Prostate Adenocarcinoma TransCutaneous Hormones

What Was Tested

This registered phase 3 trial tested Goserelin for anemia.

An alternative approach is to investigate other methods of ADT.

It had two arms (groups): LHRH agonists (active comparator) and Oestrogen Patches (experimental).

The registry classes the interventions as drug.

More on the Plan

OBJECTIVES: Primary * Compare the progression-free survival and overall survival of patients with locally advanced or metastatic prostate cancer treated with transcutaneous estrogen patches vs luteinizing hormone-releasing hormone analogues.

OUTLINE: This is a randomized, controlled, multicenter study.

Patients' testosterone levels are measured at week 4.

Quality of life is assessed at baseline; at weeks 4, 8, and 12; every 3 months for 24 months.

Who Took Part

2200 planned participants were the target.

It was open to men only aged up to 120 years.

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

Examples of who could join: Must meet 1 of the following criteria:. Newly diagnosed patients with any of the following:. Stage T3 or T4, NX, M0 histologically confirmed prostate adenocarcinoma with prostate-specific antigen (PSA) ≥ 20 ng/mL or Gleason score ≥ 6. Any T, N+, M0, or any T, any N, M+ histologically confirmed prostate adenocarcinoma. Multiple sclerotic bone metastases with a PSA ≥ 50 ng/mL without histological confirmation.

The full record lists 25 inclusion and 0 exclusion criteria.

How the Study Was Run

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

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

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

Nothing was hidden in this open-label Goserelin study: the anemia participants and staff both knew the treatment.

It started in 2006-03 with completion listed for 2021-08.

It ran at 32 sites in United Kingdom (32).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Progression-Free Survival (time frame: Up to 180 months). Overall Survival (time frame: Up to 180 months).

It also tracked 5 secondary outcomes, for example Hormone activity by castrate levels of hormones, Other toxicity, Cardiovascular morbidity, Cardiovascular mortality and Quality of Life.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 2200 people with anemia.

With 2200 participants it is a large trial for this field.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page, Anemia research.