Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer

What Was Tested

In this phase 3 trial, researchers set out to test Leuprolide and Goserelin.

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Antihormone therapy, such as goserelin and leuprolide, may stop the adrenal glands from making androgens.

It had two arms (groups): Arm A: docetaxel + LHRH agonist + surgical intervention (experimental) and Arm B: surgical intervention (other).

All patients undergo standard surgical intervention. The surgical procedures will be performed within 60 days of randomization. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. Adjuvant radiation must be initiated within 6 months of the date of surgery.

The registry classes the interventions as drug and procedure.

More on the Plan

In order to allow the inclusion of these patients in the protocol, enhanced enrollment and maintain compliance with therapy, up to 3 months of androgen deprivation therapy prior to enrollment will be permitted.

OUTLINE: This is a multicenter, randomized study.

Patients are randomized to 1 of 2 treatment arms.

Please see the Arms sections for more details.

Who Took Part

788 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: Histologic documentation - Histologic documentation of prostatic adenocarcinoma. Negative bone scan (with plain films and/or MRI and/or CT scan confirmation, if necessary). Positive PET and Prostascint scans are not considered proof of metastatic disease. Determination of high-risk status: Patients must have either:. Prostate biopsy Gleason sum ≥ 8 (NOTE: The Kattan nomogram probability must be calculated for all patients, including those eligible based on Gleason sum ≥ 8 only.). ECOG performance status: 0-2.

The full record lists 19 inclusion and 0 exclusion criteria.

How the Study Was Run

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

The participants were allocated by chance, so the Leuprolide group and the comparison group should start out alike.

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

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

It started in 2007-05-08 with completion listed for 2018-10-02.

It ran at 226 sites in United States (221) and Canada (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Proportion of Biochemical Progression-Free Survival (bPFS Proportion) at 3 Years (time frame: Up to 3 years).

It also tracked 7 secondary outcomes, for example 5-year bPFS Rate, Unacceptable Toxicity (Grade 3 or Higher Toxicity) and Disease Progression.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide and Goserelin in 788 people.

With 788 participants it is a large trial for this field.

Its status is active not recruiting; 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.