Potential surrogate endpoints for prostate cancer survival: analysis of a phase III randomized trial

What Was Tested

Researchers studied Goserelin in this randomized controlled trial publication.

The identification of surrogate endpoints for prostate cancer-specific survival may shorten the length of clinical trials for prostate cancer.

The researchers evaluated distant metastasis and general clinical treatment failure as potential surrogates for prostate cancer-specific survival by use of data from the Radiation Therapy and Oncology Group 92-02 randomized trial.

Who Took Part

By PubMed's age tags, the people studied were middle-aged adults and older adults, men only.

Patients (n = 1554 randomly assigned and 1521 evaluable for this analysis) with locally advanced prostate cancer had been treated with 4 months of neoadjuvant and concurrent androgen deprivation therapy with external beam radiation therapy and then randomly assigned to no additional therapy (control arm) or 24 additional months of androgen deprivation therapy (experimental arm).

Data from landmark analyses at 3 and 5 years for general clinical treatment failure (defined as documented local disease progression, regional or distant metastasis, initiation of androgen deprivation therapy, or a prostate-specific antigen level of 25 ng/mL or higher after radiation therapy) and/or distant metastasis were tested as surrogate endpoints for prostate cancer-specific survival at 10 years by use of Prentice's four criteria.

How the Study Was Run

In design terms this was a randomized 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.

All statistical tests were two-sided.

What Was Measured

The identification of surrogate endpoints for prostate cancer-specific survival may shorten the length of clinical trials for prostate cancer.

The researchers evaluated distant metastasis and general clinical treatment failure as potential surrogates for prostate cancer-specific survival by use of data from the Radiation Therapy and Oncology Group 92-02 randomized trial.

PubMed files the paper under topics including Androgen Antagonists, Antineoplastic Agents, Hormonal, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Tumor, Chemotherapy, Adjuvant, Disease-Free Survival and Endpoint Determination.

What This Means in Plain Language

The paper is a randomized study of Goserelin.

Its findings take up roughly 6 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2009 (Journal of the National Cancer Institute), a journal based in United States.

More context: the Goserelin compound page.