RecruitingPhase 2NCT06220188

PSMA-RLT in Biochemically Recurrent PCa

[177Lu]Lu-PSMAI&T Radioligand Therapy (PSMA-RLT) for Patients With Prostate Cancer and Biochemical But Not Radio-morphological Local Recurrence After Primary Therapy With Curative Intent: A Prospective Phase II Pilot Study


Sponsor

Medical University of Vienna

Enrollment

20 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Prospective 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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing PSMA-targeted radioligand therapy (PSMA-RLT) — a treatment that delivers targeted radiation directly to prostate cancer cells — in men whose prostate-specific antigen (PSA) level is rising after both surgery and radiation therapy for prostate cancer, even though no local recurrence is visible on scans. **You may be eligible if...** - You have prostate cancer with a rising PSA after both radical prostatectomy and radiation therapy - Your PSA doubling time is 12 months or less (rising quickly) - You have not been on hormone therapy in the past 12 months, or your testosterone has recovered - Your PSMA PET scan shows no local recurrence (distant spread is allowed) - You are in good overall health (ECOG 0–1) with adequate kidney and blood counts **You may NOT be eligible if...** - You are currently in another interventional clinical trial - You have severe urinary obstruction or unmanageable urinary leakage - You have a short life expectancy (less than one year) due to other serious conditions - You have significant psychiatric or physical conditions that would interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[177Lu]Lu-PSMA I&T

2 cycles (3 GBq in first cycle and 6 GBq in the second cycle) of \[177Lu\]Lu-PSMAI\&T radioligand therapy at 6-week intervals


Locations(1)

Medical University of Vienna

Vienna, Austria

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NCT06220188


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