Internal Radiation Therapy in Treating Patients With Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00573833|
Recruitment Status : Completed
First Posted : December 14, 2007
Results First Posted : October 20, 2017
Last Update Posted : October 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: questionnaire administration Procedure: quality-of-life assessment Radiation: brachytherapy||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of High Dose Rate Brachytherapy as Definitive Management for Intermediate Risk Prostate Cancer|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Experimental: HDR Brachytherapy
9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days
Other: questionnaire administration
Procedure: quality-of-life assessment
- 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
- Number of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint [ Time Frame: week 12 reported ]Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the number of participants who return to normal erectile function (IIEF-EF domain score ≥26)
- Median International Prostate Symptom Total Score [ Time Frame: week 12 reported ]Quality of life will be assessed with the MSKCC prostate quality of life instrument. International prostate symptom score index (IPSS). The IPSS index is a seven item questionnaire designed to assess urinary functioning, specifically urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Questions are rated on a six point Likert scale with higher scores indicating more difficulty in urinary functioning. This measure demonstrated a high internal consistency (Cronbach's alpha = 0.84) with excellent test-retest reliability (r = 0.92).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|