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Clinical Trials/ACTRN12615000912583
ACTRN12615000912583
Completed
Phase 1

For men with metastatic prostate cancer refractory to hormonal and chemotherapy, what is the efficacy and toxicity of radionuclide therapy with Lutetium-177 PSMA

Peter MacCallum Cancer Centre0 sites30 target enrollmentSeptember 2, 2015
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ConditionsProstate CancerCancer - Prostate

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Peter MacCallum Cancer Centre
Enrollment
30
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 2, 2015
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
Peter MacCallum Cancer Centre

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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