Prostate CancerNCT06496256
Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial
A study testing Barrigel and Transrectal Ultrasound in people with Prostate Cancer, run by Palette Life Sciences, Inc. at 13 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Barrigel and Transrectal Ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 31 Oct 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Prostatectomy surgeon notes specifying successful bilateral nerve Sparing procedure
- Documentation of an intra or interfascial radical prostatectomy
- Confirmed diagnosis of adenocarcinoma of the prostate treated primarily with radical prostatectomy with pN0 or pNX pathologic stage
- No radiographic evidence of local, regional, or distant metastatic disease via PSMA PET or Axumin fluciclovine F18 scan
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- Prostate specific antigen (PSA) 0.1 ng/mL or higher
- Intent to receive definitive radiation therapy to the prostate bed
- Written informed consent for study participation prior to study enrollment
Who cannot join
- Known allergy to hyaluronic acid
- Pathologic T4 disease
- Prior local prostate cancer therapy including cryotherapy or brachytherapy.
- Prior post-prostatectomy or pelvic radiation therapy
- Planned elective pelvic lymph node radiation therapy
- Prior anorectal surgery (e.g. low anterior resection, abdominoperineal resection, absence of a rectum)
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- Inflammatory bowel disease requiring treatment with steroids (e.g. Crohn's disease, ulcerative colitis)
- Active connective tissue disorder including lupus or scleroderma
- Any urogenital abnormality that could limit the ability to access the Barrigel injection site
- White blood cell count <4000/uL or >12,000/uL.
- Hemoglobin <10 g/dL (transfusion or other intervention to achieve this is acceptable).
- Active bleeding disorder or clinically significant coagulopathy defined as PTT >35 seconds or INR >1.4 or platelet count <100,000/mm3.
- Serum AST/ALT >2.5 times the institutional upper limit of normal
- Creatinine >2.0 mg/dL
- Bilirubin >2.0 mg/dL
- History of chronic renal failure.
- History of uncontrolled diabetes (e.g. symptomatic hyperglycemia that is not controlled with medical management; fasting blood glucose >300 mg/dL).
- History of acquired immunodeficiency syndrome (AIDS). Patients with controlled HIV infection (CD4+ T-cell counts ≥ 350 cells/µL) and no history of AIDS-defining opportunistic infections may be included.
- Contraindication to having an MRI or PSMA/PET scan (e.g. non-MRI compatible device).
- Presence of bilateral hip implants, although unilateral hip implant may be permissible if the implant is MRI compatible and does not produce artifact that interferes with any requirements of the study protocol
- Subject unable or unwilling to comply with study requirements
- Any condition that in the investigator's opinion would prevent administration or completion of study therapy
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 2 countries
United States11 sites, 7 recruiting
- Recruiting
Augusta University Research Institute
Augusta, Georgia, 30912
Candelario Laserna, MD, 706-721-9680, calaserna@augusta.edu
Zachary Klaassen, MD
- Recruiting
Urology Austin
Austin, Texas, 78745
Jennifer Penshorn, RN, 512-737-9840, jennifer.penshorn@urologyaustin.com
Rebecca Rodriquez, rebecca.rodriguez@urologyaustin.com
- Recruiting
Baptist Health South Florida Inc
Boca Raton, Florida, 33486
Matthew Monrmann, 561-955-7100, Matthew.Montmann@baptisthealth.net
Michael Kasper, MD
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Martin King, MD
Martin_King@DFCI.HARVARD.EDU
- Active, not recruiting
Arizona Clinical Trial
Chandler, Arizona, 85225
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Matthew Ferrebee, 216-844-7064, Matthew.Ferrebee@Uhhospitals.org
Honathan Shoag, MD
- Recruiting
Summit Health
Clifton, New Jersey, 07013
Kelly Ritter, 903-361-0748, KRitter@summithealth.com
Jocelyn Remuska, jremuszka@summithealth.com
- Withdrawn
Houston Metro Urology
Houston, Texas, 77027
- Active, not recruiting
Thomas Jefferson Health Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
- Recruiting
Virginia Urology Center
Richmond, Virginia, 23235
Jordan Moore, 804-288-2785, jnmoore@uro.com
J Daniel Pennington, MD
- Active, not recruiting
Sansum Clinic-Sutter Health
Santa Barbara, California, 93105
Australia2 sites, 2 recruiting
- Not yet recruiting
St. Vincent Hospital
Fitzroy, Victoria, 3065
Maja Djuric, +61392312211, Maja.Djuric@genesiscare.com
Michael Ng, MD
- Recruiting
GenesisCare Ringwood
Melbourne, Victoria, 3002
Michelle Starman, +388703388, michelle.starmans@genesiscare.com
Prof Michael Chao, MD
About this study
Official title: 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
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.
Read the detailed 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 multicenter study.
- Conditions
- Prostate Cancer
- Being tested
- Barrigel, Transrectal Ultrasound
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BarrigelDevice
Barrigel is an absorbable gel based on Non-Animal Stabilized Hyaluronic Acid (NASHA™) that is injected into the peri-rectal space
Transrectal UltrasoundDevice
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 group | Role | What they receive |
|---|---|---|
| Treatment Arms | Experimental | Subjects will be injected Barrigel between the rectum and prostate bed using transrectal ultrasound for guidance. Receives: Device: Barrigel; Device: Transrectal Ultrasound |
| Control Arm | Sham comparator | 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. Receives: Device: Transrectal Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in volume of rectum receiving radiation dose
Investigational subjects only: Achievement of a ≥ 25% change in reduction in the volume of rectum receiving 90% of the prescription dose in 70% of the subjects.
Measured: 3 months
Secondary outcomes (3)
Grade 2 Toxicities
Test whether the use of the Barrigel spacer does not increase the incidence of acute grade 2+ GI toxicity within the first 3 months, which will be assessed using the proportion of subjects who have one or more incidences of acute grade 2+ GI toxicity within the first 3 months.
Measured: 3 Months
Expanded Prostate Cancer Index Composite (EPIC) bowel QOL
Evaluate the change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment composite score (from baseline within 3 months after completion of radiation therapy. The EPIC is graded on a 12 point scale, with a higher score indicating a higher outcome.
Measured: 3 months
Expanded Prostate Cancer Index Composite (EPIC) Urinary QOL
Evaluate the change in Expanded Prostate Cancer Index Composite (EPIC) Urinary Assessment composite score from baseline within 3 months after completion of radiation therapy. The EPIC is graded on a 12 point scale, with a higher score indicating a higher outcome.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start31 Oct 2024
- Primary completion1 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled, single-blinded multicenter study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palette Life Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teleflex
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496256
- Sponsor's protocol ID
- 0423-0001
- Status last verified
- Sep 2026
- First submitted
- 3 Jul 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be submitted to FDA as part of a 510(k). Study data will be shared with other researchers for analysis and reporting after FDA clearance, including protocol, SAP, CSR, and raw data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06496256
- Acronym / sponsor ID
- 0423-0001
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Palette Life Sciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Teleflex
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 multicenter study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled, single-blinded multicenter study
| Arm | Type | Receives |
|---|---|---|
| Treatment Arms | Experimental | Device: Barrigel, Device: Transrectal UltrasoundSubjects will be injected Barrigel between the rectum and prostate bed using transrectal ultrasound for guidance. |
| Control Arm | Sham comparator | Device: Transrectal UltrasoundSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Prostatectomy surgeon notes specifying successful bilateral nerve Sparing procedure
- Documentation of an intra or interfascial radical prostatectomy
- Confirmed diagnosis of adenocarcinoma of the prostate treated primarily with radical prostatectomy with pN0 or pNX pathologic stage
Key exclusion criteria (22 listed)
- Known allergy to hyaluronic acid
- Pathologic T4 disease
- Prior local prostate cancer therapy including cryotherapy or brachytherapy.
- Prior post-prostatectomy or pelvic radiation therapy
- Planned elective pelvic lymph node radiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BarrigelBarrigel is an absorbable gel based on Non-Animal Stabilized Hyaluronic Acid (NASHA™) that is injected into the peri-rectal space | Device | Treatment Arms |
| Transrectal UltrasoundAll 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 | Device | Control Arm, Treatment Arms |
Primary outcome
Reduction in volume of rectum receiving radiation dose
Time frame: 3 months
Investigational subjects only: Achievement of a ≥ 25% change in reduction in the volume of rectum receiving 90% of the prescription dose in 70% of the subjects.
3 secondary outcomes
Grade 2 Toxicities
Time frame: 3 Months
Expanded Prostate Cancer Index Composite (EPIC) bowel QOL
Time frame: 3 months
Expanded Prostate Cancer Index Composite (EPIC) Urinary QOL
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Yes. Data will be submitted to FDA as part of a 510(k). Study data will be shared with other researchers for analysis and reporting after FDA clearance, including protocol, SAP, CSR, and raw data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barrigel and Transrectal Ultrasound in people with Prostate Cancer, run by Palette Life Sciences, Inc. at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Onokwai, MD, MPH, PhD (7738864397, v-jonokwai@palettelifesciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in volume of rectum receiving radiation dose (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.