Management of Castration-Resistant Prostate Cancer with Oligometastases

What Was Tested

This registered phase 2, phase 3 trial tested Leuprolide and Goserelin.

Only CRPC patients with an oligometastatic recurrence will be eligible to take part in this trial.

All participating patients will receive either the standard of care (i.e.

It had two arms (groups): LHRH agonist + Enzalutamide (active comparator) and LHRH agonist + Enzalutamide + SBRT (experimental).

The registry classes the interventions as drug and radiation.

More on the Plan

Lifelong androgen deprivation therapy (ADT) with LHRH agonists can help delay cancer progression in metastatic PCa patients.

However, patients eventually become castration-resistant (disease progression despite ADT) and develop progressive metastatic disease.

This in turn impacts the patient's quality of life and survival.

Recently, a new generation of hormonal therapy (such as Enzalutamide) has become available to these castration-resistant prostate cancer (CRPC) patients.

Who Took Part

Enrollment: 102 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: Age 18 or older and willing and able to provide informed consent;. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;. Ongoing androgen deprivation therapy with a Gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy (i.e., surgical or medical castration);. No prior cytotoxic chemotherapy for prostate cancer;. The use of condoms (barrier method).

The full record lists 21 inclusion and 35 exclusion criteria; among the exclusions: severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment;; known or suspected brain metastasis or active leptomeningeal disease;; history of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer;.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

The Leuprolide group and the comparison group ran side by side rather than switching.

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.

It started in 2016-10 with completion listed for 2027-04.

It ran at 11 sites in Canada (11).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Radiographic Progression-free Survival (time frame: 5 years).

It also tracked 11 secondary outcomes, for example Quality of Life, Quality of Life - Fatigue, Quality of Life - Pain, Toxicity, Prostate Cancer Specific Survival and Time to Skeletal-related Event.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Leuprolide and Goserelin in 102 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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