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


N/A
20 Years
75 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.

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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Comparison of PSA levels and biopsy results at 36 months

Safety Issue:

No

Principal Investigator

Shin Egawa, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jikei University School of Medicine

Authority:

Unspecified

Study ID:

CDR0000593698

NCT ID:

NCT00898326

Start Date:

April 2008

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • Prostatic Neoplasms

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