubin > 1.5 x ULN, except for patients with documented Gilbert’s syndrome who are eligible if total bilirubin is less than or equal to 3 x ULN
- •11. For participants not taking warfarin or other anticoagulants: international normalised ratio (INR) less than or equal to 1.5 or prothrombin time (PT) less than or equal to 1.5 x ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) less than or equal to 1.5 x ULN. Participants taking warfarin must be on a stable dose that results in a stable INR <3.5. Among participants receiving other anticoagulant therapy, PT or aPTT must be within the intended therapeutic range of the anticoagulant.
- •12. Major surgery within 28 days prior to the dose of 68Ga-NTA-476. Exceptions may be approved on a case-by-case basis at the principal investigator's discretion, if it is determined not to put the participant at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome.
- •13. Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy.
Investigators
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