This research is being done to see if we can improve the outcome of prostate cancer patients who present with metastatic lesions at initial diagnosis.
This study will compare the effects, good and/or bad, of using the standard of care treatment (systemic therapy + primary prostate radiation) compared to standard of care treatment plus stereotactic ablative radiation therapy (SABR) to metastatic lesions for prostate patients. The researchers are also trying to learn if the addition of SABR will affect recurrence rates. Presence of circulating tumor cells, gut bacteria, and quality of life will be assessed for both groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
Both arms will receive prostate radiation. Multiple treatment regimens are allowed per protocol.
All systemic therapy is provided as best prescribed for patient per their medical oncologist.
SABR is delivered to those randomized to Arm 2.
UC San Diego Moores Cancer Center
La Jolla, California, United States
RECRUITINGMaryland Proton Treatment Center
Baltimore, Maryland, United States
RECRUITINGTo determine the 2-year failure-free survival (FFS) of men who have oligometastatic prostate cancer with BST+XRT versus BST+XRT+SABR MDT.
Cross-over to the SABR MDT is allowed following failure.
Time frame: 2 years
To determine the number of participants with toxicities related to SABR MDT in patients with de novo oligometastatic disease
Adverse events will be assessed at baseline, on treatment visit, and follow-up visit.
Time frame: 5 years
To determine local control at 12-months after SABR MDT in patients with de novo oligometastatic disease.
Time frame: 1 year
To assess time to progression
Progression will be assessed for time to locoregional progression, time to distant progression, time to new metastasis, radiographic progression-free survival and duration of response after randomization to best systemic therapy (BST) and primary prostate radiation (XRT) versus BST, XRT and stereotactic ablative radiation therapy (SABR) metastasis-directed therapy (MDT).
Time frame: 5 years
Quality of life assessed through EPIC tool utilizing patient scores in each function group following completion of SABR MDT.
EPIC quality of life tool will be used to assess quality of life following treatment. This survey will be completed at baseline and during follow-up visits. Averages will be taken for each section in the survey (Urinary Function, Bowel Function, Sexual Function, and Hormonal function).
Time frame: 5 years
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UMMC
Baltimore, Maryland, United States
Upper Chesapeake Health
Bel Air, Maryland, United States
NOT_YET_RECRUITINGCentral Maryland Radiation Oncology
Columbia, Maryland, United States
RECRUITINGBaltimore Washington Medical Center
Glen Burnie, Maryland, United States
RECRUITINGSidney Kimmel Cancer Center at Jefferson Health
Philadelphia, Pennsylvania, United States
RECRUITINGUPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
RECRUITINGBon Secours Cancer Institute at St. Francis
Midlothian, Virginia, United States
RECRUITING