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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05146973
Registration number
NCT05146973
Ethics application status
Date submitted
25/11/2021
Date registered
7/12/2021
Date last updated
2/05/2024
Titles & IDs
Public title
External Beam Therapy With Theranostic Radioligand Therapy for Oligometastatic Prostate Cancer (ProstACT TARGET)
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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
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Secondary ID [1]
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ProstACT TARGET
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - 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.
Other interventions: 177Lu-DOTA-TLX591
TLX591, a monoclonal antibody conjugated with a DOTA chelator and radiolabelled with 177Lu (177Lu-DOTA-TLX591)
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To determine Prostate Specific Antigen Progression Free Survival (PSA PFS)
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Assessment method [1]
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The time from enrolment to time of PSA increase greater than 25%
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Timepoint [1]
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Through study completion, up to 2 years
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/08/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/08/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
5
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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GenesisCare North Shore - St Leonards
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Recruitment hospital [2]
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GenesisCare Murdoch - Perth
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Recruitment hospital [3]
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GenesisCare St Andrews - Adelaide
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Recruitment hospital [4]
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GenesisCare Tugun - Tugun
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Recruitment postcode(s) [1]
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- St Leonards
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Recruitment postcode(s) [2]
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6150 - Perth
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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4225 - Tugun
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Telix Pharmaceuticals (Innovations) Pty Limited
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a phase II trial to evaluate the therapeutic efficacy of a radiolabelled
PSMA-targeting antibody, 177Lu-TLX591, given in combination with external beam radiation
therapy (EBRT) in patients with biochemically recurrent, oligometastatic, PSMA-expressing
prostate cancer. TLX591 is being developed as a PSMA-targeting antibody to be radiolabelled
with a therapeutic radioisotope for the treatment of PSMA-expressing tumours.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05146973
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05146973
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