Clinical trial NCT02181192: Point in Time of Radiotherapy for Patients With Biochemical Recurrent Prostate Carcinoma
Official title: Postoperative Prostate Carcinoma Recurrence: Instant Radiotherapy Versus Radiotherapy With Additional Imaging With PSA Value >= 1
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Recurrence
Keywords: biochemical recurrence
prostate carcinoma
prostate cancer
PSA
postoperative
radiotherapy
imaging diagnostic
PET/CT
social economic aspects
quality of life
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2014-07-03
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Disease-free survival according to PSA-value
timeFrame: at the end of follow-up period of 4 years
Secondary outcomes:
measure: frequency of PSA-persistence
timeFrame: at the end of therapy , an expected average of 6 weeks
measure: frequency of changes in therapeutic strategies by additional diagnostics
timeFrame: at the end of therapy , an expected average of 6 weeks
measure: analysis for radiation parameters, restricted to patients of initiating center
timeFrame: at the end of therapy , an expected average of 6 weeks
measure: therapy and following costs for patients
timeFrame: 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
measure: overall survival
timeFrame: at the end of therapy , an expected average of 6 weeks
measure: quality of life and side effects
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Strahlenklinik, Universitätsklinikum Erlangen
name: Annedore Strnad, Dr. MHBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Strahlenklinik, Universitätsklinikum Erlangen
name: Rainer Fietkau, Dr.
role: STUDY_DIRECTOR
References: