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CompletedLast updated: 30 November 2023

LuPSMA Trial: This phase II trial is evaluating a targeted radiotherapy in men with an advanced prostate cancer that has spread to other parts of the body and is not responding to systemic treatmentFor men with metastatic prostate cancer refractory to hormonal and chemotherapy, what is the efficacy and toxicity of radionuclide therapy with Lutetium-177 PSMA

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 patients with prostate cancer.

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

II

Trial Acronym

LuPSMA Trial

More information

Trial Identifiers

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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

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.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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Completed hospitals

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