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| ID | Type | Description | Link |
|---|---|---|---|
| ICORG-05-04 | |||
| EU-20923 |
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RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Having a full bladder may improve the effectiveness of radiation therapy to the bladder. It is not yet known which set of bladder-filling instructions is more effective in helping patients keep their bladder full during radiation therapy.
PURPOSE: This randomized clinical trial is comparing two sets of bladder-filling instructions in treating patients with prostate cancer undergoing radiation therapy.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
In both arms, patients follow their bladder filling instructions and then undergo conformal radiation therapy daily for about 8 weeks.
Patients' perception of symptoms, quality of life, and urinary symptoms are assessed periodically by the International Prostate Symptom Score (I-PSS). Patients' satisfaction with the bladder-filling instructions (i.e., ability to comply with the bladder-filling protocol, the number of incidents of wetting accidents, number of incidents of having to repeat the water drinking on the same day due to machine breakdown or the patient's inability to retain the full bladder for the required amount of time, and the level of frustration) is assessed periodically by the Visual Analogue Scale (VAS).
Staff satisfaction with bladder-filling interventions (i.e., patient compliance with the protocols, acceptance of bladder dose-volume histograms [DVHs], need for re-scan with a fuller bladder, amount of disruption to the therapist's work schedule, number of incidents of wetting accidents, number of incidents of having to repeat the water drinking on the same day due to machine breakdown or the patient's inability to retain the full bladder for the required amount of time, and the level of satisfaction or frustration) is assessed periodically.
After completion of study treatment, patients are followed up periodically for 4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Active Comparator | Patients empty their bladders and consume 6 cups of water 30 minutes before undergoing radiotherapy. Patients also undergo bladder volume measurements using a bladder volume instrument (BVI) periodically during treatment. |
|
| Arm II | Experimental | Patients empty their bladders and consume 3 cups of water 30 minutes before undergoing radiotherapy. Patients also undergo bladder volume measurements using a BVI periodically during treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pre-procedural preparation | Procedure | Patients empty their bladders and consume 6 cups or 3 cups of water 30 minutes before undergoing radiotherapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Consistency of bladder volumes | 2011 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute and late genitourinary and gastrointestinal toxicity | 4 years | |
| Patient satisfaction with bladder-filling instructions | 2011 | |
| Staff satisfaction of bladder-filling protocols |
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DISEASE CHARACTERISTICS:
Diagnosis of prostate cancer
Undergoing a radical course of radiotherapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Thirion, MD | Saint Luke's Hospital | Principal Investigator |
| John Gerard Armstrong, MD, MB, MRCPI | Saint Luke's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Luke's Radiation Oncology Network | Dublin | 6 | Ireland |
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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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| 2011 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |