A new Phase 2 clinical trial of tesetaxel in men with castrate resistant advanced prostate cancer will be conducted through the Prostate Cancer Clinical Trials Consortium (PCCTC). Tesetaxel, an oral taxane which is in clinical development, will be evaluated for its use as both first- and second-line chemotherapy.

The Prostate Cancer Clinical Trials Consortium (PCCTC), which is comprised of 13 leading academic centers focused on prostate cancer research. Memorial Sloan-Kettering Cancer Center, a member of the consortium, will act as the coordinating institution and is the first site to open for enrollment.  Funding for the PCCTC is provided by the Department of Defense Prostate Cancer Research Program (DOD) and the Prostate Cancer Foundation.

The trial will evaluate two discrete populations: men who have advanced prostate cancer that is hormone/castrate-resistant who have not previously received chemotherapy; and men who have developed progressive disease after having received at least 3 cycles of docetaxel chemotherapy.

A two-stage design will be employed for each cohort, and a maximum of 96 subjects are projected to be accrued. The primary endpoint is the estimation of the proportion of patients in each cohort who have not progressed for at least 6 months (i.e., 6-month progression-free survival). Accrual is expected to complete within 12 months.

The two standard taxanes that are currently approved in the U.S. for advanced prostate cancer are associated with significant side effects. Docetaxel (Taxotere®) is approved for first-line use in chemotherapy-naive patients with castrate-resistant disease, and cabazitaxel (Jevtana®) is approved for men who have progressed on docetaxel.

Tesetaxel, the investigational drug,  is given orally  in a capsule  as opposed to both Taxotere and Jevtana which are given by IV injection.  Compared with these drugs, clinical and preclinical data show that tesetaxel:

* Is active in diseases that are resistant to standard taxanes
* Is not associated with serious (occasionally fatal) hypersensitivity reactions
* Eliminates requirements for pre-medication (e.g., steroids, antihistamines, etc.)
* Reduces damage to peripheral nerves
* Offers flexible and convenient dosing for patients

It is too early to say that  Tesetaxel is “on the horizon,” bit I do feel that it warrants close observation going forward.

Joel T Nowak, M.A., M.S.W.