Brachytherapy in Treating Patients With Prostate Cancer - Full Text View

Sponsors and Collaborators:	Radiation Therapy Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003312

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: iodine I 125	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Iodine Cadexomer iodine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase II Trial of Transrectal Ultrasound Guided Permanent Radioactive Implantation of the Prostate for Definitive Management of Localized Adenocarcinoma of the Prostate

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	95
Study Start Date:	September 1998

Detailed Description:

OBJECTIVES: I. Evaluate the effectiveness of transrectal ultrasound guided permanent radioactive implantation of the prostate in patients with confined adenocarcinoma of the prostate. II. Assess the overall survival, disease specific survival, clinical relapse (local or distant), PSA levels, and genitourinary and gastrointestinal morbidity in these implant patients. III. Assess the quality of life of these patients.

OUTLINE: This is a multicenter study. Patients receive transrectal ultrasound guided radioactive I-125 seeds implanted into the prostate. At least one week prior to implant, patients undergo transurethral ultrasound study to determine the volume of prostate. Following implantation, seeds that have extruded into the bladder or lodged in the urethral wall are retrieved, and extra seeds may be implanted into identified "cold spots" for uniform seed distribution. Prostate rebiopsy is required before starting hormonal therapy for local progression or biochemical failure without clear focus of progression. Quality of life is assessed every 3 months for 1 year, then every 6 months for 1 year, and then annually for 3 years. Patients are followed every 3 months for 1 year, then every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 95 patients will be accrued for this study within 1 year.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003312

Show 258 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Colleen A. Lawton, MD

Medical College of Wisconsin

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

Lawton CA, DeSilvio M, Lee WR, Gomella L, Grignon D, Gillin M, Morton G, Pisansky T, Sandler H. Results of a phase II trial of transrectal ultrasound-guided permanent radioactive implantation of the prostate for definitive management of localized adenocarcinoma of the prostate (radiation therapy oncology group 98-05). Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):39-47. Epub 2006 Nov 2.

Feigenberg SJ, Lee WR, Desilvio ML, Winter K, Pisansky TM, Bruner DW, Lawton C, Morton G, Baikadi M, Sandler H. Health-related quality of life in men receiving prostate brachytherapy on RTOG 98-05. Int J Radiat Oncol Biol Phys. 2005 Jul 15;62(4):956-64.

Lawton CA, DeSilvio M, Lee WR, et al.: Correlating prostate seed implant quality with clinical outcomes for patients treated on RTOG protocol 98-05 (a multi-institutional phase II trial of transrectal ultrasound guided prostate seed implant for localized prostate cancer). [Abstract] American Society of Clinical Oncology 2005 Prostate Cancer Symposium, 17-19 February 2005, Orlando, Florida. A-90, 2005.

Lawton CA, DeSilvio M, Lee WR, et al.: Results of a prospective multi-institutional phase II trial (RTOG 98-05) of transrectal ultrasound guided permanent radioactive implantation of the prostate for definitive management of localized adenocarcinoma of the prostate. [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-90, S184, 2004.

Other Publications:

Gillin MT, Dunning BF, Lawton CA, Foley WD, Byhardt RW, Morton G, Baikadi M, Pisansky TT, Michalski JM, Ibbott G, Lopez F; Radiation Therapy Oncology Group. Quality assurance methods for the first Radiation Therapy Oncology Group permanent prostate implant protocol. Brachytherapy. 2006 Jul-Sep;5(3):152-6.

Study ID Numbers:	CDR0000066259, RTOG-9805
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00003312
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I prostate cancer
stage II prostate cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Iodine
Urogenital Neoplasms

Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009