None listed
Conditions
Brief summary
The aim of this study is to test the safety and effectiveness of prostate specific membrane antigen (PSMA) labelled with a radioactive substance called Lutetium-177 (177Lu) in progressive prostate cancer patients. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have a progressive PSMA expressing castration-resistant prostate cancer. Study details Participants will receive up to four 42-day cycles, with each cycle requiring a single intravenous injection of a radioactive substance called therapeutic 177 Lu-PSMA. The exact number of treatment cycles administered and dose given will be determined by the treating doctor. Participants will then be followed for one year after completion of study to assess safety and effectiveness of the intervention. Study rationale Using PSMA labelled molecules enables targeted delivery of high doses radiation to sites of prostate cancer. This treatment is called radionuclide therapy and it aims to minimise radiation of most normal tissue sites. Study Declarations This is a new type of treatment and long-term response and toxicity data are not yet available. The drugs used in this study are not approved by the Therapeutic Goods Administration (TGA) and considered an experimental treatment. This research has been initiated by the study doctor, A/Prof Louise Emmett, and is sponsored by St Vincent’s Hospital Sydney with funding provided by the St Vincent’s Prostate Cancer Centre. This will allow you to have the LuPSMA treatment free of charge for your conduct of the research.
Interventions
The study is designed as a prospective, open label, single arm non-randomised pilot study in men with prostate specific membrane antigen (PSMA) expressing castration-resistant progressive prostate cancer. Progression has to be within the preceding 6 months based on radiology and or symptomatic progression.
Participants will be screened to determine the suitability of participating in the study. During the screening visit(s) they will asked to sign consent, provide medical history, height, wei
The study is designed as a prospective, open label, single arm non-randomised pilot study in men with prostate specific membrane antigen (PSMA) expressing castration-resistant progressive prostate cancer. Progression has to be within the preceding 6 months based on radiology and or symptomatic progression. Participants will be screened to determine the suitability of participating in the study. During the screening visit(s) they will asked to sign consent, provide medical history, height, weight, physical assessment, undergo a 68Ga-PSMA PET/CT scan, FDG PET/CT scan, Isotope bone scan, contrast-enhanced CT (chest/ abdomen/ pelvis) scan, blood tests and complete questionnaires. If the participant is suitable to the study they will receive a single IV injection of 177 Lu-PSMA on day 0. The dose given is calculated by the doctor based on the participant's weight and volume of disease. Dose will vary between individuals with a dosage regimen of IV 4-8 GBq of 177Lu-PSMA activity, 50 micrograms PSMA per GBq. Participants will be monitored during and post injection by clinical trial team members. Blood samples will be taken after infusion and approximately 4 hours post administration a 177Lu-PSMA SPECT/CT will occur. Follow up post therapy imagining will occur at approximately 24 and 72 hours post injection with a 177Lu-PSMA SPECT/CT. Participants will be followed up on day 14 and 28 to assess the routine blood results and complete questionnaires. A full cycle comprises of a 42 day cycle and participants can receive up to four cycles of therapeutic 177Lu-PSMA. Participants will be routinely followed up with treating doctor before each cycle to assess benefit of treatment and adherence to study. For Cycles 2-4, participants follow the same schedule of events with the exemption that one a single time-point 177Lu-PSMA SPECT/CT will performed 1 day after administration of 177 Lu-PSMA .
Sponsors
St Vincent's Hospital
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
1. Age 18 years and older 2. Pathologically confirmed prostate adenocarcinoma 3. Castration-resistant metastatic disease, 4. Prior treatment with Abiraterone, Enzalutamide or both (unless contraindicated, medically unsuitable or patient refuses) 5. Prior Taxane-based chemotherapy (unless contraindicated, medically unsuitable or patient refuses) 6. Documented prostate cancer progression within last 12 months as defined by PSA progression (minimum of three rising PSA levels with an interval of greater than 1 week between each determination OR radiographic progression (soft tissue disease by RECIST v1.1 criteria or two or more documented new bone lesions on a bone scan ) 7. PSMA PET/CT demonstrating uptake intensity significantly greater than liver at sites of disease 8. Surgically or medically castrated, with testosterone levels of less than 50 ng/dL (less than 2.0 nM). If the patient is being treated with LHRH agonists (patient who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to Cycle 1 Day 1 and must be continued throughout the study. 9. Eastern Cooperative Oncology Group (ECOG) Performance Status of less than 2 10. Life expectancy greater than 12 weeks. 11. Written informed consent
Exclusion criteria
1. Estimated GFR less than 40 ml/min 2. Platelet count less than 75,000 x109 /L 3. Neutrophil count less than 1.5 x109 /L 4. Hb less than 9.0 g/dL 5. Albumin at least 25 6. Hydronephrosis with ureteric obstruction 7. Concomitant nephrotoxic drugs (e.g. aminoglycosides) 8. FDG PET/CT demonstrating sites of major discordant disease (i.e. FDG + PSMA-) 9. Recent radiotherapy (within 6 weeks) to sole sites of assessable disease 10. Uncontrolled inter-current illness that would limit compliance with study protocols
Outcome results
None listed