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PSA Levels and Biopsy Samples After Implant Radiation and Hormone Therapy in Patients With Stage I or Stage II Prostate Cancer (SHIP36B)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Jikei University School of Medicine
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00898326
First received: May 9, 2009
Last updated: September 27, 2016
Last verified: September 2016
  Purpose

RATIONALE: Studying samples of blood and tissue from patients with prostate cancer after receiving implant radiation therapy and luteinizing hormone-releasing hormone agonist may help doctors identify biomarkers related to cancer and help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is looking at PSA levels and biopsy samples after undergoing implant radiation therapy and luteinizing hormone-releasing hormone agonist therapy in patients with stage I or stage II prostate cancer.


Condition Intervention
Prostate Cancer
Other: biopsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Biopsy Results at 36 Months After Permanent I-125 Implantation Therapy Plus LHRH-agonist Therapy for Patients With Untreated Intermediate Prostate Cancer.

Resource links provided by NLM:


Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:
  • Comparison of PSA levels and biopsy results at 36 months months [ Time Frame: 36-39 month after PI-125 ] [ Designated as safety issue: No ]
    Compare biobsy results and PSA revels at baseline vs. 36 months after brachytherapy.


Enrollment: 198
Study Start Date: April 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Biopsy 36 month after breacchytherapy
Biopsy 36 month after breacchytherapy on protocol JUSMH-BRI-GU05-01.
Other: biopsy
Conduct prostatic needle biopsy at 36-39 months-after brachy therapy. Basic method is by transectal ultra-sound-guided systematic biopsy,; systematic sextant biopsy which involves samples from both seminal vesicles is adopted as much as possible.

Detailed Description:

OBJECTIVES:

  • To analyze biopsy results at 36 months after permanent iodine I 125 implantation therapy and luteinizing hormone-releasing hormone (LHRH) agonist therapy for patients with untreated intermediate-risk prostate cancer.

OUTLINE: Patients received luteinizing hormone releasing-hormone (LHRH) agonist therapy and permanent iodine I 125 implantation on protocol JUSMH-BRI-GU05-01.

Patients undergo blood sample collection and tissue biopsy for biomarker/laboratory analysis at 36 months after receiving brachytherapy and releasing-hormone agonist therapy. PSA levels and biopsy results are compared.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Previously enrolled on protocol JUSMH-BRI-GU05-01 and 36 month after treatement of brachytherapy.
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed prostate cancer

    • Previously untreated disease prior to participation on protocol JUSMH-BRI-GU05-01
  • Intermediate-risk disease as defined by the following:

    • Clinical stage < T2c
    • Prostate-specific antigen (PSA) ≤ 20 ng/mL
    • Gleason score < 8
  • Previously enrolled on protocol JUSMH-BRI-GU05-01

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy ≥ 3 months
  • WBC ≥ 2,000/μL
  • Hemoglobin ≥ 10.0 g/dL
  • Platelet count ≥ 100,000/μL
  • Serum creatine level ≤ 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: NCT00898326

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

Publications:
Responsible Party: Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT00898326     History of Changes
Other Study ID Numbers: JUSMH-TRIGU0709  CDR0000593698 
Study First Received: May 9, 2009
Last Updated: September 27, 2016
Health Authority: Japan: Translational Research Informatics Center Ethical Committiee

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on December 09, 2016