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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2020-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer Recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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delayed radiotherapy

PET/CT and Radiotherapy after achievement of PSA marginal value Additive imaging

Group Type EXPERIMENTAL

PET/CT

Intervention Type DEVICE

PET/CT

Radiotherapy after achievement of PSA marginal value

Intervention Type RADIATION

Radiotherapy after achievement of PSA marginal value

instant radiotherapy

Instant Radiotherapy according to guidelines

Group Type ACTIVE_COMPARATOR

Instant Radiotherapy according to guidelines

Intervention Type RADIATION

Instant Radiotherapy according to guidelines

Interventions

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PET/CT

Intervention Type DEVICE

Instant Radiotherapy according to guidelines

Intervention Type RADIATION

Radiotherapy after achievement of PSA marginal value

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No