A Phase III, Multicenter, Randomized, Controlled Study of Neoadjuvant LHRH-agonist Therapy and Permanent I-125 Implantation With vs. Without Adjuvant LHRH-agonist Therapy in Patients With Untreated Intermediate-risk Prostate Cancer.
- To evaluate the biochemical progression-free survival (PFS), overall survival, clinical
PFS, and disease-free survival of patients with previously untreated intermediate-risk
prostate cancer treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)
agonist therapy and permanent iodine I 125 implantation with vs without adjuvant LHRH
- To determine the non-adaptive interval to salvage therapy in patients treated with
- To determine the safety of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive neoadjuvant luteinizing hormone-releasing hormone (LHRH)
agonist therapy for up to 3 months and undergo permanent iodine I 125 implantation.
Patients then receive adjuvant LHRH agonist therapy for up to 9 months.
- Arm II: Patients receive neoadjuvant LHRH agonist therapy and undergo permanent iodine
I 125 implantation as in arm I.
Allocation: Randomized, Primary Purpose: Treatment
Biochemical progression-free survival (PFS)
Shin Egawa, MD, PhD
Jikei University School of Medicine
United States: Federal Government