Prostate Cancer Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Sunnybrook Odette Cancer Centre
RECRUITING
Toronto
Contact Information
Primary
Amandeep Taggar, MD
aman.taggar@sunnybrook.ca
416 480 6165
Backup
Andrea DeAbreu
Andrea.Deabreu@sunnybrook.ca
416 480 5000
Time Frame
Start Date: 2021-11-30
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 10
Treatments
Experimental: Study Arm
All patients with local recurrence of prostate cancer post irradiation will undergo placement of a hydrogel spacer between the prostate and rectum, in an effort to decrease toxicity and improve patient's bowel quality of life prior to SABR.
Related Therapeutic Areas
Sponsors
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov