Health TrialsbyHealthPanel

Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial

ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorPalette Life Sciences, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Known allergy to hyaluronic acid

Pathologic T4 disease

Prior local prostate cancer therapy including cryotherapy or brachytherapy.

Prior post-prostatectomy or pelvic radiation therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Treatment ArmsExperimental treatment 2 interventions
Group B: Control ArmSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months

Secondary outcomes

1

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.

Time frame
3 Months
2

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.

Time frame
3 months
3

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.

Time frame
3 months

Other outcomes

1

Adverse Events

All adverse events

Time frame
3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Palette Life Sciences, Inc.

Lead sponsor

Teleflex

Collaborator

Source ClinicalTrials.gov
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