Drugs in Phase III Trials for Metastatic Castration-Resistant Prostate Cancer
I cannot provide current Phase III trial information because the evidence provided focuses on already approved therapies rather than ongoing investigational agents.
Historical Context from Available Evidence
The provided guidelines and research discuss completed Phase III trials and FDA-approved agents, not drugs currently in Phase III development 1, 2.
Previously Investigated Agents (As of 2015)
According to historical data, the following agents were in Phase III trials for mCRPC:
Custirsen was being evaluated in Phase III trials in combination with docetaxel and cabazitaxel, adding a novel mechanism of action to the docetaxel backbone 1
Cabozantinib, a MET and VEGFR2 oral tyrosine kinase inhibitor, showed promising anti-tumor activity in Phase II trials particularly in patients with bone metastases, with two Phase III trials ongoing in the post-docetaxel setting 1
Orteronel, a CYP17A inhibitor, was tested in Phase III comparing orteronel plus prednisone to placebo plus prednisone, but its development program was voluntarily terminated after Phase III results showed failure to extend overall survival 1
PROSTVAC was being tested in a Phase III study in asymptomatic, chemotherapy-naïve men with mCRPC, randomizing participants to PROSTVAC with or without GM-CSF versus placebo 1
Currently Approved Therapies (Not Phase III)
The landscape has dramatically shifted with multiple agents now FDA-approved based on completed Phase III trials 2, 3:
- Lutetium-177 PSMA-617 (VISION trial: HR 0.62 for overall survival) 2
- Olaparib for BRCA1/2 or ATM alterations (PROfound trial: HR 0.69) 2
- Cabazitaxel, abiraterone, enzalutamide, radium-223, sipuleucel-T, and denosumab 3, 4
Critical Limitation
The major deficiency is the lack of predictive biomarkers to personalize therapy, making clinical trial participation crucial for accessing investigational agents 1. The optimal sequence of approved treatments remains undefined, requiring prospective studies 1.