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OncoMatch/Clinical Trials/NCT06259123

Neoadjuvant PSMA-RLT in Oligometastatic PCa

Is NCT06259123 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies [177Lu]Lu-PSMA I&T for prostate cancer.

Phase 2RecruitingMedical University of ViennaNCT06259123Data as of May 2026

Treatment: [177Lu]Lu-PSMA I&TProspective single-center phase II study to evaluate the PSA, imaging and pathological response, as well as oncological outcomes of systemic radioligand therapy \[177Lu\]Lu-PSMAI\&T (PSMA-RLT) in patients planned for radical prostatectomy (RP) for oligometastatic prostate cancer (PCa) diagnosed using \[68Ga\]Ga-PSMA-11 PET examination. Ten patients with oligometastatic primary PCa diagnosed using \[68Ga\]Ga-PSMA-11 PET-CT/MRI imaging will be included in this study.

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: androgen deprivation therapy

Ongoing or previous androgen deprivation therapy with agonist or antagonist therapies

Lab requirements

Blood counts

WBC ≥1.5 x 10^9 /L, Platelets ≥100 x 10^9 /L and Haemoglobin ≥9 g/dL

Kidney function

eGFR ≥ 50mL/min/1.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of ≥2.5 g/dL

Patients must have adequate bone marrow reserve: WBC ≥1.5 x 10^9 /L, Platelets ≥100 x 10^9 /L and Haemoglobin ≥9 g/dL. Patients must have adequate renal function with eGFR ≥ 50mL/min/1.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of ≥2.5 g/dL.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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