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Trial registered on ANZCTR


Registration number
ACTRN12615000912583
Ethics application status
Approved
Date submitted
21/07/2015
Date registered
2/09/2015
Date last updated
9/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Radionuclide therapy using Lutetium-177 prostate specific membrane antigen (PSMA): a pilot study in men with castrate-resistant prostate cancer (LuPSMA trial)
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
Secondary ID [1] 287130 0
Nil
Universal Trial Number (UTN)
U1111-1172-4095
Trial acronym
LuPSMA Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 295668 0
Condition category
Condition code
Cancer 295945 295945 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 292381 0
Treatment: Other
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295624 0
Efficacy of therapy as determined by quality of life scores (determined using quality of life questionnaire (EORTC-Q30)
Timepoint [1] 295624 0
3 months following completion of therapy
Primary outcome [2] 295953 0
Efficacy of therapy as determined by pain scores (determined using pain questionnaire EORT-BM22 / BPI-SF)
Timepoint [2] 295953 0
3 months post completion of therapy
Primary outcome [3] 295954 0
Efficacy of therapy as determined as determined by imaging response (bone scan, CT, PSMA and FDG PET/CT) (using PCWG4 criteria)
Timepoint [3] 295954 0
3 months post completion of therapy
Secondary outcome [1] 317016 0
Efficacy of therapy as determined as determined by serum PSA (primart outcome)
Timepoint [1] 317016 0
3 months post completion of therapy
Secondary outcome [2] 317017 0
Toxicity of therapy (primary outcome)
Timepoint [2] 317017 0
- clinical assessment prior to each administration of LuPSMA, 6 weeks and 12 weeks following completion of therapy
- vital signs following each administration of LuPSMA
- blood tests (full blood count, urea and electrolytes, liver function tests) 14 and 28 days after each administration of LuPSMA
- telephone follow-up at 14 and 28 days after each administration of LuPSMA
Secondary outcome [3] 317018 0
Normal tissue and tumour dosimetry expressed in cGy
Timepoint [3] 317018 0
Determined using voxel-based quantitative SPECT/CT imaging for each cycle of LuPSMA therapy
Secondary outcome [4] 317019 0
Progression free survival determined from date of commencement of PSMA therapy
Timepoint [4] 317019 0
During follow-up period
- determined using clinical review (up to 1 year)
Secondary outcome [5] 317020 0
Overall survival
Timepoint [5] 317020 0
During follow-up period
- determined using clinical review (up to 1 year)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4072 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment postcode(s) [1] 10020 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 291688 0
Government body
Name [1] 291688 0
Australian Nuclear Science and Technology Organisation (ANSTO)
Address [1] 291688 0
New Illawarra Road, Lucas Heights, New South Wales 2234
Country [1] 291688 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Locked Bag 1
A'Beckett Street
East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 290399 0
None
Name [1] 290399 0
None
Address [1] 290399 0
None
Country [1] 290399 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293215 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 293215 0
Level 4, 10 St Andrews Place
East Melbourne, VIC 3002
Ethics committee country [1] 293215 0
Australia
Date submitted for ethics approval [1] 293215 0
Approval date [1] 293215 0
24/07/2015
Ethics approval number [1] 293215 0
15/66

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58938 0
A/Prof Michael Hofman
Address 58938 0
Peter MacCallum Cancer Centre
7 St Andrews Place
East Melbourne VIC 3002
Country 58938 0
Australia
Phone 58938 0
+61396561854
Fax 58938 0
Email 58938 0
michael.hofman@petermac.org
Contact person for public queries
Name 58939 0
A/Prof Michael Hofman
Address 58939 0
Peter MacCallum Cancer Centre
7 St Andrews Place
East Melbourne VIC 3002
Country 58939 0
Australia
Phone 58939 0
+61396561854
Fax 58939 0
Email 58939 0
michael.hofman@petermac.org
Contact person for scientific queries
Name 58940 0
A/Prof Michael Hofman
Address 58940 0
Peter MacCallum Cancer Centre
7 St Andrews Place
East Melbourne VIC 3002
Country 58940 0
Australia
Phone 58940 0
+61396561854
Fax 58940 0
Email 58940 0
michael.hofman@petermac.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary