Prostate-Rectal Separation With PEG Hydrogel and Its Effect on Decreasing Rectal Dose

NCT02212548 | Completed DMC

• 1 other identifier: Hydrogel
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 Radiotherapy (IG-IMRT) for prostate cancer, by increasing the space between the prostate and the rectum.

Conditions

Cancer of the Prostate

Keywords

SpaceOAR Hydrogel Image Guided Modulated Radiotherapy

Outcome Measures

Primary Outcomes (2)

• % 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)

• 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 Outcomes (1)

• Gastrointestinal toxicity

  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.

Study Arms (1)

Hydrogel

EXPERIMENTAL

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.

Device: PEG Hydrogel (SpaceOAR)

Interventions

PEG Hydrogel (SpaceOAR) DEVICE

A single injection of PEG hydrogel (SpaceOAR) through the perineum under transrectal ultrasound guidance while under general anaesthetic.

Hydrogel

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal North Shore Hospital: lead

Study Sites (1)

Northern Sydney Cancer Centre, Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Related Publications (2)

• 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;10:215. doi: 10.1186/s13014-015-0526-1.

  PMID: 26499473 RESULT

• van 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 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Thomas Eade, MD

  Royal North Shore Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: August 8, 2014
• Study Start: March 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2016
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)