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

NCT ID: NCT00898326

Last Updated: 2017-06-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 198 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-01
• Study Completion Date: 2016-12-31

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.

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Biopsy 36 month after breacchytherapy

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

biopsy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Jikei University School of Medicine

OTHER

Sponsor Role: collaborator

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shin Egawa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jikei University School of Medicine

Locations

Jikei University School of Medicine Hospital

Tokyo, , Japan

Countries

Japan

References

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.

Reference Type: RESULT

PMID: 20964826 (View on PubMed)

Other Identifiers

CDR0000593698

Identifier Type: REGISTRY

Identifier Source: secondary_id

JUSMH-TRIGU0709

Identifier Type: -

Identifier Source: org_study_id