At a glance
ClinicalIndex Comparison Record- ✓Metastatic castration-resistant prostate cancer with PSA rise of ≥0.2 ng/mL on at least 2 separate occasions >1 week apart while on abiraterone or enzalutamide
- ✓ECOG performance status 0-2
- ✓Adequate liver function: AST and ALT <2.5 × ULN; total bilirubin <1.5 × ULN
- ✓Adequate bone marrow function: platelets >60,000; hemoglobin >8.5 g/dL
- ✕Non-PSA producing prostate cancers (e.g., small cell prostate cancer) or radiographic progression without PSA rise
- ✕Inability to tolerate standard doses of abiraterone (1000 mg daily) or enzalutamide (160 mg daily)
- ✕Prior exposure to TRC105 or any CD105-targeted antibody
- ✕Uncontrolled chronic hypertension: systolic >150 mmHg or diastolic >90 mmHg despite optimal therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Study of TRC105 (Anti-endoglin Antibody) With Abiraterone and With Enzalutamide in Metastatic, Castration Resistant Prostate Cancer Patients Progressing on Therapy
In Brief
A Phase 2 clinical trial evaluating TRC105, Abiraterone, and 1 other intervention for Prostate Cancer. Completed, enrolled 11 participants across 1 site.
Detailed Summary
This research study is being done to measure the clinical benefit of TRC105 in combination with abiraterone or enzalutamide in metastatic, castration-resistant prostate cancer patients who are taking either abiraterone or enzalutamide and showing signs of biochemical progression without radiographic progression. A patient who is progressing on AR-therapy will continue the same AR-therapy on study with the addition of TRC105. The two arms will accrue in parallel and independently.
Study Details
Timeline
Interventions
Patients will receive TRC105 10mg weekly x 4, and then 15 mg/kg every 2 weeks
Patients who are progressing on Abiraterone will undergo a washout period and then continue treatment with standard dosing of Abiraterone plus TRC105.
Patients who are progressing on Enzalutamide will undergo a washout period and then continue standard treatment with Enzalutamide plus TRC105.