Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Trial acronym
LuPSMA Trial
Clinical summary
Summary
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
Conditions
This trial is treating people with prostate cancer
Eligibility
Inclusion
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
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
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Peter MacCallum Cancer Centre
Scientific Title
For men with metastatic prostate cancer refractory to hormonal and chemotherapy, what is the efficacy and toxicity of radionuclide therapy with Lutetium-177 PSMA
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