A multi-site study to investigate the optimal bladder filling instructions for prostate cancer patients undergoing radical radiation therapy using Image Guided Radiation Therapy (IGRT) to verify daily bladder volume

A multi-site study to investigate the optimal bladder filling instructions for prostate cancer patients undergoing radical radiation therapy by comparing two different sets of bladder filling instructions (300mL vs. 750mL) and using Image Guided Radiation Therapy (IGRT) to verify daily bladder volume

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000774224

Enrollment

210

Registered

2009-09-07

Start date

2009-09-07

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to determine the optimal bladder filling instructions for prostate cancer patients undergoing radical radiation therapy using Image Guided Radiation Therapy (IGRT) Who is it for? You can join this study if you are undergoing radical radiation therapy using Image Guided Radiation Therapy (IGRT) as treatment for prostate cancer. Trial details Participants will be divided into two groups. One group will be asked to empty their bladder 1 hour prior to their treatment appointment time, and then consume 300mL of water at least 30 minutes prior to their treatment appointment time. The second group will be asked to empty their bladder 1 hour prior to their treatment appointment time, and then consume 750mL of water at least 30 minutes prior to their treatment appointment time. The amount of daily bladder volume variation over the course of treatment will be measured daily in week 1 of treatment, and then every 2nd day until treatment is completed. Participants will also be asked to complete some questions measuring quality of life and distress, in weeks 1, 4 an 7 of treatment. Further monitoring will occur 6months and 12 months after treatment has completed.

Interventions

300mL bladder filling instruction. Patients are instructed to empty their bladder 1 hour prior to every treatment appointment time (including their planning appointment and up to 39 treatment appointments) and then consume 300mL of water (as measured in the water bottle provided) at least 30 minutes prior to every treatment appointment time

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

60 Years to No maximum

Healthy volunteers

Inclusion criteria

Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Histological confirmation of adenocarcinoma of the prostate Prescribed radical radiation therapy with dose between 70-78Gy Written informed consent Ability to document information in patient diary in English Ability to complete Quality of Life (QoL) assessments in English

Exclusion criteria

Previous pelvic Radiation Therapy Hip prothesis Concurrrent or previous malignancy within 5 years prior to randomisation (except non-melanomatous skin cancer) Urinary catheter Urinary incontinence Urinary outflow obstruction Already participating in another clinical study Inflammatory bowel disease Patients whose planned bladder volume is deemed unacceptable by their treating radiation oncologist

Outcome results