Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer

What Was Tested

The trial (phase 2) is built around Leuprolide.

This trial will investigate the activity of dasatinib plus LHRH analogue therapy in high-risk localized prostate cancer.

It had 1 arm (groups): Single Arm Assignment (experimental).

Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy.

The registry classes the interventions as drug and procedure.

More on the Plan

The 28 days of dasatinib and leuprolide injection (plus the time required to recover from toxicity if encountered) is defined as a cycle.

Patients will be treated for up to a maximum of 3 cycles of dasatinib and leuprolide acetate.

If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.

Who Took Part

1 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Histologically confirmed adenocarcinoma of the prostate. Clinical stage T1-T3a disease. Must be willing to have a tumor biopsy, if previous tumor tissue unavailable for tumor marker analysis. Must be deemed eligible for radical prostatectomy. Written informed consent and HIPAA authorization for release of personal health information.

The full record lists 8 inclusion and 25 exclusion criteria; among the exclusions: no history of hemorrhage or thrombotic events (cerebrovascular accident, deep vein thrombosis, pulmonary embolism, etc.) within 6 months prior to registration for protocol therapy; no history of diagnosed congenital bleeding disorders (e.g., von willebrand's disease); no history of diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor viii antibodies) of registration on protocol therapy.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2009-03 with completion listed for 2010-12.

It ran at 6 sites in United States (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: To Estimate the Pathologic Complete Response (pCR) Rate (time frame: 18 months).

It also tracked 5 secondary outcomes, for example To Estimate Partial Pathologic Responses (pPR), To Estimate PSA Response Rate, To Estimate Progression Free Survival, To Evaluate the Impact of Dasatinib Plus LHRH on Expression of Selected Biomarkers and To Estimate Safety and Tolerability of LHRH Plus Dasatinib.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide in 1 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page, all human trials.