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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05146973




Registration number
NCT05146973
Ethics application status
Date submitted
25/11/2021
Date registered
7/12/2021

Titles & IDs
Public title
External Beam Therapy With Theranostic Radioligand Therapy for Oligometastatic Prostate Cancer (ProstACT TARGET)
Scientific title
A Single Arm, Phase 2 Trial of External Beam Radiation Therapy (EBRT) in Combination With 177Lu-DOTA-TLX591-CHO in Patients With Biochemically Recurrent Oligometastatic, Prostate Specific Membrane Antigen-Expressing Prostate Cancer
Secondary ID [1] 0 0
ProstACT TARGET
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 177Lu-DOTA-TLX591

Experimental: Single administration of 177Lu-DOTA-TLX591 - Two single IV infusions of 76 mCi (2.8 GBq) each (equivalent to a 45 mCi/m2 administered activity in a standard 1.7m2 individual) of 177Lu-DOTA-TLX591, given 14 days apart.


Treatment: Other: 177Lu-DOTA-TLX591
TLX591, a monoclonal antibody conjugated with a DOTA chelator and radiolabelled with 177Lu (177Lu-DOTA-TLX591)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine Prostate Specific Antigen Progression Free Survival (PSA PFS)
Timepoint [1] 0 0
Through study completion, up to 2 years

Eligibility
Key inclusion criteria
* Signed Informed Consent Form
* Male, aged = 18 years
* Estimated life expectancy of at least 6 months
* Eastern Cooperative Oncology Group (ECOG) score 0 - 2
* Biopsy proven prostate adenocarcinoma with Gleason Score 7 or more at primary presentation
* Previous Radical Prostatectomy (RP) with curative intent (+/- post-operative radiotherapy to prostate bed)
* Biochemical relapse, as defined by EAU-ESTRO-SIOG Guidelines (serum PSA > 0.2 ng/mL, confirmed by repeat measurements)
* PSMA-ligand avid pelvic nodal disease on PSMA-ligand PET/CT, with visualised disease confined to the pelvis with or without evidence of PSMA-avid disease in the prostate bed
* At least one pelvic nodal lesion = 5 mm in the greatest dimension. SUVmax > 9 in enlarged nodes; SUVmax > 3 in nodes 5 mm or less
* Oligometastatic disease as defined by = 5 metastatic lymph nodes
* Metastatic lymph nodes not beyond the aortic bifurcation
* Non-castrate levels of testosterone (> 20 ng/dL)
* Chemotherapy naïve
* Adequate renal function: Cr Cl = 40 mL/min (determined by Cockcroft-Gault formula)
* Adequate bone marrow function: Hb > 90 g/L; platelets > 100 x 109/L; neutrophils > 1.5 x 109/L
* Adequate liver function: bilirubin < 1.5 x upper limit of normal (ULN); AST, ALT, ALP < 2 x ULN; albumin > 30 g/L
* Willing and able to comply with all trial requirements, including all treatments and pre- and post-treatment assessments
* Able to commence treatment within 28 days of enrolment
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous external beam radiotherapy to pelvis for other malignancies or medical conditions (except for post-operative prostate bed radiotherapy for prostate cancer)
* Androgen deprivation therapy within 12 months of trial screening
* Known androgen deficiency
* Bone or visceral metastases
* Lymph node metastases above the aortic bifurcation
* Contraindications to pelvic irradiation as determined by Investigator (e.g., chronic inflammatory bowel disease)
* At increased risk of haemorrhage, or recent history of a thrombotic event (e.g., Deep Vein Thrombosis [DVT]/Pulmonary Embolism [PE]) and/or are using long-term anti-coagulant or anti-platelet agents)
* Known hypersensitivity to any isotope of lutetium (Lu) in any chemical form, or any isotope used in PSMA imaging
* Contraindication to intravenous contrast
* Evidence of urinary tract stricture, or significant urinary/faecal incontinence Presence of active infection at time of screening, or history of serious infection within the previous 4 weeks
* History of any malignancy other than prostate cancer within 5 years of enrolment (excluding localised non-melanoma skin cancers)
* Any uncontrolled significant medical, psychiatric, or surgical condition (e.g., active infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled type 2 diabetes, uncontrolled congestive heart failure, pulmonary disease), or laboratory findings that, in the opinion of the Investigator, may jeopardise the participant's safety or that would limit compliance with the treatment and assessment requirements of the trial
* Any cognitive impairment or other condition that may render the participant unable to adequately understand the requirements, nature, and possible consequences of the trial.
* Intention to father children within a timeframe corresponding with the duration of the allocated treatment regime plus 12 weeks.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/03/2024
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
GenesisCare North Shore - St Leonards
Recruitment hospital [2] 0 0
GenesisCare Murdoch - Perth
Recruitment hospital [3] 0 0
GenesisCare St Andrews - Adelaide
Recruitment hospital [4] 0 0
GenesisCare Tugun - Tugun
Recruitment postcode(s) [1] 0 0
- St Leonards
Recruitment postcode(s) [2] 0 0
6150 - Perth
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
4225 - Tugun

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Telix Pharmaceuticals (Innovations) Pty Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05146973