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Clinical trial Recruiting at 1 site Interventional Ages 18 and up Men only

Using a hydrogel spacer to reduce side effects of salvage radiation for prostate cancer

Official title: Feasibility of Integrating Rectal Hydrogel Spacer for Salvage Treatment Using Stereotactic Ablative Body Radiotherapy for Locally Recurrent Prostate Cancer

Run by Sunnybrook Health Sciences Centre · NCT05597852 · Data updated 2026-11-12

This study is testing whether a special gel placed between the prostate and rectum can help reduce side effects from radiation treatment in men with recurring prostate cancer.

More Prostate Cancer trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment10 (estimated)
SponsorSunnybrook Health Sciences Centre
Academic / other
Drugs / interventionsradiation
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedNovember 30, 2021
Main results expectedNovember 30, 2022
Study endsNovember 30, 2027
Registry record updatedOctober 28, 2022
Trial IDNCT05597852 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men with histologically confirmed locally recurrent prostate adenocarcinoma who are willing to participate and complete quality of life assessments.

Probably not a fit

Patients with contraindications to prostate MRI, those on anticoagulation medications, or those with advanced metastatic disease may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of a biodegradable hydrogel spacer placed between the prostate and rectum to minimize gastrointestinal toxicity during salvage stereotactic ablative radiotherapy (SABR) for patients with locally recurrent prostate cancer. The study will assess the safety and feasibility of this intervention, focusing on improving bowel quality of life and reducing the risk of complications such as fistula development. Participants will be monitored for their gastrointestinal and genitourinary side effects following treatment, and their quality of life will be evaluated through standardized questionnaires.

Why it matters

Potential benefit: If successful, this approach could significantly reduce gastrointestinal side effects for patients undergoing salvage radiation therapy for prostate cancer.

How similar studies have gone: While there have been single institutional series on salvage radiotherapy, the use of a hydrogel spacer in this context is a novel approach that has not been extensively tested in larger studies.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Histologically and radiologically confirmed locally recurrent prostate adenocarcinoma
* Willing to give informed consent to participate in this clinical trial
* Able and willing to complete EPIC and EQ-5D questionnaires

Exclusion Criteria:

* Contraindication to prostate MRI
* Anticoagulation medication (if unsafe to discontinue)
* Diagnosis of bleeding diathesis
* Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>20
* Evidence of castrate resistance (defined as PSA \> 3 ng/ml while testosterone is \< 0.7nmol/l). Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
* Definitive extrapelvic nodal or distant metastatic disease on staging investigations.
* Prior ultra-hypofractionated radiotherapy ( SBRT of 5Gy/fraction or higher)

Where it's running

  • Sunnybrook Odette Cancer Centre
    Toronto, Ontario, Canada     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.