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Luteinizing Hormone-Releasing Hormone Agonist Therapy and Iodine I 125 Implant in Treating Patients With Previously Untreated Prostate Cancer (SHIP0804)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Jikei University School of Medicine
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00664456
First received: April 22, 2008
Last updated: September 27, 2016
Last verified: September 2016
  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: Adjuvant therapy
Drug: Neoadjuvant therapy
Radiation: Brachytherapy(iodine I 125)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:
  • Biochemical progression-free survival (bPFS) [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    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:
  • Overall survival (OS) [ Time Frame: 13.5 years ] [ Designated as safety issue: No ]
    Interval from the 1st day of treatment to the earliest day of death any reason.

  • Clinical progression-free survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    Interval from the 1st day of treatment to the ealiest day on which identification of desease progression or death for any reason.

  • Disease-specific survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    Interval from the 1st day of treatment to death caused by prostate cancer

  • Salvage therapy non-adaptive interval [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    Observational term as salvage therapy non-adaptive interval.

  • Quality of life (QOL) evaluation [ Time Frame: Baseline and Month 60 after TPPB ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 421
Study Start Date: April 2008
Estimated Study Completion Date: May 2021
Estimated Primary Completion Date: May 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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).
Drug: 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).
Drug: Neoadjuvant therapy
3 cycle of LHRH-A (goserelin acetate 3.6mg/4 weeks or leuprorelin acetate 3.75mg/4 weeks).
Radiation: Brachytherapy(iodine I 125)
Undergo Iodine I-125 transperineal prostatic brachytherapy (TPPB).
Active Comparator: 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.
Drug: Neoadjuvant therapy
3 cycle of LHRH-A (goserelin acetate 3.6mg/4 weeks or leuprorelin acetate 3.75mg/4 weeks).
Radiation: Brachytherapy(iodine I 125)
Undergo Iodine I-125 transperineal prostatic brachytherapy (TPPB).

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   (Adult, Senior)
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 ≥ 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
  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
The Jikei University School of Medicine
Tokyo, Japan, 125-8506
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
The Jikei University School of Medicine
Investigators
Principal Investigator: Shin Egawa, MD, PhD The Jikei University School of Medicine
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT00664456     History of Changes
Other Study ID Numbers: BRIGU05-01  CDR0000593653 
Study First Received: April 22, 2008
Last Updated: September 27, 2016
Health Authority: Japan: Translational Research Informatics Center Institutional Review Board

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
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
Iodine
Cadexomer iodine
Prolactin Release-Inhibiting Factors
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on December 07, 2016