Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer

What Was Tested

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

Although surgery can be curative in patients evidencing pathological high-risk disease (extracapsular extension, seminal vesicle involvement, positive surgical margins), a large proportion will develop biochemical failure within years from the surgical procedure.

It had 1 arm (groups): Post-op IMRT & hormonal therapy (other).

The protocol is designed to recruit patients who have undergone prostatectomy and high risk features of the disease were found post-operatively or for patients that, after prostatectomy, a PSA rise has been documented will be enrolled in the Phase II trial. Patients will receive Eligard injection 8-12 weeks before starting radiation. The second injection is given 12 weeks after the first one concomitant with radiation therapy.

The registry classes the interventions as drug.

More on the Plan

There are several institutional retrospective reports on the use of RT as salvage therapy but no randomized trial has ever been completed.

The best evidence available, however, supports early salvage RT as the best strategy to be used to maximize results.

This Phase 2 trial will study the potential role of hypofractionated in the post-operative setting in patients with high-risk features with the primary objective of assessing toxicity from this approach.

The use of androgen deprivation therapy in combination with RT in the primary treatment for patients with intermediate or high-risk prostate cancer is well established.

Who Took Part

Enrollment: 77 planned participants were the target.

It was open to men only aged from 18 years with no upper age limit.

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

Examples of who could join: Negative bone metastases proven by bone scan. The use of proton emission tomography (PET) fluoride is allowed. History and physical examination (including digital rectal exam) within 90 days prior of registration. AST or ALT \<2 x the upper limit of normal. PSA and testosterone levels within one month of registration Age ≥ 18. Zubrod Performance Status 0-1.

The full record lists 9 inclusion and 5 exclusion criteria; among the exclusions: previous exposure to androgen deprivation; chemotherapy before or after prostatectomy; prior pelvic radiotherapy.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2019-09-03 with completion listed for 2026-12-15.

It ran at 2 sites in Canada (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Acute Patient Reported Morbidity in genito-urinary and gastrointestinal toxicity (time frame: Up to 90 days after the end of radiation treatment).

It also tracked 2 secondary outcomes, for example Acute Physician-Reported Morbidity in genito-urinary and gastrointestinal toxicity and Late Patient-Reported Morbidity in genito-urinary and gastrointestinal toxicity.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide in 77 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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