None listed
Conditions
Brief summary
This study aims to mitigate nephrotoxicity and enhance the therapeutic benefits of Lutetium-177 PSMA-I&T treatment by introducing an amino acid infusion as a renal protective measure. Who is it for? You may be eligible for this study if you are an adult male with confirmed prostate cancer and considered for ongoing treatment with 177Lu–PSMA-617. Study details: Participants will receive an amino acid infusion before their 4th, 5th, or 6th treatment cycle. Renal dosimetry will be assessed using 3D SPECT/CT imaging after this cycle and compared to the renal dosimetry of the same patients at the preceding cycle without amino acid infusion. It is hoped that findings from this study will help establish a protocol to reduce renal toxicity in patients undergoing radiotheranostics, thereby improving patient outcomes and safety profiles.
Interventions
a) 1000 mL of SYNTHAMIN 17 (Amino acids 10%) without electrolytes solution will be administered intravenously at a rate of 250 mL/h over a four-hour period.
b) The infusion will commence 30–60 minutes prior to Lutetium-177 PSMA-I&T therapy.
c) The infusion will be administered by a registered nurse.
d) Adherence will be monitored via patient observation, as well as recording the administration details in the Investigational Drug
e) There will be a 6-week interval between treatment
a) 1000 mL of SYNTHAMIN 17 (Amino acids 10%) without electrolytes solution will be administered intravenously at a rate of 250 mL/h over a four-hour period. b) The infusion will commence 30–60 minutes prior to Lutetium-177 PSMA-I&T therapy. c) The infusion will be administered by a registered nurse. d) Adherence will be monitored via patient observation, as well as recording the administration details in the Investigational Drug e) There will be a 6-week interval between treatment cycles.
Sponsors
Fiona Stanley Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male patients aged >18 yrs 2. History of histologically confirmed prostate cancer 3. Metastatic patients who are considered for ongoing treatment with 177Lu–PSMA-617 4. Ability to understand and the willingness to sign a written informed consent
Exclusion criteria
1. Life expectancy less than 6 months 2. Unable to give informed consent 3. Unable to comply with required scanning schedule. 4. Other malignant tumors that are likely to express PSMA, such as salivary gland, renal or hepatocellular carcinoma
Outcome results
None listed