Management of Castration-Resistant Prostate Cancer With Oligometastases
Status:
Recruiting
Trial end date:
2041-08-01
Target enrollment:
Participant gender:
Summary
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.