ACTRN12614000858695
Terminated
Phase 2
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 Centre0 sites18 target enrollmentAugust 11, 2014
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Castrate Resistant Prostate Cancer
- Sponsor
- Radiation Oncology Services - Mater Centre
- Enrollment
- 18
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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