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 range18 Years
SexMALE
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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…
What they're measuring
1
To determine Prostate Specific Antigen Progression Free Survival (PSA PFS)
Timeframe: Through study completion, up to 2 years