Point in Time of Radiotherapy for Patients With Biochemical Recurrent Prostate Carcinoma (PROST-I)
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|ClinicalTrials.gov Identifier: NCT02181192|
Recruitment Status : Not yet recruiting
First Posted : July 3, 2014
Last Update Posted : August 1, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Recurrence||Device: PET/CT Radiation: Instant Radiotherapy according to guidelines Radiation: Radiotherapy after achievement of PSA marginal value||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Postoperative Prostate Carcinoma Recurrence: Instant Radiotherapy Versus Radiotherapy With Additional Imaging With PSA Value >= 1|
|Study Start Date :||July 2017|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2020|
Experimental: delayed radiotherapy
PET/CT and Radiotherapy after achievement of PSA marginal value Additive imaging
Radiation: Radiotherapy after achievement of PSA marginal value
Radiotherapy after achievement of PSA marginal value
Active Comparator: instant radiotherapy
Instant Radiotherapy according to guidelines
Radiation: Instant Radiotherapy according to guidelines
Instant Radiotherapy according to guidelines
- Disease-free survival according to PSA-value [ Time Frame: 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.
- frequency of PSA-persistence [ Time Frame: at the end of therapy , an expected average of 6 weeks ]
- frequency of changes in therapeutic strategies by additional diagnostics [ Time Frame: at the end of therapy , an expected average of 6 weeks ]
- analysis for radiation parameters, restricted to patients of initiating center [ Time Frame: at the end of therapy , an expected average of 6 weeks ]
- therapy and following costs for patients [ Time Frame: 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 [ Time Frame: at the end of therapy , an expected average of 6 weeks ]
- quality of life and side effects [ Time Frame: 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02181192
|Contact: Annedore Strnad, Dr. MHBA||+49(0)9131 85 email@example.com|
|Contact: Eva-Maria Weiss, Dr.||+49(0)9131 85 firstname.lastname@example.org|
|Principal Investigator:||Annedore Strnad, Dr. MHBA||Strahlenklinik, Universitätsklinikum Erlangen|
|Study Director:||Rainer Fietkau, Dr.||Strahlenklinik, Universitätsklinikum Erlangen|