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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.
Multi-center, retrospective, observational study for assessment of rectal dose reduction following implantation of the BioProtect Balloon Implant System
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other | Assessment of rectal dosimetry change from pre-insertion to post-insertion in subjects with prostate cancer who have undergone radiotherapy with implantabale spacers. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Rectal radiation Dose | Dosimetry change to organs at risk in subjects with prostate cancer who have undergone radiotherapy with implantable spacers when compared to pre-implantation values. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate to rectum spacing | Measurement of prostate-rectum spacing | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events throughout the treatment course and follow up period | 3 months |
Inclusion Criteria:
- Males at least 18 years of age, who have undergone radiation therapy with implantable spacers
Exclusion Criteria:
Prostate Cancer
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Prostate Cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Maria Skłodowska, Curie (MCMCC) | Warsaw | Poland | ||||
| Cuf Porto institution |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| Porto |
| Portugal |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |