NCT06220188

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer Recurrent

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-01-15
• Primary completion: 2026-06-01
• Completion: 2027-01-01
• First posted: 2024-01-23
• Last updated: 2024-02-13

Locations

1 site across 1 country: Austria