Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer

What Was Tested

This registered phase 3 trial tested Degarelix.

It had two arms (groups): Degarelix in conjunction with stereotactic body radiosurgery (experimental) and stereotactic body radiosurgery (SBRT) (experimental).

Degarelix monthly for 6 months SBRT 8 Gy x 5.

SBRT 8 Gy x 5.

The registry classes the interventions as drug and radiation.

Who Took Part

Enrollment: 56 actual participants 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: Gleason 7 disease. PSA 10-20 ng/ml. Clinical T2b-T2c disease Note: Patients who only have radiographic evidence of T3 disease (i.e. extracapsular extension, or seminal vesical invasion radiographically) will not be excluded. Serum testosterone ≥ 240 ng/dL determined within 2 months prior to enrollment. At least 4 weeks must have elapsed from major surgery.

The full record lists 15 inclusion and 5 exclusion criteria; among the exclusions: CT or MRI 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; patients with crohn's disease or ulcerative colitis.

How the Study Was Run

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

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

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

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

It started in 2017-03-28 with completion listed for 2023-08-16.

It ran at 10 sites in United States (10).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Patients With a Positive Biopsy (time frame: 2 years).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Degarelix in 56 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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