Luteinizing Hormone-Releasing Hormone Agonist Therapy and Iodine I 125 Implant in Treating Patients With Previously Untreated Prostate Cancer

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Adjuvant therapy; Drug: Neoadjuvant therapy; Radiation: Brachytherapy（iodine I 125）

• Registration Number: NCT00664456
• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-22
• Study First Submitted QC: 2008-04-22
• Study First Posted: 2008-04-23
• Primary Completion: 2022-04-24
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 421

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AHT group	Adjuvant therapy	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).
Non-AHT group	Neoadjuvant therapy	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.
AHT group	Brachytherapy（iodine I 125）	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).
AHT group	Neoadjuvant therapy	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).
Non-AHT group	Brachytherapy（iodine I 125）	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.

Primary Outcome Measures

Name	Time	Method
Biochemical progression-free survival (bPFS)	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 Outcome Measures

Name	Time	Method
Salvage therapy non-adaptive interval	7 years	Observational term as salvage therapy non-adaptive interval.
Overall survival (OS)	13.5 years	Interval from the 1st day of treatment to the earliest day of death any reason.
Clinical progression-free survival	7 years	Interval from the 1st day of treatment to the ealiest day on which identification of desease progression or death for any reason.
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	The incident propotion of adverse event grade above 3 by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0) will be compared.
Disease-specific survival	7 years	Interval from the 1st day of treatment to death caused by prostate cancer
Quality of life (QOL) evaluation	Baseline and Month 60 after TPPB	QOL assesed by the Japanese version of the SF-8 (the MOS 8 item Short-Form Health Survey), the Japanese version of the Expanded Prostate Cancer Index Composite (EPIC), and the International Prostate Sympton Score (IPSS).

Trial Locations

Locations (1)

The Jikei University School of Medicine; 🇯🇵 Tokyo, Japan