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

Last updated: July 21, 2023
Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Overall Status: Completed

Phase

3

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Urologic Cancer

Treatment

Neoadjuvant therapy

Brachytherapy(iodine I 125)

Adjuvant therapy

Clinical Study ID

NCT00664456
BRIGU05-01
CDR0000593653
  • Ages 20-75
  • Male

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 421
Treatment Group(s): 3
Primary Treatment: Neoadjuvant therapy
Phase: 3
Study Start date:
April 01, 2008
Estimated Completion Date:
June 30, 2023

Study 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.

Connect with a study center

  • The Jikei University School of Medicine

    Tokyo, 125-8506
    Japan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.