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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
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Tracking Information
First Submitted Date  ICMJE February 18, 2014
First Posted Date  ICMJE July 3, 2014
Last Update Posted Date August 1, 2016
Study Start Date  ICMJE July 2017
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02181192 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Point in Time of Radiotherapy for Patients With Biochemical Recurrent Prostate Carcinoma
Official Title  ICMJE Postoperative Prostate Carcinoma Recurrence: Instant Radiotherapy Versus Radiotherapy With Additional Imaging With PSA Value >= 1
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer
  • Recurrence
Intervention  ICMJE
  • Device: PET/CT
    PET/CT
  • Radiation: Instant Radiotherapy according to guidelines
    Instant Radiotherapy according to guidelines
  • Radiation: Radiotherapy after achievement of PSA marginal value
    Radiotherapy after achievement of PSA marginal value
Study Arms  ICMJE
  • Experimental: delayed radiotherapy
    PET/CT and Radiotherapy after achievement of PSA marginal value Additive imaging
    Interventions:
    • Device: PET/CT
    • Radiation: Radiotherapy after achievement of PSA marginal value
  • Active Comparator: instant radiotherapy
    Instant Radiotherapy according to guidelines
    Intervention: Radiation: Instant Radiotherapy according to guidelines
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2014)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Annedore Strnad, Dr. MHBA +49(0)9131 85 33968 annedore.strnad@uk.erlangen.de
Contact: Eva-Maria Weiss, Dr. +49(0)9131 85 33968 eva-maria.weiss@uk-erlangen.de
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02181192
Other Study ID Numbers  ICMJE PROST-I
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Erlangen-Nürnberg Medical School
Study Sponsor  ICMJE University of Erlangen-Nürnberg Medical School
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Annedore Strnad, Dr. MHBA Strahlenklinik, Universitätsklinikum Erlangen
Study Director: Rainer Fietkau, Dr. Strahlenklinik, Universitätsklinikum Erlangen
PRS Account University of Erlangen-Nürnberg Medical School
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP