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

Prostate Cancer Clinical Trial

— SHIP36B  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898326
• Other study ID #: JUSMH-TRIGU0709
• Secondary ID: CDR0000593698
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: June 1, 2017
• Start date: April 1, 2011
• Est. completion date: December 31, 2016

Study information

• Verified date: June 2017
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Japan	Jikei University School of Medicine Hospital	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan	Jikei University School of Medicine

Country where clinical trial is conducted

Japan, 

References & 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 prostat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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