Prostate CancerPhase 2NCT05146973
External Beam Therapy With Theranostic Radioligand Therapy for Oligometastatic Prostate Cancer (ProstACT TARGET)
A Phase 2 study testing 177Lu-DOTA-TLX591 in people with Prostate Cancer, run by Telix Pharmaceuticals (Innovations) Pty Limited at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 177Lu-DOTA-TLX591
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 4 sitesAustralia
- Study dates
- 30 Aug 2022to 24 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
GenesisCare St Andrews
Adelaide, 5000
GenesisCare Murdoch
Perth, Western Australia, 6150
GenesisCare North Shore
St Leonards, New South Wales
GenesisCare Tugun
Tugun, 4225
About this study
Official 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
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.
- Conditions
- Prostate Cancer
- Being tested
- 177Lu-DOTA-TLX591
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-DOTA-TLX591Biological
TLX591, a monoclonal antibody conjugated with a DOTA chelator and radiolabelled with 177Lu (177Lu-DOTA-TLX591)
| Study group | Role | What they receive |
|---|---|---|
| Single administration of 177Lu-DOTA-TLX591 | Experimental | 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. Receives: Biological: 177Lu-DOTA-TLX591 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine Prostate Specific Antigen Progression Free Survival (PSA PFS)
The time from enrolment to time of PSA increase greater than 25%
Measured: Through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start30 Aug 2022
- Primary completion30 Jul 2023
- Study completion24 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146973
- Sponsor's protocol ID
- ProstACT TARGET
- Status last verified
- Dec 2024
- First submitted
- 25 Nov 2021
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05146973
- Acronym / sponsor ID
- ProstACT TARGET
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 24 Mar 2024 (actual)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single administration of 177Lu-DOTA-TLX591 | Experimental | Biological: 177Lu-DOTA-TLX591Two 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 177Lu-DOTA-TLX591TLX591, a monoclonal antibody conjugated with a DOTA chelator and radiolabelled with 177Lu (177Lu-DOTA-TLX591) | Biological | Single administration of 177Lu-DOTA-TLX591 |
Primary outcome
To determine Prostate Specific Antigen Progression Free Survival (PSA PFS)
Time frame: Through study completion, up to 2 years
The time from enrolment to time of PSA increase greater than 25%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 177Lu-DOTA-TLX591 in people with Prostate Cancer, run by Telix Pharmaceuticals (Innovations) Pty Limited at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine Prostate Specific Antigen Progression Free Survival (PSA PFS) (time frame: Through study completion, up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.