Prostate Cancer
Conditions
Keywords
Prostate, Prostate Cancer, Spacer, Perirectal spacer
Brief summary
Dosimetry efficacy evaluation of the hydrogel spacer
Detailed 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.
Interventions
OTHERObservation
Assessment of rectal dosimetry change from pre-insertion to post-insertion in subjects with prostate cancer who have undergone radiotherapy with a hydrogel spacer.
Sponsors
BioProtect
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dosimetry changes | 1 month | Assessment of rectal radiation exposure as compared between rectal dose volume histograms calculated for pre and post Hydrogel Injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prostate to rectum spacing | 1 month | Prostate to rectum spacing measurement for evaluation of the perirectal distance post-hydrogel insertion |
Countries
United States
Outcome results
None listed