Point in Time of Radiotherapy for Patients With Biochemical Recurrent Prostate Carcinoma (PROST-I)
Primary Purpose
Prostate Cancer, Recurrence
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PET/CT
Instant Radiotherapy according to guidelines
Radiotherapy after achievement of PSA marginal value
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring biochemical recurrence, prostate carcinoma, prostate cancer, PSA, postoperative, radiotherapy, imaging diagnostic, PET/CT, social economic aspects, quality of life
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
delayed radiotherapy
instant radiotherapy
Arm Description
PET/CT and Radiotherapy after achievement of PSA marginal value Additive imaging
Instant Radiotherapy according to guidelines
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
frequency of PSA-persistence
frequency of changes in therapeutic strategies by additional diagnostics
analysis for radiation parameters, restricted to patients of initiating center
therapy and following costs for patients
overall survival
quality of life and side effects
Full Information
NCT ID
NCT02181192
First Posted
February 18, 2014
Last Updated
July 29, 2016
Sponsor
University of Erlangen-Nürnberg Medical School
1. Study Identification
Unique Protocol Identification Number
NCT02181192
Brief Title
Point in Time of Radiotherapy for Patients With Biochemical Recurrent Prostate Carcinoma
Acronym
PROST-I
Official Title
Postoperative Prostate Carcinoma Recurrence: Instant Radiotherapy Versus Radiotherapy With Additional Imaging With PSA Value >= 1
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2017 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Recurrence
Keywords
biochemical recurrence, prostate carcinoma, prostate cancer, PSA, postoperative, radiotherapy, imaging diagnostic, PET/CT, social economic aspects, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
delayed radiotherapy
Arm Type
Experimental
Arm Description
PET/CT and Radiotherapy after achievement of PSA marginal value Additive imaging
Arm Title
instant radiotherapy
Arm Type
Active Comparator
Arm Description
Instant Radiotherapy according to guidelines
Intervention Type
Device
Intervention Name(s)
PET/CT
Intervention Description
PET/CT
Intervention Type
Radiation
Intervention Name(s)
Instant Radiotherapy according to guidelines
Intervention Description
Instant Radiotherapy according to guidelines
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy after achievement of PSA marginal value
Intervention Description
Radiotherapy after achievement of PSA marginal value
Primary Outcome Measure Information:
Title
Disease-free survival according to PSA-value
Description
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.
Time Frame
at the end of follow-up period of 4 years
Secondary Outcome Measure Information:
Title
frequency of PSA-persistence
Time Frame
at the end of therapy , an expected average of 6 weeks
Title
frequency of changes in therapeutic strategies by additional diagnostics
Time Frame
at the end of therapy , an expected average of 6 weeks
Title
analysis for radiation parameters, restricted to patients of initiating center
Time Frame
at the end of therapy , an expected average of 6 weeks
Title
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
Title
overall survival
Time Frame
at the end of therapy , an expected average of 6 weeks
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annedore Strnad, Dr. MHBA
Phone
+49(0)9131 85 33968
Email
annedore.strnad@uk.erlangen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Eva-Maria Weiss, Dr.
Phone
+49(0)9131 85 33968
Email
eva-maria.weiss@uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annedore Strnad, Dr. MHBA
Organizational Affiliation
Strahlenklinik, Universitätsklinikum Erlangen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rainer Fietkau, Dr.
Organizational Affiliation
Strahlenklinik, Universitätsklinikum Erlangen
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Point in Time of Radiotherapy for Patients With Biochemical Recurrent Prostate Carcinoma
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