Prostate CancerNCT00949338
Comparing Two Sets of Bladder-Filling Instructions in Treating Patients Undergoing Radiation Therapy For Prostate Cancer. ICORG 05-04
A study testing pre-procedural preparation in people with Prostate Cancer, run by Cancer Trials Ireland at 1 site in Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- pre-procedural preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteIreland
- Study dates
- Mar 2006to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Trial Comparing The Bladder Volume Consistency Achieved With Two Bladder-Filling Protocols in Prostate Conformal Radiotherapy
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- pre-procedural preparation
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-procedural preparationProcedure or surgery
Patients empty their bladders and consume 6 cups or 3 cups of water 30 minutes before undergoing radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: pre-procedural preparation |
| 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. Receives: Procedure: pre-procedural preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistency of bladder volumes
Measured: 2011
Secondary outcomes (3)
Incidence of acute and late genitourinary and gastrointestinal toxicity
Measured: 4 years
Patient satisfaction with bladder-filling instructions
Measured: 2011
Staff satisfaction of bladder-filling protocols
Measured: 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startMar 2006
- Primary completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Pierre Thirion, MD, Principal investigator, Saint Luke's HospitalJohn Gerard Armstrong, MD, MB, MRCPI, Principal investigator, Saint Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949338
- Sponsor's protocol ID
- 05-04 ICORG
- Other IDs
- ICORG-05-04, EU-20923
- Status last verified
- Jan 2014
- First submitted
- 29 Jul 2009
- Last updated
- 31 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial Comparing The Bladder Volume Consistency Achieved With Two Bladder-Filling Protocols in Prostate Conformal Radiotherapy
- ClinicalTrials.gov ID
- NCT00949338
- Acronym / sponsor ID
- 05-04 ICORG
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Mar 2006
- Primary completion
- Jun 2010 (actual)
- First posted
- 30 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Active comparator | Procedure: pre-procedural preparationPatients 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 | Procedure: pre-procedural preparationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre-procedural preparationPatients empty their bladders and consume 6 cups or 3 cups of water 30 minutes before undergoing radiotherapy. | Procedure or surgery | Arm I, Arm II |
Primary outcome
Consistency of bladder volumes
Time frame: 2011
3 secondary outcomes
Incidence of acute and late genitourinary and gastrointestinal toxicity
Time frame: 4 years
Patient satisfaction with bladder-filling instructions
Time frame: 2011
Staff satisfaction of bladder-filling protocols
Time frame: 2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Thirion, MD principal investigator
Saint Luke's Hospital
John Gerard Armstrong, MD, MB, MRCPI principal investigator
Saint Luke's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre-procedural preparation in people with Prostate Cancer, run by Cancer Trials Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consistency of bladder volumes (time frame: 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.