About this trial
This phase II trial studies the effects of stereotactic body radiation therapy (SBRT) and the timing of treatment with androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread from where it first started to other places in the body (metastatic), and that has come back after a period of improvement (recurrent). It also studies the effects of salvage radiation therapy (sXRT) on prostate cancer and to see if radiation to the pelvis helps prevent prostate cancer from spreading elsewhere. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Androgen can cause the growth of prostate cells. ADT lowers the amount of androgen made by the body. This may help stop the growth of tumor cells that need androgen to grow. Androgen receptor pathway inhibitors work by blocking the effects of androgen to stop the growth and spread of tumor cells. sXRT is a targeted radiation treatment for the prostate, typically given when cancer possibly returns after surgery or radiation. Its goal is to destroy any tumor cells in the area. Giving SBRT alone with watchful waiting may be as effective in treating prostate cancer as giving SBRT together with ARPI and ADT and sXRT may be effective in treating prostate cancer and preventing it from spreading elsewhere.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Clinical confirmation of metachronous (metastatic) recurrent hormone-sensitive prostate cancer
Five (5) or fewer metastases with at least one metastasis beyond the pelvis on advanced molecular and/or conventional imaging
Serum testosterone > 100ng/dL
Disqualifiers
Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown
Pregnant persons
Nursing persons
Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception
Trial design
Treatments tested in this trial
- Abiraterone
- Apalutamide
- Biospecimen Collection
- Bone Scan
- Computed Tomography
- Darolutamide
- Degarelix
- Enzalutamide
- Goserelin
- Histrelin
- Leuprolide
- Magnetic Resonance Imaging
- Patient Observation
- Positron Emission Tomography
- Prednisone
- Questionnaire Administration
- Relugolix
- Stereotactic Body Radiation Therapy
- Triptorelin
- Radiation Therapy
- Image-Guided Therapy
Treatment groups
Sponsors and collaborators
Mayo Clinic
Lead sponsor
National Cancer Institute (NCI)
Collaborator