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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
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

    First Posted
    February 18, 2014
    Last Updated
    July 29, 2016
    Sponsor
    University of Erlangen-Nürnberg Medical School
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    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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