Retrospective Evaluation of Commercial Spacers in Prostate Cancer Patients (CLP-10095)

BioProtect

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: Observation

Study type: Observational

Funder types: Industry

Identifiers

NCT05354427

CLP-10095

Details and patient eligibility

About

Assessment of efficacy and safety of implantable spacers when used to reduce the radiation dose delivered to the organs at risk in prostate cancer patients undergoing radiotherapy.

Full description

Multi-center, retrospective, observational study for assessment of rectal dose reduction following implantation of the BioProtect Balloon Implant System

Enrollment: 175 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

- Males at least 18 years of age, who have undergone radiation therapy with implantable spacers

Exclusion criteria

• Patients whose clinical and pathological data are not available.
• Patients have been histologically diagnosed with invasive adenocarcinoma that is extracapsular with posterior extension