Leuprolide Acetate or Goserelin Acetate With or Without Vismodegib Followed by Surgery in Treating Patients With Locally Advanced Prostate Cancer

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Leuprolide and Goserelin.

Antihormone therapy, such as leuprolide acetate or goserelin acetate, may lessen the amount of androgens made by the body.

It had two arms (groups): Arm I (leuprolide acetate, goserelin acetate, vismodegib) (experimental) and Arm II (leuprolide acetate, goserelin acetate) (active comparator).

Patients receive LHRH analogue comprising leuprolide acetate IM or goserelin acetate SC on day 1 and vismodegib PO QD on days 1-28. Treatment repeats every 28 days for up to 16 weeks in the absence of disease progression or unacceptable toxicity.

Patients receive LHRH analogue comprising leuprolide acetate or goserelin acetate as in Arm I. Treatment repeats every 28 days for up to 16 weeks in the absence of disease progression or unacceptable toxicity.

The registry classes the interventions as drug and other.

More on the Plan

To assess safety of preoperative GDC-0449 (vismodegib) in combination with luteinizing hormone-releasing hormone (LHRH).

To assess the difference in proportion of patients with negative disease surgical margins between the two arms.

To collect and archive tissue from the primary tumor, bone marrow and blood (serum, plasma), bone marrow aspirate for future study.

To assess difference in relapse rate (biochemical, objective) and time to progression.

Who Took Part

The registry lists 10 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: Patients must have histologic proof of prostatic adenocarcinoma via a minimum of 6 core biopsy samples. Clinical stage T1c or T2 with high-grade disease (Gleason's 8-10) on initial biopsy and prostate specific antigen (PSA) \> 10 ng/ml, or clinical stage T2b-T2c with Gleason's grade \>= 7. No evidence of metastatic disease as determined by imaging. Initial therapy with antiandrogen treatment is allowed but must be within 4 weeks prior to study enrollment. Absence of major co-morbidity as determined by the treating physician.

The full record lists 15 inclusion and 15 exclusion criteria; among the exclusions: histologic variants in the primary tumor (histologic variants other than adenocarcinoma); patients who have received prior treatment with gdc-0449; patients may not be receiving any other investigational agents.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

The Leuprolide group and the comparison group ran side by side rather than switching.

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.

It started in 2010-07-09 with completion listed for 2012-06-01.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Leuprolide and Goserelin in 10 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 and the Goserelin compound page, all human trials.