Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial

What Was Tested

The trial (phase 3) is built around Leuprolide.

Determine the role of androgen deprivation therapy in high risk patients receiving 45 Gy of pelvic radiotherapy plus a Pd-103 boost and the impact of the duration of ADT in hormonally-manipulated patients.

It had two arms (groups): no hormones (active comparator) and 9 months of hormone therapy (active comparator).

All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with no hormones.

All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with a 9 month course of hormone therapy.

The registry classes the interventions as drug and radiation.

More on the Plan

However, patients with higher risk features are most often managed with radiotherapeutic approaches to include androgen deprivation therapy.

Following permanent prostate brachytherapy with or without supplemental external beam radiation therapy, favorable long-term biochemical outcomes have been reported for patients with low, intermediate and high risk features with a morbidity profile that compares favorably with competing local modalities (1,2).

Who Took Part

6 actual participants took part.

It was open to men only.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: CT of the abdomen and pelvis and bone scan without evidence of metastases. An enzymatic prostatic acid phosphatase must be obtained prior to randomization. A serum testosterone must be obtained prior to initiation of androgen deprivation therapy. No prior androgen deprivation therapy. Minimum 5 year life expectancy.

The full record lists 8 inclusion and 1 exclusion criteria; among the exclusions: exclusion criteria will be limited to patients who do not meet the above eligibility criteria.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Being open-label, the Leuprolide study did not mask who received what.

It started in 2004-08 with completion listed for 2009-07.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: PSA 3 and 6 months following implantation then every 6 months (time frame: 3 and 6 months following implantation then every 6 months). Serum testosterone levels at 3 and 6 months in hormonally manipulated patients (time frame: 3 and 6 months). Androgen deprivation therapy will not be reinitiated unless the post-treatment PSA exceeds 10 ng/mL or distant metastases are detected (time frame: as needed).

It also tracked 3 secondary outcomes, for example EPIC on 6 and 12 months and then annually and Hormonally manipulated patients will obtain a DEXA scan.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 6 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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