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.
Overview
- Phase
- Phase 3
- Intervention
- Adjuvant therapy
- Conditions
- Prostate Cancer
- Sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Enrollment
- 421
- Locations
- 1
- Primary Endpoint
- Biochemical progression-free survival (bPFS)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
OBJECTIVES: * 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
AHT group
Randomized patients undergo 3-month neoadjuvant therapy (NHT)within 14 days and receive 9-month adjuvant therapy (AHT) following after Iodine I-125 implantation (TPPB).
Intervention: Adjuvant therapy
AHT group
Randomized patients undergo 3-month neoadjuvant therapy (NHT)within 14 days and receive 9-month adjuvant therapy (AHT) following after Iodine I-125 implantation (TPPB).
Intervention: Neoadjuvant therapy
AHT group
Randomized patients undergo 3-month neoadjuvant therapy (NHT)within 14 days and receive 9-month adjuvant therapy (AHT) following after Iodine I-125 implantation (TPPB).
Intervention: Brachytherapy（iodine I 125）
Non-AHT group
Rondomized patients undergo 3-month neoadjuvant therapy (NHT) within 14 days and receive Iodine I-125 implantation therapy (TPPB). 40 weeks observation is followed under no further treatment.
Intervention: Neoadjuvant therapy
Non-AHT group
Rondomized patients undergo 3-month neoadjuvant therapy (NHT) within 14 days and receive Iodine I-125 implantation therapy (TPPB). 40 weeks observation is followed under no further treatment.
Intervention: Brachytherapy（iodine I 125）
Outcomes
Primary Outcomes
Biochemical progression-free survival (bPFS)
Time Frame: 7 years
Interval from the 1st day of treatement to the earliest day on which confirmation of increase in prostate specific antigen (PSA) or death any reason.
Secondary Outcomes
- Overall survival (OS)(13.5 years)
- Clinical progression-free survival(7 years)
- Adverse events (AE)(AE to androgen-deprivation therapy (ADT) within 24 month, AE to 125I-transperineal prostatic brachytherapy (TPPB) within 36 month of the therapy)
- Disease-specific survival(7 years)
- Salvage therapy non-adaptive interval(7 years)
- Quality of life (QOL) evaluation(Baseline and Month 60 after TPPB)