A single arm, prospective Phase II study of Split-Course Pelvic Radiotherapy for Locally Progressive, Castrate Resistant Prostate Cancer
A single arm, prospective Phase II study to evaluate the effect of Split-Course Pelvic Radiotherapy on bladder and bowel health related quality of life in patients with locally progressive, castrate resistant prostate cancer.
Radiation Oncology Services - Mater Centre
20 participants
Feb 17, 2015
Interventional
Conditions
Summary
This study aims to prospectively evaluate the palliative benefit of a split course of pelvic radiotherapy in patients with prostate cancer whose disease is no longer responding to hormone therapy. Who is it for? You may be eligible to join this study if you are a male aged 18 years or above who has been diagnosed with castrate resistant prostate cancer, and are able to commence radiotherapy within 6 weeks of trial registration. Study details All participants in this study will undergo split-course pelvic radiotherapy, which consists of 10 treatment sessions over 2 weeks, followed by a planned 1 week treatment break, followed by a further 12 treatment sessions administered over 2.5 weeks. Participants will be asked to complete a questionnaire at 6 months post treatment to assess bowel and bladder related quality of life. They will also be monitored for up to 3 years in order to evaluate acute and late side effects of treatment, local symptom response rate, rates of catheter removal, blood transfusions, trans-urethral prostate resections, and overall survival.
Eligibility
Inclusion Criteria18
- Aged 18 years or older
- Has provided written Informed Consent for participation in this trial
- Histological or cytologically confirmed prostate cancer or where diagnosis made on clinical factors, a PSA >100ug/L at diagnosis
- Castrate resistant disease, as defined by a rising PSA despite castrate levels of testosterone <0.5 ug/L
- Patient has symptoms attributable to local disease progression OR is asymptomatic with T3 or T4 disease but and felt to be at risk of symptomatic local progression (these patients to be included in analysis of secondary endpoints 1, 3 and 4)
- An ECOG performance status score of 2 or less
- Life expectancy at least 6 months
- Available for follow up at least via a phone interview.
- Radiotherapy can commence within 6 weeks of trial registration.
- Is able to complete QOL assessments
Exclusion Criteria6
- Previous radiotherapy to the pelvis
- Bilateral hip replacement surgery
- Cytotoxic chemotherapy within 4 weeks of the proposed start date for radiotherapy
- Prior diagnosis of cancer within 5 years of current diagnosis with the exception of successfully treated non-melanoma skin cancer
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Interventions
Split-course pelvic radiotherapy will consist of a dose of 55Gy in 22 fractions. This dose will be prescribed as a course of 25Gy in 10 fractions given over 2 weeks, followed by a planned 1 week treatment break, followed by a further 30Gy in 12 fractions given over 2 1/2 weeks.
Locations(3)
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ACTRN12614000858695