OncoMatch

OncoMatch/Clinical Trials/NCT06259123

Neoadjuvant PSMA-RLT in Oligometastatic PCa

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

Phase 2RecruitingMedical University of ViennaNCT06259123Data as of Jun 2026Location: Austria

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.

Check if I qualify

Extracted eligibility criteria

Treatments studied

Other

[177Lu]Lu-PSMA I&T

Cancer type

Prostate Cancer

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75
Male only

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.

Frequently asked questions

Is NCT06259123 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Is this trial open to female patients?

No. This trial enrolls male patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify