Point in Time of Radiotherapy for Patients With Biochemical Recurrent Prostate Carcinoma
- Conditions
- Prostate CancerRecurrence
- Interventions
- Radiation: Instant Radiotherapy according to guidelinesDevice: PET/CTRadiation: Radiotherapy after achievement of PSA marginal value
- Registration Number
- NCT02181192
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 180
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description instant radiotherapy Instant Radiotherapy according to guidelines Instant Radiotherapy according to guidelines delayed radiotherapy Radiotherapy after achievement of PSA marginal value PET/CT and Radiotherapy after achievement of PSA marginal value Additive imaging delayed radiotherapy PET/CT PET/CT and Radiotherapy after achievement of PSA marginal value Additive imaging
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method frequency of changes in therapeutic strategies by additional diagnostics 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 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