A Study Of Barrigel For Radiation Intensification In Image-Guided HDR Therapy

Overview

About this study

The purpose pf this study is to assess the ability to dose escalate to the DIL with greater than 90% of the DIL achieving boost prescription dose by using Barrigel during HDR brachytherapy without exceeding priority 1 OAR constraints. . The dose escalation to the DIL translates to achieving V122.2% > 90% (i.e., 90% of the DIL receiving 122.2% of the prescribed dose) in the monotherapy cohort, V126.7% > 90% in the boost cohort, and V120% > 90% in the re-irradiation cohort.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Gender assigned male at birth.

  • Age ≥18 years.

  • Histological confirmation of prostate adenocarcinoma, including biopsy proven locally recurrent disease in in the Local Recurrence Arm.

  • At least one PI-RADS 4 or 5 lesion visible on mpMRI.

  • ECOG Performance Status ≤2 (Appendix I).

  • Ability to undergo anesthesia and HDR brachytherapy procedures as determined by treating physician and anesthesiologist.

  • Willing to complete requirements for follow-up (during Active Monitoring Phase).

Exclusion Criteria:

  • Prior prostate surgery including prostatectomy or TURP.

  • Prior bladder outlet obstruction procedures including TURP, HoLEP, TUVRP, etc.

  • Contraindications to RT including uncontrolled inflammatory bowel disease, ATM mutation, and Xeroderma pigmentosum mutation.

  • Concurrent antineoplastic agents (chemotherapy).

  • Previous or concurrent malignancy other than non-melanoma skin cancer, indolent lymphoma, or chronic myelogenous leukemia, unless continuously disease-free ≥5 years.

  • Medical or psychiatric conditions that preclude informed decision-making or adherence with the protocol-defined treatment or follow-up.

  • Prostate gland volume >80 cc based on MRI, and/or International Prostate Symptom Score (IPSS) composite score >17. Prostate volume >60cc is a relative contraindication and based on physician discretion.

  • Body weight >200 kilogram.

  • Inability to undergo general anesthesia

  • Undergoing LDR brachytherapy

  • Unable to undergo prostate mpMRI

  • Allergy to hyaluranic acid

  • Clinical stage T4 disease or evidence of distant metastases.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/13/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mark Waddle, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available