Prostate Cancer, Recurrence
Conditions
Keywords
biochemical recurrence, prostate carcinoma, prostate cancer, PSA, postoperative, radiotherapy, imaging diagnostic, PET/CT, social economic aspects, quality of life
Brief summary
PSA-recurrence prostate carcinoma is associated with two general problems. 1. Localisation of PSA-recurrence is unconfident. In many cases it's not clear if a local, locoregional oder systemic relapse is available. 2. There is no standard therapy proved by randomised clinical trials. Recommended radiotherapy starting with PSA-value \< 0.5 ng/ml according to german S3 guidelines is based on retrospective data. 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.
Interventions
DEVICEPET/CT
PET/CT
RADIATIONInstant Radiotherapy according to guidelines
Instant Radiotherapy according to guidelines
RADIATIONRadiotherapy after achievement of PSA marginal value
Radiotherapy after achievement of PSA marginal value
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* postoperative, biochemical recurrent prostate carcinoma with PSA value between 0.2 to 0.99 ng/ml * prior irradiation * comprehension of study protocol content and signed informed consent form * minimum age 18 years
Exclusion criteria
* primary therapy of prostate carcinoma * PSA value \>= 1 ng/ml * diagnosed distant metastases before randomisation (osseous or systemic) * performed PET/CT before randomisation * malignant slave tumor * potent men that are not willing or are unable to apply consequent contraception * ongoing drug- and/or alcohol abuse * patients that are not willing or able to cooperate according to protocol * patients in care * patients that are not able to understand German language
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival according to PSA-value | at the end of follow-up period of 4 years | 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. |
Secondary
| Measure | Time frame |
|---|---|
| frequency of changes in therapeutic strategies by additional diagnostics | at the end of therapy , an expected average of 6 weeks |
| analysis for radiation parameters, restricted to patients of initiating center | at the end of therapy , an expected average of 6 weeks |
| frequency of PSA-persistence | at the end of therapy , an expected average of 6 weeks |
| 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 |
| 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 |
Contacts
Primary ContactAnnedore Strnad, Dr. MHBA
Backup ContactEva-Maria Weiss, Dr.
Outcome results
None listed