SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer

What Was Tested

The trial (phase 3) is built around Goserelin.

It had two arms (groups): Consolidation arm I (active comparator) and Consolidation arm II (experimental).

The registry classes the interventions as drug and other.

More on the Plan

OUTLINE: This is a randomized, multicenter study.

Patients with rising PSA or progressive disease begin CAD therapy as in induction therapy.

Patients whose PSA normalizes after 8 courses return to observation.

Patients whose PSA does not normalize after 8 courses continue CAD therapy.

Who Took Part

The registry lists 3040 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 or cytologically confirmed adenocarcinoma of the prostate. Metastatic stage IV (stage D2). Any number of bone metastases by bone scan allowed. Unequivocal visceral organ metastases (liver, brain, or lung) allowed. No suspected second primary tumors unless metastases are histologically confirmed, including special stains (e.g., prostate specific antigen \[PSA\] and prostatic alkaline phosphatase \[PAP\]).

The full record lists 33 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

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

It started in 1995-05 with completion listed for 2013-06.

It ran at 14 sites in Canada (14).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Overall Survival (time frame: Up to 15 years). Physical Functioning as Measured by the SF-36 (time frame: 3 months). Emotional Functioning as Measured by the SF-36 Mental Health Inventory (time frame: 3 months).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 3040 people.

With 3040 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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