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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00664456
First received: April 22, 2008
Last updated: September 16, 2013
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: releasing hormone agonist therapy
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Radiation: iodine I 125
Phase 3

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Biochemical progression-free survival (PFS) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 420
Study Start Date: April 2008
Estimated Primary Completion Date: May 2021 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 ≥ 2,000/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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664456

Locations
Japan
Jikei University School of Medicine Hospital
Tokyo, Japan, 125-8506
Sponsors and Collaborators
Jikei University School of Medicine
Investigators
Principal Investigator: Shin Egawa, MD, PhD Jikei University School of Medicine
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00664456     History of Changes
Other Study ID Numbers: CDR0000593653, JUSMH-BRI-GU05-01
Study First Received: April 22, 2008
Last Updated: September 16, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIB prostate cancer
stage IIA prostate cancer
stage I prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014