Clinical Trial Comparing 3-D RT vs. IMRT in Post- Prostatectomy Prostate Cancer Patients

What Was Tested

In this phase 2 trial, researchers set out to test Leuprolide and Goserelin.

Compare the incidence of acute rectal, bladder and other acute toxicities between 3-D Conformal Radiation Therapy (RT/CRT) and Intensity Modulated Radiation Therapy (IMRT) in Post-Prostatectomy Prostate Cancer Patients treated with post-operative radiation therapy.

It had two arms (groups): 3-D conformal radiation therapy (experimental) and Intensity modulated radiation therapy (active comparator).

The registry classes the interventions as drug and radiation.

More on the Plan

In 2015, the American Cancer Society estimates that almost 220,800 men are expected to be diagnosed with prostate cancer, and about 27,540 men are expected to die of this disease.

Curative treatment of prostate cancer consists of either surgery (i.e., radical prostatectomy) or radiation therapy (RT).

Approximately one-third of men who undergo a prostatectomy will require post-operative adjuvant or salvage RT.

During the last 2 decades, the techniques used to deliver RT have evolved from 2-D RT in the 1980's and early 1990's, to 3-D conformal RT (3-D CRT) in the late 1990's, to intensity modulated radiation therapy (IMRT) within the last decade.

Who 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 documented adenocarcinoma of the prostate. Pathologic T2N0 (with no clinical evidence of metastases) and Gleason Score ≥ 8. Pathologic T3aN0 (with no clinical evidence of metastases) with Extra-Capsular Extension and Gleason Score ≥ 8. Pathologic T3bN0 (with no clinical evidence of metastases) with any Gleason Score. Pathologic T3bN0 disease (with no clinical evidence of metastases),.

The full record lists 27 inclusion and 4 exclusion criteria; among the exclusions: patients who have received prior pelvic irradiation are not eligible; patients with active infections or known infection with hiv. testing for hiv status will not be required; psychological, familiar, sociological or geographical conditions which would not permit compliance with the study protocol.

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 2015-12 with completion listed for 2016-02.

It ran at 1 site in United States.

What Was Measured

Primary outcome: Acute rectal, bladder and other toxicity rates - For participants 1 through 10 in each treatment arm. Acute rectal, bladder and other toxicity rates - For all 100 study participants. Quality of Life measure and comparison - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ C-30).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide and Goserelin in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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