Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests Barrigel during radiation treatment for prostate cancer after surgery to remove the prostate. Barrigel temporarily moves the rectum away from the area where the prostate was, with the goal of lowering the radiation dose to the rectum.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older.
- Be fully active or able to do light work, even if heavy activity is limited.
- Have surgery records showing that the prostate was removed using an intrafascial or interfascial method, with nerves on both sides successfully spared.
- Have confirmed prostate adenocarcinoma, a type of prostate cancer, treated mainly by removing the prostate. Lymph nodes must be cancer-free or not tested.
- Have no signs of cancer spread nearby or elsewhere on a PSMA PET or Axumin scan.
- Have a PSA blood test result of 0.1 ng/mL or higher.
- Plan to have radiation treatment to the area where the prostate was.
- Give written consent before joining the study.
Who can't join
- Have a known allergy to hyaluronic acid, or have T4 prostate cancer, meaning cancer has grown into nearby structures.
- Have had local prostate cancer treatments such as freezing treatment or radioactive seed treatment; radiation after prostate removal or to the pelvis; or planned radiation to pelvic lymph nodes.
- Have had surgery on the anus or rectum; bowel disease needing steroids, such as Crohn’s disease or ulcerative colitis; an active connective tissue disease, such as lupus or scleroderma; or a urinary or genital problem that blocks access to the injection site.
- Have a white blood cell count below 4,000 or above 12,000/uL, or hemoglobin below 10 g/dL. Hemoglobin carries oxygen in blood; treatment to raise it is allowed. Active bleeding or serious clotting problems also exclude you, including PTT above 35 seconds, INR above 1.4, or platelets below 100,000/mm3.
- Have liver tests called AST or ALT above 2.5 times the lab’s normal upper limit, creatinine or bilirubin above 2.0 mg/dL, or a history of long-term kidney failure.
- Have a history of uncontrolled diabetes or AIDS. Controlled HIV may be allowed if CD4 immune cell counts are at least 350 cells/µL and there is no history of AIDS-related infections.
- Cannot safely have an MRI or PSMA/PET scan, or have both hips replaced. One hip implant may be allowed if it is MRI-safe and does not interfere with study images.
- Cannot or will not follow study requirements, or have any condition the study doctor believes would prevent starting or finishing study treatment.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 definitive radiation therapy to the prostate bed 9. Written informed consent for study participation prior to study enrollment Exclusion Criteria: 1. Known allergy to hyaluronic acid 2. Pathologic T4 disease 3. Prior local prostate cancer therapy including cryotherapy or brachytherapy. 4. Prior post-prostatectomy or pelvic radiation therapy 5. Planned elective pelvic lymph node radiation therapy 6. Prior anorectal surgery (e.g. low anterior resection, abdominoperineal resection, absence of a rectum) 7. Inflammatory bowel disease requiring treatment with steroids (e.g. Crohn's disease, ulcerative colitis) 8. Active connective tissue disorder including lupus or scleroderma 9. Any urogenital abnormality that could limit the ability to access the Barrigel injection site 10. White blood cell count \<4000/uL or \>12,000/uL. 11. Hemoglobin \<10 g/dL (transfusion or other intervention to achieve this is acceptable). 12. Active bleeding disorder or clinically significant coagulopathy defined as PTT \>35 seconds or INR \>1.4 or platelet count \<100,000/mm3. 13. Serum AST/ALT \>2.5 times the institutional upper limit of normal 14. Creatinine \>2.0 mg/dL 15. Bilirubin \>2.0 mg/dL 16. History of chronic renal failure. 17. History of uncontrolled diabetes (e.g. symptomatic hyperglycemia that is not controlled with medical management; fasting blood glucose \>300 mg/dL). 18. 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. 19. Contraindication to having an MRI or PSMA/PET scan (e.g. non-MRI compatible device). 20. 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 21. Subject unable or unwilling to comply with study requirements 22. Any condition that in the investigator's opinion would prevent administration or completion of study therapy
Study sites (11)
AZ
- Arizona Clinical Trial · Chandler, AZ 85225More trials in Chandler
CA
- Sansum Clinic-Sutter Health · Santa Barbara, CA 93105More trials in Santa Barbara
FL
- Baptist Health South Florida Inc · Boca Raton, FL 33486Matthew Monrmann · Study contact · 561-955-7100 · Matthew.Montmann@baptisthealth.netMichael Kasper, MD · Principal investigatorMore trials in Boca Raton
GA
- Augusta University Research Institute · Augusta, GA 30912Candelario Laserna, MD · Study contact · 706-721-9680 · calaserna@augusta.eduZachary Klaassen, MD · Principal investigatorMore trials in Augusta
MA
- Dana Farber Cancer Institute · Boston, MA 02215Martin King, MD · Study contact · Study contact · Martin_King@DFCI.HARVARD.EDUMartin King, MD · Principal investigatorMore trials in Boston
NJ
- Summit Health · Clifton, NJ 07013Kelly Ritter · Study contact · 903-361-0748 · KRitter@summithealth.comJocelyn Remuska · Study contact · jremuszka@summithealth.comDr. Glen Gejerman, MD · Principal investigatorMore trials in Clifton
OH
- University Hospitals Cleveland Medical Center · Cleveland, OH 44106Matthew Ferrebee · Study contact · 216-844-7064 · Matthew.Ferrebee@Uhhospitals.orgHonathan Shoag, MD · Principal investigatorMore trials in Cleveland
PA
- Thomas Jefferson Health Sidney Kimmel Cancer Center · Philadelphia, PA 19107More trials in Philadelphia
TX
- Urology Austin · Austin, TX 78745Jennifer Penshorn, RN · Study contact · 512-737-9840 · jennifer.penshorn@urologyaustin.comRebecca Rodriquez · Study contact · rebecca.rodriguez@urologyaustin.comBrian Mazzarella, MD · Principal investigatorMore trials in Austin
- Houston Metro Urology · Houston, TX 77027More trials in Houston
VA
- Virginia Urology Center · Richmond, VA 23235Jordan Moore · Study contact · 804-288-2785 · jnmoore@uro.comJ Daniel Pennington, MD · Principal investigatorMore trials in Richmond