Randomized Trial of Barrigel® to Increase Distance Between the Rectum and Prostate Bed to Decrease Rectal Dose in Patients Receiving Moderately Hypofractionated Radiation Therapy Who Have Had Recurrence of Prostate Cancer After Prostatectomy
Palette Life Sciences, Inc.
Summary
Barrigel is intended to temporarily position the anterior rectal wall away from the prostate or prostate bed during radiotherapy treatment for prostate cancer and, in creating this space, it is the intent of Barrigel to reduce the radiation dose delivered to the anterior rectum.
Description
Barrigel is composed of biodegradable material and maintains space for the entire course of prostate or prostate bed radiotherapy and is intended to be absorbed by the patient's body over time. To evaluate the safety and effectiveness of Barrigel to reduce the radiation dose delivered to the anterior rectum by creating a space when injected between the rectum and the prostate bed in men receiving definitive external beam radiation therapy (intensity-modulated radiation therapy) for recurrence of prostate cancer after radical prostatectomy. A prospective, randomized, controlled, single-masked…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 3. Prostatectomy surgeon notes specifying successful bilateral nerve Sparing procedure 4. Documentation of an intra or interfascial radical prostatectomy 5. Confirmed diagnosis of adenocarcinoma of the prostate treated primarily with radical prostatectomy with pN0 or pNX pathologic stage 6. No radiographic evidence of local, regional, or distant metastatic disease via PSMA PET or Axumin fluciclovine F18 scan 7. Prostate specific antigen (PSA) 0.1 ng/mL or higher 8. Intent to receive…