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 PSMA positive, hormone refractory and progressive prostate cancer. Study details Participants will receive up to six 42-day cycles, with each cycle requiring a single intravenous injection of a radioactive substance called therapeutic 177 Lu-PSMA combined with NOX66. NOX66 is used to make cancer cells more sensitive to radiation treatment and is continued to be given the following 9 days after injection. 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 and Noxopharm Ltd. This will allow you to have the LuPSMA / NOX66 treatment free of charge and for the conduct of the research.
Interventions
This an open label non-randomised phase I/II study in men with prostate specific membrane antigen (PSMA) positive, hormone refractory, progressive prostate cancer present within the preceding 6 months based on radiology and or symptomatic progression.
There are three cohorts which will receive up to six cycles of therapeutic 177 Lu-PSMA combined with either idronoxil 400 mg daily, idronoxil 800 mg daily or idronoxil 1200 mg daily depending on patient response. Enrolment into the higher dose lev
This an open label non-randomised phase I/II study in men with prostate specific membrane antigen (PSMA) positive, hormone refractory, progressive prostate cancer present within the preceding 6 months based on radiology and or symptomatic progression. There are three cohorts which will receive up to six cycles of therapeutic 177 Lu-PSMA combined with either idronoxil 400 mg daily, idronoxil 800 mg daily or idronoxil 1200 mg daily depending on patient response. Enrolment into the higher dose level of idronoxil will only occur after prior cohort is filled and data safety monitoring recommendation to proceed. Each cohort will undergo a 42 day treatment cycle with a single IV injection of 177 Lu-PSMA on day 0 of each cycle. The dose given is calculated by the doctor based on the participant's weight and volume of disease. Dose will vary between individuals. Both cohorts, following administration of 177 Lu-PSMA, will provided with the appropriate idronoxil to self administer at home once a day for the following 9 days. Idronoxil are suppositories and participants will be instructed on the method of administration and provided with instruction sheet. Participants will routinely follow up with treating doctor before each cycle to assess benefit of treatment and adherence to study. Each 42 day cycle will follow the same plan and the participant will continue onto next cycle with .
Sponsors
St Vincent's Hospital Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pathologically confirmed prostate adenocarcinoma 2. Castration-resistant metastatic disease, including prior treatment with Abiraterone, Enzalutamide or both (unless contraindicated, medically unsuitable or patient refuses) 3. Prior Taxane-based chemotherapy (unless contraindicated, medically unsuitable or patient refuses) 4. Objective evidence of disease progression within 6 months of study entry as defined by either: a. Radiologic progression (RECIST v1.1 criteria) on conventional imaging b. Symptoms refractory to standard medical care 5. PSMA PET/CT demonstrating uptake intensity significantly greater than liver at sites of disease 6. Written informed consent.
Exclusion criteria
1. Estimated GFR < 40 ml/min 2. Platelet count <100, 000 x109 /L 3. Neutrophil count < 1.5 x109 /L 4. Hb < 10.0 g/dL 5. Albumin less than or equal to 25 6. Hydronephrosis (untreated) 7. Concomitant nephrotoxic drugs (e.g. aminoglycosides) 8. ECOG performance status > 3 9. Life expectancy of less than 12 weeks 10. Age <18 years 11. FDG PET/CT demonstrating sites of major discordant disease (i.e. FDG + PSMA-) 12. Recent radiotherapy (within 6 weeks) to sole sites of assessable disease 13. Uncontrolled intercurrent illness that would limit compliance with study protocols 14. Unable to comply with study protocol.
Outcome results
None listed