Comparing Two Sets of Bladder-Filling Instructions in Treating Patients Undergoing Radiation Therapy For Prostate Cancer. ICORG 05-04

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00949338
First received: July 29, 2009
Last updated: April 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Prostate Cancer
Procedure: pre-procedural preparation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Trial Comparing The Bladder Volume Consistency Achieved With Two Bladder-Filling Protocols in Prostate Conformal Radiotherapy

Resource links provided by NLM:


Further study details as provided by ICORG- All Ireland Cooperative Oncology Research Group:

Primary Outcome Measures:
  • Consistency of bladder volumes [ Time Frame: 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of acute and late genitourinary and gastrointestinal toxicity [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Patient satisfaction with bladder-filling instructions [ Time Frame: 2011 ] [ Designated as safety issue: No ]
  • Staff satisfaction of bladder-filling protocols [ Time Frame: 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment: 183
Study Start Date: March 2006
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
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.
Procedure: pre-procedural preparation
Patients empty their bladders and consume 6 cups or 3 cups of water 30 minutes before undergoing radiotherapy.
Experimental: Arm II
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.
Procedure: pre-procedural preparation
Patients empty their bladders and consume 6 cups or 3 cups of water 30 minutes before undergoing radiotherapy.

Detailed Description:

OBJECTIVES:

Primary

  • To compare the consistency in bladder volumes in patients with prostate cancer undergoing conformal radiotherapy, when randomized to one of two sets of bladder-filling instructions.

Secondary

  • To compare the incidence of acute and late genitourinary and gastrointestinal toxicity in patients treated with these methods.
  • To determine patient satisfaction with the bladder-filling instructions.
  • To determine satisfaction of bladder-filling protocols amongst radiation therapists and doctors.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

  • Arm I: 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: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of prostate cancer
  • Undergoing a radical course of radiotherapy

    • Planned treatment in the supine position

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • No history of urinary incontinence or urinary catheterization
  • No evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial or if it is felt by the research/medical team that the patient may not be able to comply with the protocol
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No previous surgery for urinary conditions, except transurethral resection of the prostate (TURP)
  • Prior transrectal ultrasound (TRUS) allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949338

Locations
Ireland
Saint Luke's Radiation Oncology Network
Dublin, Ireland, 6
Sponsors and Collaborators
ICORG- All Ireland Cooperative Oncology Research Group
Investigators
Principal Investigator: Pierre Thirion, MD Saint Luke's Hospital
Principal Investigator: John Gerard Armstrong, MD, MB, MRCPI Saint Luke's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier: NCT00949338     History of Changes
Other Study ID Numbers: CDR0000639285, ICORG-05-04, EU-20923
Study First Received: July 29, 2009
Last Updated: April 16, 2014
Health Authority: Ireland: Irish Medicines Board

Keywords provided by ICORG- All Ireland Cooperative Oncology Research Group:
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014