Bipolar Androgen-based Therapy for Prostate Cancer (BAT)

What Was Tested

This registered phase 2 trial tested Leuprolide and Goserelin.

It had 1 arm (groups): ADT plus IV testosterone (experimental).

The registry classes the interventions as drug.

More on the Plan

Eligible patients will initiate ADT with Luteinizing hormone-releasing hormone (LHRH) agonist (e.g. goserelin or leuprolide) if not surgically castrated for a total of 6 months.

Patients will then cycle back to ADT only for 12 weeks.

The investigators have termed this rapid cycling between supraphysiologic to low/castrate serum T Bipolar Androgen-based Therapy (BAT).

One BAT cycle will be defined as 24 weeks (i.e. 12 weeks on T; 12 weeks off T).

Who Took Part

The registry lists 33 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: Age ≥ 18 years. Performance status ≤2. Documented histologically confirmed adenocarcinoma of the prostate. No prior treatment with second line hormonal therapies (flutamide, bicalutamide, nilutamide, ketoconazole, abiraterone acetate or MDV3100) is permitted. No prior treatment with chemotherapeutic regimens allowed.

The full record lists 12 inclusion and 9 exclusion criteria; among the exclusions: any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule; no prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to enrollment in the study; abnormal liver function (bilirubin, ast, alt ≥ 3 x upper limit of normal).

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Leuprolide study did not mask who received what.

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

It started in 2013-01 with completion listed for 2015-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Patients With PSA <4 ng/mL at the End of the Study (time frame: 18 months).

It also tracked 6 secondary outcomes, for example Radiographic or Clinical Progression, Complete PSA Response, Change in C-telopeptides, Quality of Life Survey, Change in Weight and Change in Waist Circumference.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide and Goserelin in 33 people.

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

The trial is marked completed; 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.