The Role of Stereotactic Body Radiation Therapy in the Management of Castration-Resistant Prostate Cancer With Oligometastases: An Adaptive Phase II/III Randomized Trial.
This adaptive phase II/III randomized trial is designed to demonstrate that eradication of
oligometastases by SBRT is a promising and emerging way to delay disease progression and
postpone second line systemic therapies in castration-resistant prostate cancer (CRPC)
patients. Only CRPC patients with an oligometastatic recurrence will be eligible to take
part in this trial. All participating patients will receive either the standard of care
(i.e. LHRH agonist in combination with the new generation of hormonal therapy
[Enzalutamide]) or the experimental treatment (i.e. LHRH agonist in combination with the new
generation of HT [Enzalutamide] plus the additional SBRT treatment). The patients will
undergo different evaluations before treatment, such as imaging to confirm oligometastatic
recurrence and blood tests. Patients will be stratified according to the location of
metastasis (visceral [with or without bone metastases] vs. bone metastases alone) and PSA
doubling time (≤ 3 vs. > 3 months). As per the standard of care, patients will have PSA
testing performed every 6-12 weeks and re-imaging at 6, 9, 12, 18 and 24 months or at PSA
progression, whichever occurs first.
View this trial on ClinicalTrials.gov
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