Actively Recruiting
Using Rectal Hydrogel Spacer for Salvage SABR in Prostate Cancer
Led by Sunnybrook Health Sciences Centre · Updated on 2022-10-28
10
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
There are several single institutional series that have reported their experience with salvage radiotherapy options that include EBRT, LDR and HDR brachytherapy. Gastrointestinal (GI) toxicity with salvage radiotherapy range between14-58%, respectively for patients undergoing re-irradiation. There is a concern for an increased risk of fistula development in these patients who receive second course of radiation. Hypofractionation using SABR has been utilized in the re-irradiation setting for prostate cancer with good tumor control and toxicity outcomes. In order to decrease the rectal toxicity, dose to the rectum should be kept as low as possible. Several techniques can be used to achieve this: tighter dosimetric dose painting, better patient or organ immobilization or use of a biodegradable gel. The Investigators ropose a phase I study to assess placement of a hydrogel spacer between the prostate and rectum, in an effort to decrease toxicity and improve patient's bowel quality of life.
CONDITIONS
Official Title
Using Rectal Hydrogel Spacer for Salvage SABR in Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Contraindication to prostate MRI
- Use of anticoagulation medication if unsafe to discontinue
- Diagnosis of bleeding diathesis
- Poor baseline urinary function with International Prostate Symptom Score (IPSS) greater than 20
- Evidence of castrate resistance defined as PSA greater than 3 ng/ml with testosterone less than 0.7 nmol/l, excluding those who started combined androgen blockade due to PSA progression
- Definitive extrapelvic nodal or distant metastatic disease on staging
- Prior ultra-hypofractionated radiotherapy (SBRT of 5Gy/fraction or higher)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
Research Team
A
Amandeep Taggar, MD
CONTACT
A
Andrea DeAbreu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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