Intensity-Modulated Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Prostate Cancer

What Was Tested

This registered phase 1, phase 2 trial tested Leuprolide and Goserelin.

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells.

The registry classes the interventions as drug and radiation.

More on the Plan

OUTLINE: Patients undergo radioimmunoguided intensity-modulated radiotherapy once daily, 5 days a week for 8½ weeks.

Beginning the last week of radiotherapy, some patients receive leuprolide acetate intramuscularly every 3-4 months or goserelin subcutaneously every 3 months for 6 months, 12 months, or until disease progression.

After completion of study treatment, patients are followed every 3-4 months for 1 year, every 6 months for 4 years and annually thereafter.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to men only aged from 19 years with no upper age limit.

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

Examples of who could join: Stage I-IV disease (T1-4, N0-1, M0). No evidence of distant metastases (M0) on physical examination or bone scan. ECOG performance status 0-2. WBC ≥ 3,000/mcL. Platelet count ≥ 90,000/mm.

The full record lists 10 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was open-label.

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

It started in 2002-03 with completion listed for 2006-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Toxicity. Survival rates. Freedom from biochemical relapse rates.

It also tracked 2 secondary outcomes, for example Obstructive urinary symptoms and Sexual health as assessed by inventory questionnaire.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Leuprolide and Goserelin in 100 people.

The trial is marked completed; 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.