Clinical trial NCT00898326: PSA Levels and Biopsy Samples After Implant Radiation and Hormone Therapy in Patients With Stage I or Stage II Prostate Cancer
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Jikei University School of Medicine
First posted: 2009-05-12
Enrollment: 198
Sex: MALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously enrolled on protocol JUSMH-BRI-GU05-01 and 36 month after treatement of brachytherapy.

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.

Eligibility 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

Primary outcomes:
measure: Comparison of PSA levels and biopsy results at 36 months months
timeFrame: 36-39 month after PI-125
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Jikei University School of Medicine Hospital
Study officials:
affiliation: Jikei University School of Medicine
name: Shin Egawa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.