NCT00003312

Brachytherapy in Treating Patients With Prostate Cancer

Official Title:

Phase II Trial of Transrectal Ultrasound Guided Permanent Radioactive Implantation of the Prostate for Definitive Management of Localized Adenocarcinoma of the Prostate

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy through seeds implanted into the prostate may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of brachytherapy in treating patients with stage I or stage II prostate cancer.

Eligibility

DISEASE CHARACTERISTICS: Histologically proven locally confined adenocarcinoma of the prostate Stage I or II (T1b-c or T2a-b, NX, M0) PSA no greater than 10 ng/mL Prostate volume by transurethral ultrasound no greater than 45/mm3 at least 1 week, but no more than 4 weeks, prior to implant Gleason score no greater than 6 American Urological Association voiding symptom score no greater than 12 No evidence of distant metastases No lymph node involvement

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No prior or concurrent malignancy within 5 years except basal or squamous cell skin cancer No major medical or psychiatric illness

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No prior hormonal therapy, including finasteride Radiotherapy: No prior pelvic radiotherapy Surgery: No prior radical surgery for prostate cancer (e.g., transurethral prostatectomy) No hip prosthesis

Disease(s) and\or Condition(s)

Prostate Cancer

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: RADIATION
    • Name: iodine I 125
    • Description:
    • Arm Group Labels:
Sponsor
  • Radiation Therapy Oncology Group