MedTrace Logo

Point in Time of Radiotherapy for Patients With Biochemical Recurrent Prostate Carcinoma

NCT02181192 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2016-08-01

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Annedore Strnad, Dr. MHBA · Strahlenklinik, Universitätsklinikum Erlangen

  • Rainer Fietkau, Dr. · Strahlenklinik, Universitätsklinikum Erlangen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2019-07-31
Completion
2020-07-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02181192 on ClinicalTrials.gov