Radionuclide therapy using Lutetium-177 prostate specific membrane antigen (PSMA): a pilot study in men with castrate-resistant prostate cancer (LuPSMA trial)

Phase 1

Completed

• Conditions: Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12615000912583
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of therapy as determined by quality of life scores (determined using quality of life questionnaire (EORTC-Q30)[3 months following completion of therapy];Efficacy of therapy as determined by pain scores (determined using pain questionnaire EORT-BM22 / BPI-SF)[3 months post completion of therapy];Efficacy of therapy as determined as determined by imaging response (bone scan, CT, PSMA and FDG PET/CT) (using PCWG4 criteria)[3 months post completion of therapy<br>]

Secondary Outcome Measures

Name	Time	Method
Efficacy of therapy as determined as determined by serum PSA (primart outcome)[3 months post completion of therapy];Toxicity of therapy (primary outcome)[- clinical assessment prior to each administration of LuPSMA, 6 weeks and 12 weeks following completion of therapy<br>- vital signs following each administration of LuPSMA<br>- blood tests (full blood count, urea and electrolytes, liver function tests) 14 and 28 days after each administration of LuPSMA<br>- telephone follow-up at 14 and 28 days after each administration of LuPSMA];Normal tissue and tumour dosimetry expressed in cGy[Determined using voxel-based quantitative SPECT/CT imaging for each cycle of LuPSMA therapy];Progression free survival determined from date of commencement of PSMA therapy[During follow-up period <br>- determined using clinical review (up to 1 year)];Overall survival[During follow-up period<br>- determined using clinical review (up to 1 year)]