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A randomised, multi-centre, intra-patient imaging and dosimetry crossover study of lutetium (177Lu) rhPSMA-10.1 and lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with non-curative metastatic prostate cancer

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515264-31-00
Acronym
BET-PSMA-001
Enrollment
18
Registered
2025-03-03
Start date
2025-04-15
Completion date
2025-08-14
Last updated
2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PSMA-positive non-curative metastatic castration-resistant prostate cancer

Brief summary

1. The primary endpoint of the study is the ratio of tumour to kidney absorbed dose ratios (i.e. the ratio of the therapeutic indices).

Detailed description

1. The absorbed dose delivered to the tumours for lutetium (177Lu) rhPSMA-10.1 compared with lutetium (177Lu) vipivotide tetraxetan., 2. The ratio of tumour to normal organ absorbed dose ratios. Organs of interest include the salivary glands and bone marrow., 3. Tumour retention of lutetium (177Lu) rhPSMA-10.1 compared with lutetium (177Lu) vipivotide tetraxetan. Note: Retention will be measured as the tumour effective half-life., 4. Normal organ retention of lutetium (177Lu) rhPSMA-10.1 compared with lutetium (177Lu) vipivotide tetraxetan. Note: Retention will be measured as the normal organ effective half-life., 5. Frequency and nature of treatment-emergent adverse events (TEAEs).

Interventions

DRUGPluvicto 1 000 MBq/mL solution for injection/infusion
DRUGLutetium (177Lu) rhPSMA-10.1 injection

Sponsors

Blue Earth Therapeutics Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. The primary endpoint of the study is the ratio of tumour to kidney absorbed dose ratios (i.e. the ratio of the therapeutic indices).—

Secondary

MeasureTime frame
1. The absorbed dose delivered to the tumours for lutetium (177Lu) rhPSMA-10.1 compared with lutetium (177Lu) vipivotide tetraxetan., 2. The ratio of tumour to normal organ absorbed dose ratios. Organs of interest include the salivary glands and bone marrow., 3. Tumour retention of lutetium (177Lu) rhPSMA-10.1 compared with lutetium (177Lu) vipivotide tetraxetan. Note: Retention will be measured as the tumour effective half-life., 4. Normal organ retention of lutetium (177Lu) rhPSMA-10.1 compared with lutetium (177Lu) vipivotide tetraxetan. Note: Retention will be measured as the normal organ effective half-life., 5. Frequency and nature of treatment-emergent adverse events (TEAEs).—

Countries

France, Germany, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026