Prostate Cancer
Conditions
Brief summary
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.
Detailed description
Multi-center, retrospective, observational study for assessment of rectal dose reduction following implantation of the BioProtect Balloon Implant System
Interventions
OTHERObservation
Assessment of rectal dosimetry change from pre-insertion to post-insertion in subjects with prostate cancer who have undergone radiotherapy with implantabale spacers.
Sponsors
BioProtect
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Rectal radiation Dose | 1 month | Dosimetry change to organs at risk in subjects with prostate cancer who have undergone radiotherapy with implantable spacers when compared to pre-implantation values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prostate to rectum spacing | 1 month | Measurement of prostate-rectum spacing |
Other
| Measure | Time frame |
|---|---|
| Incidence of adverse events throughout the treatment course and follow up period | 3 months |
Countries
Poland, Portugal
Outcome results
None listed