Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Palette Life Sciences, Inc.
Study ID
NCT06496256
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Barrigel — DEVICE
    Barrigel is an absorbable gel based on Non-Animal Stabilized Hyaluronic Acid (NASHA™) that is injected into the peri-rectal space
  • Transrectal Ultrasound — DEVICE
    All subjects will have a transrectal ultrasound (TRUS) conducted. In the control subjects this will act as a sham procedure. For the investigational subjects, the TRUS will be used to visualize the placement of the needle

Study Details

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.

Key Dates

Start date
Oct 31, 2024
Status verified
May 2025
Primary completion
Dec 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Treatment Arms
    Subjects will be injected Barrigel between the rectum and prostate bed using transrectal ultrasound for guidance.
  • Sham Comparator: Control Arm
    Subjects randomized to the control group will not receive Barrigel but will have a Transrectal ultrasound probe inserted to simulate that aspect of the injection of Barrigel.

Primary Outcome Measure

Reduction in volume of rectum receiving radiation dose [ Time Frame: 3 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215
Martin King, MD
[email protected]
Martin King, MD (PRINCIPAL_INVESTIGATOR)
Summit HealthCliftonNew Jersey07013
Kelly Ritter
[email protected]
903-361-0748
Jocelyn Remuska
[email protected]
Dr. Glen Gejerman, MD (PRINCIPAL_INVESTIGATOR)
Urology AustinAustinTexas78745
Jennifer Penshorn, RN
[email protected]
512-737-9840
Rebecca Rodriquez
[email protected]
Brian Mazzarella, MD (PRINCIPAL_INVESTIGATOR)
Houston Metro UrologyHoustonTexas77027-

Find similar trials in Boston, MA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Dana Farber Cancer Institute· Boston, MASummit Health· Clifton, NJUrology Austin· Austin, TXHouston Metro Urology· Houston, TX

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