Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05146973 | External Beam Therapy With Theranostic Radioligand Therapy for Oligometastatic Prostate Cancer (ProstACT TARGET) | PHASE2 | COMPLETED | 5 | — | — | Aug 30, 2022 | Mar 24, 2024 | Dec 19, 2024 | 4 | Australia |
The time from enrolment to time of PSA increase greater than 25%
| Arm | Type | Description |
|---|---|---|
| Single administration of 177Lu-DOTA-TLX591 | EXPERIMENTAL | Two single IV infusions of 76 mCi (2.8 GBq) each (equivalent to a 45 mCi/m2 administered activity in a standard 1.7m2 individual) of 177Lu-DOTA-TLX591, given 14 days apart. |
| Name | Type | Description |
|---|---|---|
| 177Lu-DOTA-TLX591 | BIOLOGICAL | TLX591, a monoclonal antibody conjugated with a DOTA chelator and radiolabelled with 177Lu (177Lu-DOTA-TLX591) |
Inclusion Criteria: * Signed Informed Consent Form * Male, aged ≥ 18 years * Estimated life expectancy of at least 6 months * Eastern Cooperative Oncology Group (ECOG) score 0 - 2 * Biopsy proven prostate adenocarcinoma with Gleason Score 7 or more at primary presentation * Previous Radical Prostat...