Status:
COMPLETED
Prostate-Rectal Separation With PEG Hydrogel and Its Effect on Decreasing Rectal Dose
Lead Sponsor:
Royal North Shore Hospital
Conditions:
Cancer of the Prostate
Eligibility:
MALE
Phase:
NA
Brief Summary
This is a Phase I prospective study of 30 patients to determine whether PEG hydrogel (SpaceOAR) reduces the dose of radiation delivered to the rectum during Image Guided Intensity Modulated Radiothera...
Detailed Description
Patients who are referred to the Northern Sydney Cancer Centre for radiotherapy for treatment of their prostate cancer will be screened at the initial consultation for suitability for participation in...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Prostate cancer, confirmed with histopathology specimen;
- Eligible for prostate radiotherapy, either for definitive treatment or to aid local control in patients with known metastatic disease.
- Exclusion criteria:
- Metastatic disease where local radiotherapy is not recommended management
- Complications following prostate biopsy including infection
- Urinary retention symptoms
- Bleeding disorder
- Renal impairment
- Anal fistula or perianal abscess
Exclusion
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02212548
Start Date
March 1 2012
End Date
December 1 2016
Last Update
June 14 2021
Active Locations (1)
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1
Northern Sydney Cancer Centre, Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065