Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
PSA-recurrence prostate carcinoma is associated with two general problems.
These difficulties may lead to a therapy potentially not adapted to patients situation of disease.This study aims to randomised examine if an instant radiotherapy of prostate PSA-recurrence (PSA-value between 0.2 - 0.99 ng/ml) or a delayed radiotherapy with additional imaging (PSA value >= 1 ng/ml) including PET/CT and bone scintigraphy for reliable information about tumor location and expansion is beneficial regarding therapy efficiency, quality of life and social economic aspects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| delayed radiotherapy | Experimental | PET/CT and Radiotherapy after achievement of PSA marginal value Additive imaging |
|
| instant radiotherapy | Active Comparator | Instant Radiotherapy according to guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/CT | Device | PET/CT |
| |
| Instant Radiotherapy according to guidelines |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival according to PSA-value | Subjects in the control arm have an aftertreatment period of 5 years. Follow-up period of intervention arm ends after 3 to 5 years after radiotherapy. Duration depends on the surveillance period until marginal value is reached. This period is subtracted from maximum follow-up period of 5 years. | at the end of follow-up period of 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| frequency of PSA-persistence | at the end of therapy , an expected average of 6 weeks | |
| frequency of changes in therapeutic strategies by additional diagnostics | at the end of therapy , an expected average of 6 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annedore Strnad, Dr. MHBA | Contact | +49(0)9131 85 33968 | annedore.strnad@uk.erlangen.de | |
| Eva-Maria Weiss, Dr. | Contact | +49(0)9131 85 33968 | eva-maria.weiss@uk-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Annedore Strnad, Dr. MHBA | Strahlenklinik, Universitätsklinikum Erlangen | Principal Investigator |
| Rainer Fietkau, Dr. | Strahlenklinik, Universitätsklinikum Erlangen | Study Director |
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Radiation |
Instant Radiotherapy according to guidelines |
|
| Radiotherapy after achievement of PSA marginal value | Radiation | Radiotherapy after achievement of PSA marginal value |
|
| analysis for radiation parameters, restricted to patients of initiating center | at the end of therapy , an expected average of 6 weeks |
| therapy and following costs for patients | time frame of 2 weeks before therapy starts; at the end of therapy , an expected average of 6 weeks; during follow-up each 3 months for the first 2 years, then each 6 months for the rest of follow-up period, an expected average of 2 further years |
| overall survival | at the end of therapy , an expected average of 6 weeks |
| quality of life and side effects | time frame of 2 weeks before therapy starts; at the end of therapy , an expected average of 6 weeks; during follow-up each 3 months for the first 2 years, then each 6 months for the rest of follow-up period, an expected average of 2 further years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |