Stereotactic Boost and Long-Term Androgen Deprivation for Adenocarcinoma of the Prostate

What Was Tested

This registered phase 1 trial tested Leuprolide.

Their primary objective is to assess the feasibility and safety of a treatment strategy incorporating whole pelvic IMRT followed by an SBRT boost to the prostate with neoadjuvant, concurrent, and adjuvant androgen deprivation for a total of 28 months for men with unfavorable intermediate or high risk localized prostate cancer.

It had 1 arm (groups): Single (experimental).

Neoadjuvant Androgen Blockade (Casodex) Followed by: Intensity Modulated Radiotherapy (IMRT)2 with Concurrent Androgen Blockade (Casodex and Leuprolide) to Whole Pelvis, Prostate, and Seminal VesiclesFollowed by: Stereotactic Radiosurgical Boost3 to the Prostate with Implanted Electromagnetic Transponder Beacon Intrafraction Guidance Followed by: Adjuvant Androgen Blockade (Casodex).

The registry classes the interventions as drug and radiation.

More on the Plan

The secondary objective is to assess biochemical control at 24 months following the experimental treatment strategy by the "Phoenix definition".

Another secondary objective is to assess toxicity of the experimental treatment approach as scored by the Common Terminology Criteria for Adverse Events The third secondary objective is to assess prostate organ motion during hypofractionated radiotherapy.

To assess motion of the prostate during the protracted delivery of hypofractionated radiotherapy as assessed by implanted electromagnetic transponder beacons.

Who Took Part

The registry lists 17 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: Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence. History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration. Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MRI), (but not by nodal sampling, or dissection) within 90 days prior to registration. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 2.0 cm. No evidence of bone metastases (M0) on bone scan within 90 days prior to registration.

The full record lists 11 inclusion and 13 exclusion criteria; among the exclusions: prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 2 years; previous radical surgery (prostatectomy) or cryosurgery for prostate cancer; previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2013-06-06 with completion listed for 2020-12-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Tumor Assessment (time frame: 24 months).

It also tracked 1 secondary outcome, for example Zubrod Performance Scale.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Leuprolide in 17 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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