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

Analysis of Biopsy Results at 36 Months After Permanent I-125 Implantation Therapy Plus LHRH-agonist Therapy for Patients With Untreated Intermediate Prostate Cancer.

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: biopsy

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.

• Study Type: Observational
• Enrollment (Actual): 198

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 125-8506
    • Jikei University School of Medicine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Collaborators: Jikei University School of Medicine
• Investigators: Principal Investigator: Shin Egawa, MD, PhD, Jikei University School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2011
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: May 9, 2009
• First Submitted That Met QC Criteria: May 9, 2009
• First Posted (Estimate): May 12, 2009

Study Record Updates

• Last Update Posted (Actual): June 2, 2017
• Last Update Submitted That Met QC Criteria: June 1, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: JUSMH-TRIGU0709; CDR0000593698 (Registry Identifier: PDQ (Physician Data Query))