Point in Time of Radiotherapy for Patients With Biochemical Recurrent Prostate Carcinoma (PROST-I)

July 29, 2016 updated by: University of Erlangen-Nürnberg Medical School

Postoperative Prostate Carcinoma Recurrence: Instant Radiotherapy Versus Radiotherapy With Additional Imaging With PSA Value >= 1

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: delayed radiotherapy
PET/CT and Radiotherapy after achievement of PSA marginal value Additive imaging
Device: PET/CT
PET/CT
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the end of follow-up period of 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
frequency of PSA-persistence
Time Frame: at the end of therapy , an expected average of 6 weeks
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Investigators

  • Principal Investigator: Annedore Strnad, Dr. MHBA, Strahlenklinik, Universitätsklinikum Erlangen
  • Study Director: Rainer Fietkau, Dr., Strahlenklinik, Universitätsklinikum Erlangen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2017

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

July 1, 2014

First Posted (Estimate)

July 3, 2014

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROST-I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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