None listed
Conditions
Brief summary
This study aims to assess whether a single dose of 177 Lutetium-PSMA-targeted therapy is safe and effective as a treatment for men who have developed biochemical failure after having a radical prostatectomy. Who is it for? You may be eligible for this study if you are a male aged 18 years or older who has recently undergone a radical prostatectomy (surgery to remove the prostate) due to a diagnosis of high or very high risk prostate cancer. Participants will undergo blood tests and MR imaging to determine whether they meet the additional criteria of biochemical failure. Study details All participants who choose to enrol in this study will receive a single dose of 177 Lutetium-PSMA-targeted therapy that will be administered intravenously (through a vein). Please note that any participants who are eligible for this study will need to pay out-of-pocket for the study treatment (177-Lu-PSMA-I&T) as well as the post-operative mpMRI (multiparametric Magnetic Resonance Imaging of the prostate). It is anticipated that the single dose will be administered over a 10-minute period followed by a saline (neutral fluid) flush. Participants will then be asked to provide blood samples at 3 months post-dose, and then every 4 months for up to 3 years post-dose. Participants will also be asked to complete a questionnaire about their health at 30 days, and then every 3-6 months for up to 3 years post-dose. Additional imaging scans will also be collected at 3 months post-dose, with the potential for further imaging to be determined by the treating clinician. It is hoped this research will determine whether a single dose of 177 Lutetium-PSMA-targeted therapy is safe and whether it has a positive impact on resistant prostate cancer. If this study does show that the drug is safe and effective, a larger study to examine potential benefits in more patients may proceed.
Interventions
Investigational drug: 177Lutetium-PSMA-I&T
Mechanism: Radioligand targeted therapy
Class: Radiopharmaceutical (theranostic)
Dose: 7.5GBq of 177Lu-PSMA-I&T (+/- 5%)
Dose volume: 10ml
Number of doses and duration: Single cycle (ie. 1x dose for the duration of the study)
Mode of delivery: Intravenous Infusion Duration
The timing of drug infusion relative to post-radical prostatectomy is variable but within 4 weeks of identifying PSA biochemical failure. (The first PSA testing is normally cond
Investigational drug: 177Lutetium-PSMA-I&T Mechanism: Radioligand targeted therapy Class: Radiopharmaceutical (theranostic) Dose: 7.5GBq of 177Lu-PSMA-I&T (+/- 5%) Dose volume: 10ml Number of doses and duration: Single cycle (ie. 1x dose for the duration of the study) Mode of delivery: Intravenous Infusion Duration The timing of drug infusion relative to post-radical prostatectomy is variable but within 4 weeks of identifying PSA biochemical failure. (The first PSA testing is normally conducted at their 6-week follow-up) Monitoring for drug adherence is not applicable (single dose for the duration of the study) Record of treatment administration and subsequent biochemistry will be recorded on the hospital's electronic medical record.
Sponsors
Dr Anthony-Joe Nassour
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Men who have undergone radical prostatectomy for National Comprehensive Cancer Network high or very high-risk prostate cancer. • Negative surgical margins on radical prostatectomy histopathology. • PSA initially undetectable following radical prostatectomy. • PSA biochemical failure – defined as greater than or equal to 0.20ng/mL • PSMA expressing prostate cancer on pre-operative 18F-DCFPyL PSMA PET/CT • 18F-DCFPyL PSMA PET/CT demonstrating no evidence of uptake to suggest detectable residual or metastatic disease • No local recurrence on post-operative mpMRI • No artifact disrupting interpretation of initial prostate cancer imaging • Significant PSMA expressing tumour on initial staging • Ability to give written informed consent, participate in and comply with study
Exclusion criteria
• Previous diagnosis of prostate cancer • Positive surgical margin on radical prostatectomy specimen pathology • Non-PSMA expressing prostate cancer (e.g. ductal or neuroendocrine) • Artifact disrupting interpretation of initial prostate cancer imaging (e.g. THR) • Presence of suspected metastatic disease on pre-operative and post-operative 18F-DCFPyL PSMA PET/CT scan or mpMRI • Undetectable serum testosterone • Contraindication to Gadolinium • Contraindication to 177Lu-PSMA therapy
Outcome results
None listed