External Beam Therapy With Theranostic Radioligand Therapy for Oligometastatic Prostate Cancer (P… (NCT05146973) | Clinical Trial Compass
CompletedPhase 2
External Beam Therapy With Theranostic Radioligand Therapy for Oligometastatic Prostate Cancer (ProstACT TARGET)
Australia5 participantsStarted 2022-08-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
E…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine Prostate Specific Antigen Progression Free Survival (PSA PFS)
Timeframe: Through study completion, up to 2 years