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Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06496256 ist eine interventionsstudie zur Untersuchung von Prostatakrebs und hat den Status offene rekrutierung. Die Studie startete am 31. Oktober 2024 und soll 84 Teilnehmer aufnehmen. Durchgeführt von Palette Life Sciences, Inc. ist der Abschluss für 31. Dezember 2027 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 29. Mai 2025 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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.

Offizieller Titel

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

Erkrankungen
Prostatakrebs
Weitere Studien-IDs
  • 0423-0001
NCT-Nummer
NCT06496256
Studienbeginn (tatsächlich)
2024-10-31
Zuletzt aktualisiert
2025-05-29
Studienende (vorauss.)
2027-12-31
Geplante Rekrutierung
84
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Primäres Ziel
Prävention
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellTreatment Arms
Subjects will be injected Barrigel between the rectum and prostate bed using transrectal ultrasound for guidance.
Barrigel
Barrigel is an absorbable gel based on Non-Animal Stabilized Hyaluronic Acid (NASHA™) that is injected into the peri-rectal space
Transrektaler Ultraschall
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
Schein-VergleichspräparatControl 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.
Transrektaler Ultraschall
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
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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.
3 months
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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.
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.
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.
3 months
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Männlich
  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

  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
Palette Life Sciences, Inc. logoPalette Life Sciences, Inc.
Teleflex logoTeleflex
Zentrale Studienkontakte
Kontakt: Joseph Onokwai, MD, MPH, PhD, 7738864397, [email protected]
Kontakt: Cliff Kline, 8054569653, [email protected]
5 Studienstandorte in 2 Ländern

Massachusetts

Dana Farber Cancer Institute, Boston, Massachusetts, 02215, United States
Martin King, MD, Kontakt
Kontakt, [email protected]
Martin King, MD, Hauptprüfer
Offene Rekrutierung

New Jersey

Summit Health, Clifton, New Jersey, 07013, United States
Kelly Ritter, Kontakt, 903-361-0748, [email protected]
Jocelyn Remuska, Kontakt, [email protected]
Dr. Glen Gejerman, MD, Hauptprüfer
Offene Rekrutierung

Texas

Urology Austin, Austin, Texas, 78745, United States
Jennifer Penshorn, RN, Kontakt, 512-737-9840, [email protected]
Rebecca Rodriquez, Kontakt, [email protected]
Brian Mazzarella, MD, Hauptprüfer
Offene Rekrutierung
Houston Metro Urology, Houston, Texas, 77027, United States
Aktiv, nicht rekrutierend

Victoria

GenesisCare Ringwood, Melbourne, Victoria, 3002, Australia
Michelle Starman, Kontakt, +388703388, [email protected]
Prof Michael Chao, MD, Hauptprüfer
Offene Rekrutierung