Luteinizing Hormone-Releasing Hormone Agonist Therapy and Iodine I 125 Implant in Treating Patients With Previously Untreated Prostate Cancer
RATIONALE: Androgens can cause the growth of prostate cancer cells. Luteinizing hormone-releasing hormone agonists may lessen the amount of androgens made by the body. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving luteinizing hormone-releasing hormone agonist together with an iodine I 125 implant may be an effective treatment for patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying how well giving luteinizing hormone-releasing hormone agonist therapy together with an iodine I 125 implant works with or without additional luteinizing hormone-releasing hormone agonist therapy in treating patients with previously untreated prostate cancer.
Drug: releasing hormone agonist therapy
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Radiation: iodine I 125
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||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.|
- Biochemical progression-free survival (PFS) [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Clinical PFS [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
- Non-adaptive interval to salvage therapy [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Estimated Primary Completion Date:||May 2021 (Final data collection date for primary outcome measure)|
- 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 agonist therapy.
- To determine the non-adaptive interval to salvage therapy in patients treated with these regimens.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00664456
|Jikei University School of Medicine Hospital|
|Tokyo, Japan, 125-8506|
|Principal Investigator:||Shin Egawa, MD, PhD||Jikei University School of Medicine|