Effects of IAS in Men With Localized Biochemical Relapsed Prostate Cancer

What Was Tested

This registered phase 2 trial tested Leuprolide.

This study was a prospective analysis in men with localized prostate cancer who had rising Prostate Specific Antigen (PSA) levels after definitive treatment with surgery or radiation.

Patients received Intermittent Androgen Suppression (IAS) in 9 month cycles until they became metastatic, became castrate resistant, or withdrew from the study.

Subjects were monitored for time to development of Castration Resistant Prostate Cancer (CRPC) and overall survival.

It had 1 arm (groups): Intermittent Androgen Suppression (IAS) (experimental).

The registry classes the interventions as drug.

More on the Plan

The standard first line treatment for men with early stage newly diagnosed localized prostate cancer is a surgical removal of the prostate, localized external beam radiation, brachytherapy, or a combination of surgery and radiation.

However despite an initial response to localized treatment, some men will go on to later develop a rise in PSA levels, an indicator of Biochemical Relapsed Prostate Cancer (BRPC).

A low value for the PSA is more desirable as it may indicate no tumor growth.

ADT may be administered as a continuous treatment (Continuous Androgen Suppression, or CAS) or as intermittent treatment (Intermittent Androgen Suppression, or IAS).

Who Took Part

Enrollment: 102 actual participants took part.

It was open to men only aged from 21 years with no upper age limit.

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

Examples of who could join: Biochemical relapse (rising PSA) after initial treatment (radiation therapy, brachytherapy, or radical prostatectomy) for histologically or cytologically confirmed adenocarcinoma of the prostate. Clinical stage A2, B, C, D1. Age: older than 21 years old. Performance status of 0 or 1. Pretreatment serum testosterone, normal range (or no clinical evidence of testosterone deficiency).

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: any systemic chemotherapy or curative radiotherapy within 6 months; hepatic dysfunction:; aspartate transaminase (ast; sgot) greater than 3 times the upper limit of normal range.

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 1997-01-08 with completion listed for 2012-09-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time to Androgen Independence of Serum Prostate-Specific Antigen (PSA). Effect of IAS on Overall Survival.

It also tracked 13 secondary outcomes, for example Change in Standardized Bone Mineral Density (BMD) of the Spine During IAS, Change in Standardized Bone Mineral Density (BMD) of the Left Hip During IAS, Development of Osteopenia (Bone Loss) During IAS, Testosterone Levels During IAS, Estradiol Levels During First Cycle of IAS and Score on Spatial Ability Test (Block Design) During First Cycle of IAS.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide in 102 people.

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

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