A Study of Definitive Therapy to Treat Prostate Cancer

What Was Tested

The trial (phase 2) is built around Leuprolide.

The men will receive a total of 1 year of androgen deprivation.

Androgen blockade will be the same throughout the course of treatment.

It had 1 arm (groups): chemohormonal and definitive therapy (experimental).

(1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of neoadjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.

The registry classes the interventions as drug, procedure and radiation.

More on the Plan

Neoadjuvant treatment (month 1 through \~6): All patients will be treated with up to 6 months of androgen deprivation, plus up to 6 cycles of docetaxel chemotherapy.

Surgery and Radiation (month 7 though \~11): After completion of neoadjuvant therapy, the men will be treated with definitive local therapy with radical prostatectomy (RP) +/- adjuvant radiation therapy (RT).

After definitive local therapy, patients will be treated with consolidative stereotactic body radiation therapy (SBRT) to the metastatic sites.

Follow up: Patients will continue on androgen deprivation for a total of 1 year.

Who Took Part

26 actual participants took part.

It was open to men only aged from 18 years up to 80 years.

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

Examples of who could join: Willing and able to provide written informed consent. Age ≥ 18 years. Eastern cooperative group (ECOG) performance status ≤2. Documented histologically confirmed adenocarcinoma of the prostate. Able to swallow the study drugs whole as tablets.

The full record lists 7 inclusion and 16 exclusion criteria; among the exclusions: prior therapy to a metastatic site; hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix); cytochrome (cyp) -17 inhibitors (e.g. ketoconazole).

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 2016-06 with completion listed for 2022-04.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example Safety of the Multimodality Therapy as Assessed by Number of Participants With Neutropenia and Surgical or Radiation Toxicities and Time to Prostate-specific Antigen Recurrence.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide in 26 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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