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| ID | Type | Description | Link |
|---|---|---|---|
| MSKCC-07120 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDR Brachytherapy | Experimental | 9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaire administration | Other |
| ||
| quality-of-life assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity | 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 | At scheduled 3 month intervals for one year |
| Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity | urinary and rectal toxicity-see the adverse event tables | Within 90 days of treatment (early toxicities) or after 90 days (late toxicities) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Intermediate-risk adenocarcinoma of the prostate, defined by 1of the following criteria:
Less than 20% risk of seminal vesicle involvement or lymph node involved based upon the Kattan nomogram (pre-treatment risk with IMRT)
Prostate size < 60 cc by MRI or CT imaging
International Prostate Symptom Score Index ≤ 15
Exclusion criteria:
Evidence of definitive extracapsular extension/seminal vesicle invasion or pelvic adenopathy by MRI (endorectal coil) and DRE (digital rectal examination)
PSA > 20 ng/mL
Presence of distant metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | HDR Brachytherapy | 9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days questionnaire administration quality-of-life assessment brachytherapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HDR Brachytherapy | 9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days questionnaire administration quality-of-life assessment brachytherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity | 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 | Posted | Number | participants | At scheduled 3 month intervals for one year |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HDR Brachytherapy | 9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days questionnaire administration quality-of-life assessment brachytherapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophagitis | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Josh Yoshiya Yamada, Assistant Attending | Memorial Sloan Kettering Cancer Center | +1212-639-2950 | yamadaj@mskcc.org |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Procedure |
|
| brachytherapy | Radiation |
|
| week 12 reported |
| Median International Prostate Symptom Total Score | 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). | week 12 reported |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity | urinary and rectal toxicity-see the adverse event tables | Posted | Number | participants | Within 90 days of treatment (early toxicities) or after 90 days (late toxicities) |
|
|
|
| Other Pre-specified | 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 | 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) | Posted | Number | participants | week 12 reported |
|
|
|
| Other Pre-specified | Median International Prostate Symptom Total Score | 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). | Posted | Median | Full Range | scores on a scale | week 12 reported |
|
|
|
| 2 |
| 21 |
| 11 |
| 21 |
| Hemorrhage, Esophagus | Gastrointestinal disorders | Systematic Assessment |
|
| Ejaculatory dysfunction | Reproductive system and breast disorders | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | Systematic Assessment |
|
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | Systematic Assessment |
|
| Renal/Genitourinary-Other Specify | Renal and urinary disorders | Systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | Systematic Assessment |
|
| Urinary retention (includ neurogenic bladder) | Renal and urinary disorders | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |