NCT00949338

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Last Updated

December 31, 2014

Status Verified

January 1, 2014

Enrollment Period

4.3 years

First QC Date

July 29, 2009

Last Update Submit

December 30, 2014

Conditions

Prostate Cancer

Keywords

stage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage IV prostate cancerrecurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Consistency of bladder volumes

    2011

Secondary Outcomes (3)

  • Incidence of acute and late genitourinary and gastrointestinal toxicity

    4 years

  • Patient satisfaction with bladder-filling instructions

    2011

  • Staff satisfaction of bladder-filling protocols

    2011

Study Arms (2)

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.

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.

Procedure: pre-procedural preparation

Interventions

pre-procedural preparationPROCEDURE

Patients empty their bladders and consume 6 cups or 3 cups of water 30 minutes before undergoing radiotherapy.

Arm IArm II

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Saint Luke's Radiation Oncology Network

Dublin, 6, Ireland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Pierre Thirion, MD

    Saint Luke's Hospital

    PRINCIPAL INVESTIGATOR

  • John Gerard Armstrong, MD, MB, MRCPI

    Saint Luke's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2009

First Posted

July 30, 2009

Study Start

March 1, 2006

Primary Completion

June 1, 2010

Last Updated

December 31, 2014

Record last verified: 2014-01

Locations

IE(1)