NCT00898326

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
1.9 years until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

June 2, 2017

Status Verified

June 1, 2017

Enrollment Period

5.8 years

First QC Date

May 9, 2009

Last Update Submit

June 1, 2017

Conditions

Prostate Cancer

Keywords

stage I prostate cancerstage IIB prostate cancerstage IIA prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Comparison of PSA levels and biopsy results at 36 months months

    Compare biobsy results and PSA revels at baseline vs. 36 months after brachytherapy.

    36-39 month after PI-125

Study Arms (1)

Biopsy 36 month after breacchytherapy

Biopsy 36 month after breacchytherapy on protocol JUSMH-BRI-GU05-01.

Other: biopsy

Interventions

biopsyOTHER

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.

Biopsy 36 month after breacchytherapy

Eligibility Criteria

Age20 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Previously enrolled on protocol JUSMH-BRI-GU05-01 and 36 month after treatement of brachytherapy.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Jikei University School of Medicine Hospital

Tokyo, 125-8506, Japan

Location

Related Publications (1)

  • Miki K, Kiba T, Sasaki H, Kido M, Aoki M, Takahashi H, Miyakoda K, Dokiya T, Yamanaka H, Fukushima M, Egawa S. Transperineal prostate brachytherapy, using I-125 seed with or without adjuvant androgen deprivation, in patients with intermediate-risk prostate cancer: study protocol for a phase III, multicenter, randomized, controlled trial. BMC Cancer. 2010 Oct 21;10:572. doi: 10.1186/1471-2407-10-572.

    PMID: 20964826RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Shin Egawa, MD, PhD

    Jikei University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

April 1, 2011

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

June 2, 2017

Record last verified: 2017-06

Locations

JP(1)