Neoadjuvant Estradiol or Androgen Deprivation in Clinically Localized Prostate Cancer

What Was Tested

This registered phase 2 trial tested Leuprolide and Goserelin.

Prostate cancer is the most commonly diagnosed cancer among males in the U.S.

More than 220,000 men will be diagnosed with prostate cancer in the USA this year and more that 31,000 will die of this disease.

It had two arms (groups): A (active comparator) and B (experimental).

The registry classes the interventions as drug.

More on the Plan

One hypothesis is that estrogens modulate immunity to prostate cancer through direct activation of effector cells and by upregulating cytokines in prostatic stroma.

Administration of estrogen in murine models induces infiltration of normal prostate with T lymphocytes even in castrate male animals potentially through induction of autoimmunity to normally cryptic prostate antigens.

The researchers propose to test the hypothesis that administration of estrogen and/or androgen deprivation induces immune recognition of prostate cancer in humans through upregulation of major histocompatibility antigens on tumor and induction of tumor specific immunity.

The specificity of estrogen effect will be tested by comparing measures of immunity in patients treated with estradiol, androgen deprivation or no neoadjuvant therapy.

Who Took Part

Enrollment: 17 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: Men 18 years or older with a histologic diagnosis of low to intermediate risk prostate cancer prior to radical prostatectomy as defined by:. Clinical stage T1-T2b. PSA \< 20. Gleason score \< 7. Patient's tumor must be considered surgically resectable as determined by a urologic evaluation.

The full record lists 9 inclusion and 14 exclusion criteria; among the exclusions: patients with locally advanced or high-risk disease as defined above; patients who have a testosterone less than 280 ng/dl; patients who have evidence of cerebrovascular accident or ischemia, recent deep venous thrombosis, pulmonary emboli, unstable angina or clinical congestive heart failure.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2005-03 with completion listed for 2006-12.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The primary endpoint of the study is to evaluate the induction of tumor and prostate-specific immunity by androgen deprivation and estradiol administration (time frame: End of Study).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide and Goserelin in 17 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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