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OncoMatch/Clinical Trials/NCT06220188

PSMA-RLT in Biochemically Recurrent PCa

Is NCT06220188 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies [177Lu]Lu-PSMA I&T for prostate cancer recurrent.

Phase 2RecruitingMedical University of ViennaNCT06220188Data as of Jun 2026Location: Austria

Treatment: [177Lu]Lu-PSMA I&TProspective single-center one-arm phase II study in patients with prostate cancer and confirmed biochemical recurrence (BCR) with PSA of ≥ 0.2 ng/ml after radical prostatectomy (RP) or PSA \> nadir + 2ng/ml after radiotherapy (RT) but not radio-morphological local recurrence after primary therapy with curative intent receive systemic therapy with only 2 cycles of highly standardized (3 GBq in first cycle and 6 GBq in the second cycle) PSMA-RLT at 6-week intervals.

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Extracted eligibility criteria

Treatments studied

Other

[177Lu]Lu-PSMA I&T

Cancer type

Prostate Cancer

Biomarker criteria

Required: FOLH1 PSMA PET negative for local recurrence

PSMA PET negative result for local recurrence

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 80
Male only

Prior therapy

Must have received: radical prostatectomy

biochemical recurrence after radical prostatectomy

Must have received: radiotherapy

biochemical recurrence after...radiotherapy

Cannot have received: hormonal therapy

Exception: no hormonal therapy within the last 12 months or recovered testosterone levels

No hormonal therapy within the last 12 months or recovered testosterone levels

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 NCT06220188 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior hormonal therapy disqualifies patients from enrollment.

Does this trial require FOLH1?

Yes, FOLH1 PSMA PET negative for local recurrence is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 80 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.

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