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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02212548
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : June 14, 2021
Information provided by (Responsible Party):
Professor Thomas Eade, Royal North Shore Hospital

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.

Condition or disease Intervention/treatment Phase
Cancer of the Prostate Device: PEG Hydrogel (SpaceOAR) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prostate-Rectal Separation With PEG Hydrogel and Its Effect on Decreasing Rectal Dose
Actual Study Start Date : March 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Hydrogel
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)
A single injection of PEG hydrogel (SpaceOAR) through the perineum under transrectal ultrasound guidance while under general anaesthetic.

Primary Outcome Measures :
  1. % volume of rectum receiving 40Gy, 65Gy, 70Gy, 75Gy and 80Gy [ Time Frame: CT scans taken 1-2 weeks apart (Pre and post Hydrogel insertion) ]
    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).

  2. Evaluation of serious adverse events or complications secondary to PEG hydrogel insertion. [ Time Frame: Post-Hydrogel Insertion then 2nd weekly during radiation therapy up to 9 weeks and at a 3 month follow-up. ]
    Physcian reported toxicity using CTC

Secondary Outcome Measures :
  1. Gastrointestinal toxicity [ Time Frame: 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. ]
    Patients will be physician scored using the CTC and patient scored using the EPIC QOL questionaire

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02212548

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Australia, New South Wales
Northern Sydney Cancer Centre, Royal North Shore Hospital
St. Leonards, New South Wales, Australia, 2065
Sponsors and Collaborators
Royal North Shore Hospital
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Principal Investigator: Thomas Eade, MD Royal North Shore Hospital
Publications of Results:
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Responsible Party: Professor Thomas Eade, Dr., Royal North Shore Hospital Identifier: NCT02212548    
Other Study ID Numbers: Hydrogel
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Other centres with ethics approval to use annonymised data
Keywords provided by Professor Thomas Eade, Royal North Shore Hospital:
SpaceOAR Hydrogel Image Guided Modulated Radiotherapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases