Internal Radiation Therapy in Treating Patients With Prostate Cancer
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells.
PURPOSE: This clinical trial is studying the side effects and how well internal radiation therapy works in treating patients with prostate cancer.
Other: questionnaire administration
Procedure: quality-of-life assessment
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of High Dose Rate Brachytherapy as Definitive Management for Intermediate Risk Prostate Cancer|
- Feasibility [ Time Frame: At scheduled 3 month intervals for one year ] [ Designated as safety issue: No ]
- Toxicity as assessed by NCI CTC and the International Prostate Symptom Score Index [ Time Frame: Within 90 days of treatment (early toxicities) or after 90 days (late toxicities) ] [ Designated as safety issue: Yes ]
- Quality of life as measured by the MSKCC Prostate Quality of Life questionnaire [ Time Frame: At scheduled 3 month intervals for one year ] [ Designated as safety issue: No ]
- Sexual function as measured by the International Index of Erectile Function (IIEF) [ Time Frame: At scheduled 3 month intervals for one year ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: HDR Brachytherapy
9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days
|Other: questionnaire administration Procedure: quality-of-life assessment Radiation: brachytherapy|
- To assess the feasibility of high-dose rate (HDR) brachytherapy (without the use of external-beam radiotherapy) as definitive treatment for patients with intermediate-risk prostate cancer.
- To assess acceptable toxicity, defined as treatment related toxicity (urinary and rectal), no worse than that seen by patients treated with conventional therapy (grade 3 urinary toxicity < 10% and grade 3 rectal toxicity < 10%).
- To achieve adequate dosimetric coverage of the prostate comparable to current standards.
- To assess the effect of treatment on sexual function.
OUTLINE: Patients undergo 4 high-dose rate brachytherapy treatments over 2 days.
Patients complete bladder, bowel, sexual function, and quality of life questionnaires, including the International Index of Erectile Function (IIEF) questionnaire, the International Prostate Symptom Score Index (IPSS), and the MSKCC Prostate Quality of Life questionnaire at baseline and then at every follow-up visit.
After completion of study treatment, patients are followed every 3 months for 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573833
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Josh Yamada, MD||Memorial Sloan-Kettering Cancer Center|
|Principal Investigator:||Michael J. Zelefsky, MD||Memorial Sloan-Kettering Cancer Center|
|Principal Investigator:||Sherri M. Donat, MD||Memorial Sloan-Kettering Cancer Center|
|Principal Investigator:||Marco Zaider, PhD||Memorial Sloan-Kettering Cancer Center|