Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in de Novo oligometaStatic Prostate Cancer (TERPS) Trial
Summary
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.
Detailed description
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.
Arms & interventions
- RadiationProstate radiation (XRT)
Both arms will receive prostate radiation. Multiple treatment regimens are allowed per protocol.
- DrugSystemic Therapy
All systemic therapy is provided as best prescribed for patient per their medical oncologist.
- RadiationStereotactic ablative radiation therapy (SABR)
SABR is delivered to those randomized to Arm 2.
Outcome measures
Primary
To 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
Secondary
To determine the number of participants with toxicities related to SABR MDT in patients with de novo oligometastatic disease
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
Time frame: 5 years
Quality of life assessed through EPIC tool utilizing patient scores in each function group following completion of SABR MDT.
Time frame: 5 years
Eligibility criteria
Study locations (10)
UC San Diego Moores Cancer Center
La Jolla, California, 92093
KU Medical Center- Cancer Center
Kansas City, Kansas, 66160
Maryland Proton Treatment Center
Baltimore, Maryland, 21201
UMMC
Baltimore, Maryland, 21201
Upper Chesapeake Health
Bel Air, Maryland, 21014
Central Maryland Radiation Oncology
Columbia, Maryland, 21044
Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
Sidney Kimmel Cancer Center at Jefferson Health
Philadelphia, Pennsylvania, 19107
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Bon Secours Cancer Institute at St. Francis
Midlothian, Virginia, 23114