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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02212548




Registration number
NCT02212548
Ethics application status
Date submitted
5/06/2012
Date registered
8/08/2014
Date last updated
14/06/2021

Titles & IDs
Public title
Prostate-Rectal Separation With PEG Hydrogel and Its Effect on Decreasing Rectal Dose
Scientific title
Prostate-Rectal Separation With PEG Hydrogel and Its Effect on Decreasing Rectal Dose
Secondary ID [1] 0 0
Hydrogel
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer of the Prostate 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - PEG Hydrogel (SpaceOAR)

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.


Treatment: Devices: PEG Hydrogel (SpaceOAR)
A single injection of PEG hydrogel (SpaceOAR) through the perineum under transrectal ultrasound guidance while under general anaesthetic.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
% volume of rectum receiving 40Gy, 65Gy, 70Gy, 75Gy and 80Gy
Timepoint [1] 0 0
CT scans taken 1-2 weeks apart (Pre and post Hydrogel insertion)
Primary outcome [2] 0 0
Evaluation of serious adverse events or complications secondary to PEG hydrogel insertion.
Timepoint [2] 0 0
Post-Hydrogel Insertion then 2nd weekly during radiation therapy up to 9 weeks and at a 3 month follow-up.
Secondary outcome [1] 0 0
Gastrointestinal toxicity
Timepoint [1] 0 0
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.

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Northern Sydney Cancer Centre, Royal North Shore Hospital - St. Leonards
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02212548
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Eade, MD
Address 0 0
Royal North Shore Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02212548