Clinical trial · Interventional
Prostate-Rectal Separation With PEG Hydrogel and Its Effect on Decreasing Rectal Dose
NCT02212548CI-TRIAL-00052255completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG Hydrogel (SpaceOAR) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hydrogel
- description
- The patient will be in the dorsal lithotomy position and prepared and draped. A transrectal ultrasound (TRUS) will be used for alignment of the needle and to ensure safe delivery. The hydrogel precursor and accelerator solutions will be mixed and connected to the Y connector that has been flushed with saline and to a syringe holder that ensures both syringe barrels are injected at the same time. After aspirating to ensure the tip of the needle is not intravascular, the perirectal space will be adequately dissected from the apex to midgland by injecting saline into the space between denonvilliers fascia and the anterior rectal space under TRUS guidance. Maintaining the needle position and angulation, the saline syringe is disconnected and the hydrogel system connected. After aspirating to ensure the needle tip is not in a blood vessel and under TRUS guidance, the 'PEG Hydrogel (SpaceOAR) is injected in a smooth, continuous technique.
- interventionNames
- Device: PEG Hydrogel (SpaceOAR)
Primary outcomes (2)
- measure
- % volume of rectum receiving 40Gy, 65Gy, 70Gy, 75Gy and 80Gy
- timeFrame
- CT scans taken 1-2 weeks apart (Pre and post Hydrogel insertion)
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (2)
- RESULTJuneja 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;10:215. doi: 10.1186/s13014-015-0526-1. PMID 26499473
- RESULTvan Gysen K, Kneebone A, Alfieri F, Guo L, Eade T. Feasibility of and rectal dosimetry improvement with the use of SpaceOAR(R) hydrogel for dose-escalated prostate cancer radiotherapy. J Med Imaging Radiat Oncol. 2014 Aug;58(4):511-6. doi: 10.1111/1754-9485.12152. Epub 2014 Mar 3. PMID 24580893