This study is looking to recruit patients with prostate cancer (PC) spread to the bone to trial internal and external radiotherapy. The main outcome that will be measured is the length of time until patients need androgen deprivation therapy (ADT). This trial will be carried out in Utah, the United States.
The details
PC is one of the most common forms of cancer found in men. Standard treatment for PC is the surgical removal of tumors, chemotherapy, ADT, and radiotherapy. ADT involves hormonal therapy that blocks male sex hormones (such as testosterone) that fuel the growth of PC.
There are multiple ways to deliver radiation. One form is external beam radiotherapy. This delivers radiation from outside the body. Radium-223 (Xofigo) is a form of internal radiotherapy. It is similar to calcium and targets the bones. Cancer cells in the bone take up radium-223 which delivers radiation to them.
This trial is looking at the use of external beam radiotherapy combined with radium-223 in patients who have prostate cancer that has spread to the bone and have not been treated with ADT before. The main outcome will be the length of time until patients require ADT.
Who are they looking for?
This trial is looking to recruit 20 patients with PC spread to the bone. Patients must have testosterone levels equal to or larger than 100ng/dL and must have 5 or fewer bone tumors. Participants must also have adequate red blood cell and white blood cell counts, adequate liver and kidney function. Patients who have a partner of childbearing age must agree to use strong birth control during the study and up to 6 months after the study.
Patients will be excluded from this trial if they have had ADT treatment in the last 6 months, another cancer, heart failure, or significant lung and heart disease.
How will it work
There will be only one group in this trial. All patients will be treated with radium-223 and external radiotherapy. Patients will be treated for a total of 6 cycles of radium-223.
The main outcomes measured will be the length of time patients need ADT, as well as survival and quality of life. Participants will be followed up for up to 2 years.
