A Pilot Study of High Dose Rate Brachytherapy as Definitive Management for Intermediate Risk Prostate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
OBJECTIVES: Primary * 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%). Secondary * 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity
Time Frame: At scheduled 3 month intervals for one year
Feasibility will be defined as an acceptable level of severe toxicity (both acute and late effects), and adequate dosimetric coverage. Severe toxicity will be defined as \> or = grade 3 NCI CTC toxicity
Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity
Time Frame: Within 90 days of treatment (early toxicities) or after 90 days (late toxicities)
urinary and rectal toxicity-see the adverse event tables