An interventional study of questionnaire administration and quality-of-life assessment in Prostate Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to male participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2017-10-20.
Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Treatment
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's enrollment of 23 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,957 studies on the registry; 323 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 68 (52%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
DISEASE CHARACTERISTICS:
Inclusion criteria:
Intermediate-risk adenocarcinoma of the prostate, defined by 1of the following criteria:
Exclusion criteria:
Evidence of definitive extracapsular extension/seminal vesicle invasion or pelvic adenopathy by MRI (endorectal coil) and DRE (digital rectal examination)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days
Other: questionnaire administration · Procedure: quality-of-life assessment · Radiation: brachytherapy
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
Time frame: 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
Time frame: Within 90 days of treatment (early toxicities) or after 90 days (late toxicities)
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)
Time frame: 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).
Time frame: week 12 reported
| Milestone | HDR Brachytherapy |
|---|---|
| Started | 23 |
| Completed | 21 |
| Not completed | 2 |
| Withdrew: Not treated | 2 |
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
| participants | HDR Brachytherapy |
|---|---|
| Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity | 20 |
urinary and rectal toxicity-see the adverse event tables
| participants | HDR Brachytherapy |
|---|---|
| Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity | 21 |
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)
| participants | HDR Brachytherapy |
|---|---|
| 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 | 3 |
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).
| scores on a scale | HDR Brachytherapy |
|---|---|
| Median International Prostate Symptom Total Score | 5 (2 to 13) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HDR Brachytherapy | — | 2/21 (9.5%) | 11/21 (52.4%) |
| Event | HDR Brachytherapy |
|---|---|
| EsophagitisGastrointestinal disorders | 1/21 |
| Hemorrhage, EsophagusGastrointestinal disorders | 1/21 |
| Event | HDR Brachytherapy |
|---|---|
| Erectile dysfunctionReproductive system and breast disorders | 5/21 |
| Urinary retention (includ neurogenic bladder)Renal and urinary disorders | 5/21 |
| Urinary frequency/urgencyRenal and urinary disorders | 4/21 |
| DiarrheaGastrointestinal disorders | 1/21 |
| Ejaculatory dysfunctionReproductive system and breast disorders | 1/21 |
| Phosphate, low (hypophosphatemia)Metabolism and nutrition disorders | 1/21 |
| Renal/Genitourinary-Other SpecifyRenal and urinary disorders | 1/21 |
| Age, Categorical(Participants) | HDR Brachytherapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 9 |
| Sex: Female, Male(Participants) | HDR Brachytherapy |
|---|---|
| Female | 0 |
| Male | 21 |
| Region of Enrollment(participants) | HDR Brachytherapy |
|---|---|
| United States | 21 |
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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