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This trial examines the feasibility and toxicity of focal brachytherapy in patients with low-risk prostate cancer.
Patients with low-risk prostate cancer will receive HDR-Brachytherapy: 2 x 13,5 Gy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focal Brachytherapy | Experimental | HDR-Brachytherapy, 2 fractions within at least 24 but max. 30 hours, each 13,5 Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDR-Brachytherapy | Radiation | HDR-Brachytherapy 2x 13,5 Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intensity and frequency of adverse events | 6 weeks after therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor regression | 6 weeks up to 10 years after therapy | |
| Rate of recurrences measured by PSA | 10 years after therapy | |
| Correlation of Markers RTEN, ERG, APN, Ki67, KPNA1, PSMA, FGFR1, PMP22, CDKN1A/P16, PDCD4, KLF6, PITX with PSA free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vratislav Strnad, MD | University Hospital Erlangen, Dept. of Radiooncology | Study Chair |
| Bastian Keck, MD | University Hospital Erlangen, Dept. of Urology | Study Chair |
| Alexander Cavallaro, MD | University Hospital Erlangen, Dept. of Radiology | Study Chair |
| Arndt Hartmann, MD | University Hospital Erlangen, Dept. of Pathology | Study Chair |
| Michael Lotter, Dipl.-Phys. | University Hospital Erlangen, Dept. of Radiooncology | Study Chair |
| Annedore Strnad, MD, MHBA | University Hospital Erlangen, Dept. of Radiooncology | Study Chair |
| Peter Goebell, MD | University Hospital Erlangen, Dept. of Urology | Study Chair |
| Wolfgang Uter, MD | University Erlangen; Dept. of Biometrics and Epidemiology | Study Chair |
| Michael Uder, MD | University Hospital Erlangen, Dept. of Radiology |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Recruiting | Erlangen | 91054 | Germany |
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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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| 10 years after therapy |
| Correlation of microRNA141 and -375 with outcome | 10 years after therapy |
| Feasibility, as measured by NCI-CTCAE-scale, EORTC-QLQ, IIEF, IPSS, ICIQ | 6 weeks after therapy |
| Bernd Wullich, MD | University Hospital Erlangen, Dept. of Urology | Study Chair |
| Rainer Fietkau, MD | University Hospital Erlangen, Dept. of Radiooncology | Study Chair |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |