Prospective Evaluation of a Commercially Available Hydrogel Spacer (BP-008)

BioProtect

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: Observation

Study type: Observational

Funder types: Industry

Identifiers

NCT05323747

BP-008

Details and patient eligibility

About

Dosimetry efficacy evaluation of the hydrogel spacer

Full description

Single arm study for evaluation of dosimetry following use of a commercially available hydrogel spacer implanted in 20 males undergoing radiotherapy to treat prostate cancer. Study will utilize pre and post gel insertion CT images to determine the endpoints.

Enrollment: 20 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males
• At lease 18 years of age
• Undergoing external beam or brachy radiation therapy with a hydrogel spacer

Exclusion criteria

• Invasive adenocarcinoma that is extracapsular and demonstrates posterior extension

Trial design

20 participants in 1 patient group

Radiation with Hydrogel Spacer

Description:

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

Treatment:

Other: Observation