drugset / Trial / NCT05352178

Metastasis-directed Therapy for Oligorecurrent Prostate Cancer

NCT05352178

Phase 3 Recruiting 873 enrolled Universitaire Ziekenhuizen KU Leuven
RandomizedParallel-groupOpen-labelTreatment

Summary

The aim is to investigate whether the addition of short-term androgen deprivation therapy (ADT) during 1 month or short-term ADT during 6 months together with an androgen receptor targeted therapy (ARTA) to metastasis-directed therapy (MDT) significantly prolongs poly-metastatic free survival (PMFS) and/or metastatic castration-refractory prostate cancer free survival (mCRPC-FS) in patients with oligorecurrent hormone sensitive prostate cancer.

Timeline

Start
2022-04-20
Primary completion
2027-04-25
Completion
2032-04-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Enzalutamide Other / unclassified 160 mg
Subject Gosereline Unknown 3.6 mg Subcutaneous
Subject Gosereline Unknown 10.8 mg Subcutaneous
Subject Leuprolide Other / unclassified 7.5 mg Subcutaneous
Subject Leuprolide Other / unclassified 45 mg Subcutaneous
Subject Triptoreline Unknown 3.75 mg Intramuscular
Subject Triptoreline Unknown 11.5 mg Intramuscular
Subject Triptoreline Unknown 22.5 mg Intramuscular