Cancer of the Prostate Clinical Trial
Official title:
Prostate-Rectal Separation With PEG Hydrogel and Its Effect on Decreasing Rectal Dose
NCT number | NCT02212548 |
Other study ID # | Hydrogel |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2012 |
Est. completion date | December 2016 |
Verified date | June 2021 |
Source | Royal North Shore Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 Radiotherapy (IG-IMRT) for prostate cancer, by increasing the space between the prostate and the rectum.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2016 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Prostate cancer, confirmed with histopathology specimen; 2. Eligible for prostate radiotherapy, either for definitive treatment or to aid local control in patients with known metastatic disease. Exclusion criteria: 1. Metastatic disease where local radiotherapy is not recommended management 2. Complications following prostate biopsy including infection 3. Urinary retention symptoms 4. Bleeding disorder 5. Renal impairment 6. Anal fistula or perianal abscess |
Country | Name | City | State |
---|---|---|---|
Australia | Northern Sydney Cancer Centre, Royal North Shore Hospital | St. Leonards | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Royal North Shore Hospital |
Australia,
Juneja P, Kneebone A, Booth JT, Thwaites DI, Kaur R, Colvill E, Ng JA, Keall PJ, Eade T. Prostate motion during radiotherapy of prostate cancer patients with and without application of a hydrogel spacer: a comparative study. Radiat Oncol. 2015 Oct 24;10:2 — View Citation
van Gysen K, Kneebone A, Alfieri F, Guo L, Eade T. Feasibility of and rectal dosimetry improvement with the use of SpaceOAR® hydrogel for dose-escalated prostate cancer radiotherapy. J Med Imaging Radiat Oncol. 2014 Aug;58(4):511-6. doi: 10.1111/1754-9485 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | % volume of rectum receiving 40Gy, 65Gy, 70Gy, 75Gy and 80Gy | Estimated % volume of rectum as measured on CT dosimetry based on CT scans ore and post insertion of hydrogel taken 1-2 weeks apart (% volume of rectum receiving 40Gy, 65Gy, 70Gy, 75Gy and 80Gy). | CT scans taken 1-2 weeks apart (Pre and post Hydrogel insertion) | |
Primary | Evaluation of serious adverse events or complications secondary to PEG hydrogel insertion. | Physcian reported toxicity using CTC | Post-Hydrogel Insertion then 2nd weekly during radiation therapy up to 9 weeks and at a 3 month follow-up. | |
Secondary | Gastrointestinal toxicity | Patients will be physician scored using the CTC and patient scored using the EPIC QOL questionaire | Second weekly evaluation during radiation therapy up to 9 weeks and at 3 mths, 9 mths, 15 mths, 21 mths, 27mths and 36mths post treatment. |
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