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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00004405 | Registry Identifier | Freiburger Register |
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Insufficient Recruitment
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4arms preference based Study to compare four therapy options in prostate cancer with low or early intermediate risk
The study will compare four possible therapy options for treatment of newly diagnosed prostate cancer with low or "early intermediate" risk according to the patients preferences.
The Following hypotheses will be tested:
That for patients with newly diagnosed prostate cancer will be randomized into one of the four treatment arms. Randomization may be limited to at least two of the four treatment arms if a patient refuses one or two of the four treatment arms according to his own preference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radical prostatectomy | Experimental | Procedure/Surgery: radical prostatectomy |
|
| percutaneous radiation therapy | Experimental | Radiation: percutaneous radiation therapy |
|
| permanent seed implantation | Experimental | Radiation: permanent seed implantation |
|
| Active Surveillance | Experimental | Procedure/Surgery: Active Surveillance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radical prostatectomy | Procedure |
| ||
| percutaneous radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate cancer-specific survival | minimal observation time of 13 years for last study patient |
| Measure | Description | Time Frame |
|---|---|---|
| - Overall survival | minimal observation time of 13 years for last study patient | |
| - Time to onset of hormone therapy | 17 years | |
| - Occurrence of the first progression on hormone therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Stöckle, Prof. Dr. | Klinik für Urologie und Kinderurologie der Universität des Saarlandes | Principal Investigator |
| Thomas Wiegel, Prof. Dr. | Klinik für Strahlentherapie und Radioonkologie der Universität Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum | Ulm | Albert-Einstein-Allee 23 | 89081 | Germany | ||
| Universitätsklinikum |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32189088 | Result | Albers P, Wiegel T, Schmidberger H, Bussar-Maatz R, Harter M, Kristiansen G, Martus P, Meisner C, Wellek S, Grozinger K, Renner P, Burmester M, Schneider F, Stockle M. Termination rates and histological reclassification of active surveillance patients with low- and early intermediate-risk prostate cancer: results of the PREFERE trial. World J Urol. 2021 Jan;39(1):65-72. doi: 10.1007/s00345-020-03154-7. Epub 2020 Mar 18. | |
| 32886212 |
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| Radiation |
|
| permanent seed implantation | Radiation |
|
| Active Surveillance | Procedure |
|
| 17 years |
| - Quality of life on EORTC-QLQ-C30 with additional modul PCA (EORTCQLQ- PR25) as well as HADS-D at baseline | before and 3 Mon. after therapy as well as after 1, 2, 3, 5, 7, 10 and 13 years |
| - Complications / Safety | median 15 years |
| Homburg/Saar |
| Kirrberger Straße |
| 66424 |
| Germany |
| Result |
| Wiegel T, Albers P, Bartkowiak D, Bussar-Maatz R, Harter M, Kristiansen G, Martus P, Wellek S, Schmidberger H, Grozinger K, Renner P, Schneider F, Burmester M, Stockle M. Results of a randomized trial of treatment modalities in patients with low or early-intermediate risk prostate cancer (PREFERE trial). J Cancer Res Clin Oncol. 2021 Jan;147(1):235-242. doi: 10.1007/s00432-020-03327-2. Epub 2020 Sep 4. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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