None listed
Conditions
Brief summary
The primary 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 men with metastatic prostate cancer refractory to hormonal therapy and chemotherapy. Who is it for? You may be eligible to join this study if you have metastatic prostate adenocarcinoma that has progressed despite hormone treatment and chemotherapy. Study details: In this study, we will use a radioactive molecule (called Lutetium-177) that, after injection into vein, specifically attaches to cells with high PSMA Expression. This substance is taken up into prostate cancer cells, wherever they have spread (most often bones or lymph nodes) and enables targeted delivery of high doses of targeted radiation to sites of prostate cancer whilst sparing most normal tissues. This is called radionuclide therapy and uses radiation to kill prostate cancer cells. All participants who pass the screening visit selection will receive this therapy with up to 4 cycles separated by 6 weeks. You will not stay in hospital overnight but several scans will be performed requiring you to come back to the hospital for additional visits. From these scans, we will see where the radiation has gone and also quantify how much radiation was delivered to both tumours and normal tissues. Following treatment you will be mildly radioactive for a few days and there may be some restrictions on close personal contact including with pregnant women or children, but otherwise we anticipate that most patients feel will feel well and be allowed to go home the same day. Overall, participation will require you to visit the hospital approximately 14 times over around 18 months. The drug used in this study is not approved by the Therapeutic Goods Administration (TGA). This study will help inform the efficacy and side effects of LuPSMA in treating metastatic prostate cancer, and design of future larger studies assessing this therapy.
Interventions
Targeted delivery of radiotherapy (radionuclide therapy) with intravenous administration of Lutetium-177 radiolabelled to prostate specific membrane antigen (LuPSMA).
- administered activity of 4-8 GBq, dose adjusted according to tumour burden, patient weight and renal function. LuPSMA administered on day 1 of a 6 week cycle.
- post therapy imaging following each administration of LuPSMA with quantitative SPECT/CT with each cycle to determine radiation dose delivered to tumour and normal tissues
Targeted delivery of radiotherapy (radionuclide therapy) with intravenous administration of Lutetium-177 radiolabelled to prostate specific membrane antigen (LuPSMA). - administered activity of 4-8 GBq, dose adjusted according to tumour burden, patient weight and renal function. LuPSMA administered on day 1 of a 6 week cycle. - post therapy imaging following each administration of LuPSMA with quantitative SPECT/CT with each cycle to determine radiation dose delivered to tumour and normal tissues - further cycles (up to four) will be given if post-therapy imaging demonstrates sufficient uptake to indicate further benefit. Cycles will be separated by 6 weeks
Sponsors
Peter MacCallum Cancer Centre
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. Pathologically confirmed prostate adenocarcinoma 2. Castration-resistant metastatic disease 3. Prior treatment with Abiraterone, Enzalutamide or both (unless contraindicated, medically unsuitable or patient refuses) 4. Prior Taxane-based chemotherapy (unless contraindicated, medically unsuitable or patient refuses) 5. Documented prostate cancer progression within last 12 months as defined by radiographic progression (soft tissue disease by RECIST v1.1 criteria OR two or more documented new metastases on a bone scan) OR new pain in an area of radiographically evident disease 6. PSMA PET/CT demonstrating uptake intensity significantly greater than liver at sites of disease 7. Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 2 8. Life expectancy > 12 weeks
Exclusion criteria
1. Poor kidney function or kidney obstruction (estimated GFR < 40 ml/min, hydronephrosis) 2. Poor blood counts (platelet count < 75,000 x10^9 /L, neutrophil count < 1.5 x 10^9 /L, or Hb < 9.0 g/dL) 3. Poor liver function (albumin <= 25) 4. FDG PET/CT demonstrating sites of major discordant disease (i.e. FDG + PSMA-) 5. Recent radiotherapy (within 6 weeks) to sole sites of assessable disease 6. Uncontrolled intercurrent illness that would limit compliance with study protocols
Outcome results
None listed