At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed adenocarcinoma of prostate
- ✓Documented progressive metastatic CRPC per PCWG3 criteria (PSA progression, radiographic progression, or new bone lesions)
- ✓Prior treatment with androgen receptor signaling inhibitor or CYP17 inhibitor
- ✓Prior taxane chemotherapy, ineligible for taxane, or refused taxane
- ✕Investigational medical device implanted ≤4 weeks before treatment or current enrollment in oncologic investigational study
- ✕Investigational drugs ≤4 weeks or <5 half-lives before treatment or current enrollment in investigational oncology study
- ✕Prior systemic beta-emitting bone-seeking radioisotopes (radium-223 allowed if ≥90 days since last dose)
- ✕For PSMA-TRT-naive cohort: prior PSMA-targeted radionuclide therapy not allowed (imaging allowed)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Study of 225Ac-J591 Plus 177Lu-PSMA Small Molecule for Progressive Metastatic Castration Resistant Prostate Cancer
In Brief
A Phase 1 clinical trial evaluating 225Ac-J591, 177Lu-PSMA-617, and 2 other interventions for Prostate Cancer. Currently recruiting, targeting 42 participants across 2 sites.
Detailed Summary
This is a phase I dose-escalation study of 225Ac-J591 administered together with 177Lu-PSMA small molecule. Both drugs are designed to deliver radiation to prostate cancer cells; they are known as radionuclide conjugates (radiation linked to antibodies/molecules that recognize prostate cancer cells). This phase of the study (phase I) will determine the highest dose of the study intervention that can be safely given.
Study Details
Timeline
Interventions
30 - 40 KBq/kg (dose-escalation) every 8 weeks, for up to 2 cycles. Administered together with 177Lu-PSMA-617. Intravenous administration.
6.8 - 7.4 GBq received every 8 weeks, for up to 2 cycles. Administered together with 225Ac-J591. Intravenous administration.
\[185 ±74 MBq or 5 ±2 mCi\] intravenous during screening, 12 weeks, 24 weeks. Imaging agent for PSMA PET/CT.
6.8 GBq received every 8 weeks, up to 2 cycles. Administered together with 225Ac-J591. Intravenous administration.