Using a hydrogel spacer to reduce side effects of salvage radiation for prostate cancer
Feasibility of Integrating Rectal Hydrogel Spacer for Salvage Treatment Using Stereotactic Ablative Body Radiotherapy for Locally Recurrent Prostate Cancer
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05597852 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men with histologically confirmed locally recurrent prostate adenocarcinoma who are willing to participate and complete quality of life assessments.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- Sunnybrook Odette Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Amandeep Taggar, MD — Sunnybrook
- Study coordinator: Amandeep Taggar, MD
- Email: aman.taggar@sunnybrook.ca
- Phone: 416 480 6165
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.