Point in Time of Radiotherapy for Patients With Biochemical Recurrent Prostate Carcinoma

Study Overview
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Brief Summary
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PSA-recurrence prostate carcinoma is associated with two general problems. Localisation of PSA-recurrence is unconfident. In many cases it's not clear if a local, locoregional oder systemic relapse is available. 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.

Official Title
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Postoperative Prostate Carcinoma Recurrence: Instant Radiotherapy Versus Radiotherapy With Additional Imaging With PSA Value >= 1

Conditions
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Prostate Cancer, Recurrence

Intervention / Treatment
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* Device: PET/CT
* Radiation: Instant Radiotherapy according to guidelines
* Radiation: Radiotherapy after achievement of PSA marginal value


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: delayed radiotherapy<br>PET/CT and Radiotherapy after achievement of PSA marginal value Additive imaging | Device: PET/CT<br>* PET/CT<br>Radiation: Radiotherapy after achievement of PSA marginal value<br>* Radiotherapy after achievement of PSA marginal value<br>|
| Active Comparator: instant radiotherapy<br>Instant Radiotherapy according to guidelines | Radiation: Instant Radiotherapy according to guidelines<br>* Instant Radiotherapy according to guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PSA, biochemical recurrence, prostate carcinoma, prostate cancer, postoperative, radiotherapy, imaging diagnostic, PET/CT, social economic aspects, quality of life