ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer

What Was Tested

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

For this study, unfavorable intermediate risk prostate cancer patients will select whether they are to be treated with the standard of care (SOC) 6 months of Androgen Deprivation Therapy (ADT) in conjunction with stereotactic body radiation therapy/radiosurgery (SBRT) directed to the prostate versus SBRT alone.

The patient population will include those with National Comprehensive Cancer Network (NCCN)-defined unfavorable intermediate risk disease.

All patients will be followed every 6 months for up to 5 years from the first patient treated and will undergo a routine 24-30 months post-SBRT prostate biopsy to assess for local tumor control.

It had two arms (groups): ADT with SBRT (experimental) and SBRT Alone (active comparator).

The ADT patients will be treated with monthly Degarelix, or Leuprolide injections or daily Relugolix pills. After three months have elapsed, these patients as per routine will undergo SBRT. SBRT comprises stereotactic, ultra-fractionated radiotherapy every other day for five total treatments.

Participants treated with SBRT alone (standard of care) will be administered stereotactic, ultra-fractionated radiotherapy every other day for five total treatments.

The registry classes the interventions as drug and radiation.

Who Took Part

392 planned participants were the target.

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.

The full record lists 11 inclusion and 5 exclusion criteria; among the exclusions: CT or MRI or Positron Emission Tomography (PET) scan evidence of metastatic disease to the bone; patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on mri or ct or pet scan; patients with crohn's disease or ulcerative colitis.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2024-04-16 with completion listed for 2030-04-16.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Disease-Free Survival (time frame: Up to Year 5).

It also tracked 7 secondary outcomes, for example Incidence of Biochemical Failure, Incidence of Distant Metastases, Overall Survival, Number of Positive Post-Treatment Biopsies, Change in Expanded Prostate Cancer Index Composite (EPIC) Questionnaire Score (EPIC-26) and Change in International Prostatism Symptom Score (IPSS).

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Leuprolide and Degarelix in 392 people.

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

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