Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate Cancer

What Was Tested

This registered phase 2 trial tested Leuprolide and Goserelin.

This phase 2 trial studies radium Ra 223 dichloride, hormone therapy and stereotactic body radiation in treating patients with prostate cancer that has spread to other places in the body.

Radium Ra 223 dichloride contains a radioactive substance that collects in the bone and gives off radiation that may kill cancer cells.

Hormone therapy using leuprolide acetate or goserelin acetate may fight prostate cancer by lowering the amount of testosterone the body makes.

It had 1 arm (groups): Treatment (hormone therapy, SBRT, radium Ra 223 dichloride) (experimental).

Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity.

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

More on the Plan

To assess the safety of adding radium Ra 223 dichloride to SBRT and ADT in patients with oligometastatic castration sensitive prostate cancer.

To assess the prostate-specific antigen (PSA) and overall response rate (ORR) after 6 cycles of radium Ra 223 dichloride (cycle 8 day 1).

To assess overall survival, complete response rate, duration of response, and duration of overall complete response and duration of stable disease in patients with oligometastatic castration sensitive prostate cancer who initiated the protocol regimen of ADT with SBRT and radium Ra 223 dichloride.

To perform exploratory analysis of primary or metastatic tumor mutation patterns in this study population at baseline.

Who Took Part

25 actual participants took part.

It was open to people of any sex 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: Documented informed consent of participant and/or legally authorized representative. Agreement to provide archival primary or metastatic tumor tissue if available. Eastern Cooperative Oncology Group (ECOG) =\< 2. Life expectancy \> 12 months. Histologic diagnosis of prostate adenocarcinoma.

The full record lists 25 inclusion and 13 exclusion criteria; among the exclusions: prior radium ra 223 dichloride; prior or concomitant chemotherapy for metastatic or recurrent disease with the following exceptions:; prior chemotherapy for local primary disease is permitted.

How the Study Was Run

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

Being open-label, the Leuprolide study did not mask who received what.

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

It started in 2018-08-29 with completion listed for 2024-03-21.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time to Treatment Failure (time frame: Assessed up to 5 years). Objective Response Rate (time frame: Up to 5 years).

It also tracked 8 secondary outcomes, for example Progression-free Survival, Overall Survival, Complete Response (CR) Rate Defined as the Proportion of Patients Achieving CR, Duration of Response, Duration of Overall Complete Response and Bone Specific Progression-free Survival.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide and Goserelin in 25 people.

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

Its status is active not recruiting; results are posted on the registry, and this page does not restate them.

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