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

Prostate Cancer Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Prostate Cancer
• Prostatic Neoplasms
• Recurrence

• NCT number: NCT02181192
• Study type: Interventional
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Annedore Strnad, Dr. MHBA
• Phone: +49(0)9131 85 33968
• Email: annedore.strnad@uk.erlangen.de
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2017
• Completion date: July 2020