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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04647526 | Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment | PHASE3 | ACTIVE NOT_RECRUITING | 455 | — | — | Feb 25, 2021 | Mar 1, 2028 | Jan 13, 2026 | 54 | United States, Canada +4 |
* rPFS, as assessed by blinded independent central review (BICR), is the time from the randomization date to progression on soft tissue per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or confirmed progression on bone lesions by Prostate Cancer Working Group 3 (PCWG3) criteria, or death from any cause. * The date of disease progression is the date of the scan for the first objectively documented progressive disease (PD) per RECIST v1.1 or PCWG3. PD is defined as a ≥20% increase in the sum of the diameters of target lesions (≥5 mm absolute), with reference being the smallest sum in the study, or unequivocal progression of non-target lesions, or appearance of new lesions. * Participants who do not progress, including those who started new anticancer therapy, withdrew from the study, or were lost to follow-up without disease progression, were censored at the last valid assessment for RECIST v1.1 or PCWG3.
| Arm | Type | Description |
|---|---|---|
| Lead-in Dosimetry Phase: [Lu-177]-PNT2002 | EXPERIMENTAL | Participants received 6.8 gigabecquerels (GBq) (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles. |
| Randomization Phase: [Lu-177]-PNT2002 (Arm A) | EXPERIMENTAL | Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles. |
| Randomization Phase: Abiraterone or Enzalutamide (Arm B) | ACTIVE_COMPARATOR | Participants received either of below treatments until radiographic progression. * Enzalutamide 160 milligram (mg) orally once daily (or) * Abiraterone 1000 mg orally once daily coadministered with prednisone 5 mg orally twice daily or dexamethasone 0.5 mg orally once daily. Participants who experienced radiographic progression per Blinded Independent Central Review (BICR) (or after final overall survival (OS), per local investigator-assessment), had not started an intervening treatment, and had no uncontrolled adverse events (AEs) were eligible to consent to cross over to receive 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 intravenous infusion every 8 weeks for 4 cycles. |
| Pharmacokinetic (PK) Extension Phase: [Lu-177]-PNT2002 | EXPERIMENTAL | Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles. |
| Name | Type | Description |
|---|---|---|
| [Lu-177]-PNT2002 | DRUG | Participants randomized to Arm A will receive 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 every 8 weeks for 4 cycles |
| Abiraterone | DRUG | Abiraterone (1000 mg orally once daily with: 5 mg twice daily prednisone or 0.5 mg once daily dexamethasone) |
| Enzalutamide | DRUG | Enzalutamide (160 mg orally once daily) |
Inclusion Criteria: 1. Male aged 18 years or older. 2. Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. 3. Ineligible or averse to chemotherapeutic treatment options. 4. Patients must have progressive mCRPC at the time of consent based on at least 1 of ...