Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments adjuvant therapy, neoadjuvant therapy, brachytherapy(iodine i 125)
Phase phase 3
Sponsor Translational Research Informatics Center, Kobe, Hyogo, Japan
Collaborator The Jikei University School of Medicine
Start date April 2008
End date May 2021
Trial size 421 participants
Trial identifier NCT00664456, BRIGU05-01, CDR0000593653

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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).
adjuvant therapy
AHT group receives 9 cycle of LHRH-A (goserelin acetate 3.6 mg/4 weeks or leuprorelin acetate 3.75 mg/4 weeks) after Iodine I-125 implantation (TPPB).
neoadjuvant therapy
3 cycle of LHRH-A (goserelin acetate 3.6mg/4 weeks or leuprorelin acetate 3.75mg/4 weeks).
brachytherapy(iodine i 125)
Undergo Iodine I-125 transperineal prostatic brachytherapy (TPPB).
(Active Comparator)
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.
neoadjuvant therapy
3 cycle of LHRH-A (goserelin acetate 3.6mg/4 weeks or leuprorelin acetate 3.75mg/4 weeks).
brachytherapy(iodine i 125)
Undergo Iodine I-125 transperineal prostatic brachytherapy (TPPB).

Primary Outcomes

Measure
Biochemical progression-free survival (bPFS)
time frame: 7 years

Secondary Outcomes

Measure
Overall survival (OS)
time frame: 13.5 years
Clinical progression-free survival
time frame: 7 years
Disease-specific survival
time frame: 7 years
Salvage therapy non-adaptive interval
time frame: 7 years
Quality of life (QOL) evaluation
time frame: Baseline and Month 60 after TPPB
Adverse events (AE)
time frame: AE to androgen-deprivation therapy (ADT) within 24 month, AE to 125I-transperineal prostatic brachytherapy (TPPB) within 36 month of the therapy

Eligibility Criteria

Male participants from 20 years up to 75 years old.

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed prostate cancer - Previously untreated disease - Intermediate-risk disease, as defined by the following: - Clinical stage < T2c - Prostate-specific antigen (PSA) ≤ 20 ng/mL - Gleason score < 8 PATIENT CHARACTERISTICS: - ECOG performance status 0-1 - Life expectancy ≥ 3 months - Leukocyte count ≥ 3,000/uL - Hemoglobin ≥ 10.0 g/dL - Platelet count ≥ 100,000/uL - Serum creatinine ≤ 2.0 mg/dL - ALT and AST ≤ 100 IU/L - No other cancer requiring treatment - No poorly controlled hypertension (i.e., diastolic blood pressure ≥ 120 mm Hg) - No severe psychiatric disorders, including schizophrenia or dementia - No poorly controlled diabetes - Considered appropriate for study participation, as determined by the Principal Investigator or Clinical Investigator PRIOR CONCURRENT THERAPY: - No prior drugs for benign prostatic hyperplasia (other than antiandrogen therapy) - No prior surgery for prostate cancer - No concurrent steroid drugs (except for ointment) - No other concurrent antiandrogen therapy

Additional Information

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.
Principal investigator Shin Egawa, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Translational Research Informatics Center, Kobe, Hyogo, Japan.