Using Rectal Hydrogel Spacer for Salvage SABR in Prostate Cancer
Feasibility of Integrating Rectal Hydrogel Spacer for Salvage Treatment Using Stereotactic Ablative Body Radiotherapy for Locally Recurrent Prostate Cancer
About This Trial
- This study is testing whether placing a temporary, protective gel between the prostate and the bowel can reduce side effects for men needing a second round of radiation therapy.
- It is designed for patients whose prostate cancer has returned in the prostate area but has not spread to other parts of the body.
- The gel acts as a cushion to shield the bowel from high-dose radiation, with the goal of preventing long-term digestive problems and maintaining your quality of life.
- Before considering this trial, you should know that you must be able to have an MRI, cannot have severe urinary issues or serious bleeding risks, and will be asked to complete surveys about your everyday health.
More Information
- 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.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is testing whether placing a temporary, protective gel between the prostate and the bowel can reduce side effects for men needing a second round of radiation therapy.
Study Details
- Start Date: November 30, 2021
- Lead Sponsor: Sunnybrook Health Sciences Centre
Full Eligibility 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)
Treatments
- Device: SpaceOAR