Retrospective Evaluation of a Commercially Available Hydrogel Spacer (BP-009)

BioProtect

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: Observation

Study type: Observational

Funder types: Industry

Identifiers

NCT05423431

BP-009

Details and patient eligibility

About

Dosimetry efficacy of the hydrogel spacer.

Full description

Single arm study for evaluation of dosimetry following use of a commercially available hydrogel spacer implanted in up to 20 males who underwent radiotherapy treatment for prostate cancer. Study utilized pre and post gel insertion CT images to determine endpoints.

Enrollment: 19 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males
• At least 18 years of age
• Undergone external beam or brachy radiation therapy with a hydrogel spacer in place

Exclusion criteria

• Clinical and pathological data are not available
• Invasive adenocarcinoma that is extracapsular and demonstrates posterior extension

Trial design

19 participants in 1 patient group

Radiation with Hydrogel Spacer

Description:

Males at least 18 years of age, who underwent radiation therapy with a hydrogel spacer in place.

Treatment:

Other: Observation