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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|