Management of Castration-Resistant Prostate Cancer with Oligometastases

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.

NCT Number	NCT02685397
Lead Sponsor	Sir Mortimer B. Davis - Jewish General Hospital
Conditions	Castration-resistant Prostate Cancer Patients with Oligometastases
Enrollment	102 participants
Start Date	2016-10
Primary Completion	2027-04 (estimated)
Study Completion	2041-08 (estimated)
Updated on ClinicalTrials.gov	2024-12-04